Meningococcal Groups A, C, Y, and W-135 Vaccine

[Section Outline]

Risks of Exposure and Infection
Choice of Meningococcal Groups A, C, Y, and W-135 Vaccines
Primary and Booster Immunization
Outbreak Control

Meningococcal (groups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine (MenACWY-D; Menactra^®), meningococcal (groups A, C, Y and W-135) oligosaccharide diphtheria CRM₁₉₇ conjugate vaccine (MenACWY-CRM; Menveo^®), and meningococcal (groups A, C, Y and W-135) polysaccharide tetanus toxoid conjugate vaccine (MenACWY-TT; MenQuadfi^®) are quadrivalent conjugated meningococcal groups A, C, Y, and W-135 (MenACWY) vaccines used to stimulate active immunity to infection caused by Neisseria meningitidis serogroups represented in the vaccines.1,105,108,152,199,200,228

MenACWY vaccines are used for primary and booster immunization against infection caused by N. meningitidis serogroups A, C, Y, and W-135.1,105,108,152,199,200,228 MenACWY vaccines also may be used as an adjunct to anti-infective prophylaxis in household and other contacts of individuals with invasive meningococcal disease when cluster cases or outbreaks are caused by N. meningitidis serogroups represented in the vaccines.105,166,235

MenACWY vaccines will not stimulate immunity to meningococcal infection caused by N. meningitidis serogroups not represented in the vaccines (e.g., serogroup B) or to infections caused by other pathogens.1,105,108,152,166,228

The US Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP), American Academy of Pediatrics (AAP), and other experts recommend routine primary immunization against meningococcal serogroups A, C, Y, and W-135 infection in all adolescents using MenACWY vaccine, preferably at 11 through 12 years of age, followed by a booster dose at 16 years of age.105,199,228 These experts recommend catch-up vaccination with MenACWY vaccine at 13 through 18 years of age for those not previously vaccinated against meningococcal serogroups A, C, Y, and W-135 infection.105,199,228 Catch-up vaccination with MenACWY vaccine also is recommended for all first-year college students living in residence halls if they did not receive a dose of the vaccine on or after their 16th birthday.199,200,228

ACIP, AAP, and other experts also recommend routine primary and booster immunization against meningococcal serogroups A, C, Y, and W-135 infection using MenACWY vaccine in selected adults, adolescents, children, and infants 2 months of age or older at increased risk for the disease because of certain chronic medical conditions or treatment (e.g., persistent complement component deficiencies, treatment with a complement inhibitor, anatomic or functional asplenia, human immunodeficiency virus [HIV] infection) or because they will be traveling to or residing in areas with hyperendemic or epidemic meningococcal disease caused by serogroups represented in the vaccine.105,156,199,200,228 Primary and booster immunization with MenACWY vaccine also is recommended for some other individuals at increased risk for meningococcal disease (e.g., certain health-care and laboratory personnel, military recruits).200,228,235

Risks of Exposure and Infection

N. meningitis can cause invasive meningococcal disease that usually presents as acute, severe and potentially life-threatening meningitis and/or meningococcemia with abrupt onset.105,166,228 Less frequently, N. meningitidis infection results in focal disease (e.g., pneumonia, arthritis, otitis media, epiglottitis).105,166,228 Based on chemical differences in the antigenic capsular polysaccharide, at least 12 different serogroups of N. meningitidis have been identified.14,105,166,228 In the US, serogroups B, C, and Y cause most cases of meningococcal disease and serogroup W-135 causes a small percentage of cases.105,166,228,237 The proportion of cases caused by each serogroup has changed over time and varies based on geographic location and age group.105,166,228,237 During 2015-2018, serogroups B and C caused 42 and 26%, respectively, of cases where the serogroup was known; serogroups W and Y and nongroupable strains each caused 9-14% of cases.228 Serogroup B causes approximately 60% of cases of meningococcal disease reported in the US in infants and children younger than 5 years of age.105,166,237 Serogroups C, Y, or W-135 cause approximately 60% of cases of meningococcal disease reported in the US among individuals 24 years of age or older.166 (See Neisseria meningitidis and Infection under Pharmacology.)

The overall annual incidence of meningococcal disease has decreased steadily in the US from 1.2 cases per 100,000 population in 1996 to 0.1 cases per 100,000 population in 2018.228 During 2015-2018, approximately 360 cases of meningococcal disease occurred annually in the US.166,228 In 2018, there were about 329 cases of meningococcal disease reported to CDC (0.11 cases per 100,000).166,237 Although the overall incidence of meningococcal disease in the US has been historically low during the last 10-15 years,105,166,228 the overall case fatality rate for invasive meningococcal disease has remained at 10-15% (even with appropriate anti-infective treatment)105,166,228,237 and the fatality rate can be higher in those with meningococcemia.166 In addition, meningococcal infection can result in substantial morbidity; long-term sequelae (e.g., hearing loss, neurologic disability, digit or limb amputations) are reported in up to 20% of patients.105,166,228,237

Although the risk of exposure to meningococcal disease is considered low in the general US population,34,78,79,228,237 the risk is increased in individuals who have certain underlying chronic medical conditions that make them more susceptible to severe and/or recurrent invasive meningococcal disease.53,79,80,81,134,166,228 The risk of meningococcal disease also is increased in certain age groups, including infants and children 5 years of age or younger, adolescents and young adults 16 through 23 years of age (especially first-year college students living in dormitories), and geriatric adults 65 years of age or older,105,228,237 and in certain health-care and laboratory personnel,228 military recruits,228,235 and individuals who travel to or reside in areas outside the US where meningococcal disease is highly endemic or epidemic.79,105,115,228

Individuals with complement component deficiencies (e.g., C3, C5-C9, properdin, factor H, factor D) are more susceptible to N. meningitidis infection, particularly serogroup Y, than complement-sufficient individuals,34,67,79,80,81,82,83,85,105,228 and it has been estimated that the risk of infection is 10,000 times greater in such individuals.228 In addition, complement component-deficient individuals frequently experience recurrent meningococcal disease67,80,228 since their immune response to natural infection may be less complete than that of complement-sufficient individuals.67 Individuals receiving treatment with a complement inhibitor (e.g., eculizumab, ravulizumab) also are at substantially increased risk for meningococcal disease and such individuals remain at risk for meningococcal disease even after immunization with MenACWY vaccine.108,228,229,230

Individuals with functional or anatomic asplenia (including sickle cell disease) appear to be at increased risk for severe meningococcal disease,66,68,134,228 possibly because they may not be able to effectively clear encapsulated bacteria from the bloodstream.66,68

Individuals with other conditions associated with immunosuppression, including individuals with HIV infection,134,156,228 and hematopoietic cell transplant recipients134 also may be at increased risk for meningococcal disease.

While the incidence of meningococcal disease in college students appears to be similar to or somewhat lower than that reported for the general population of individuals 18-22 years of age, there is some evidence that first-year college students who reside on campus in dormitory housing are at higher risk of the disease than other students.100,105,228

Health-care personnel who have close contact with nasopharyngeal secretions from a patient with invasive meningococcal disease (e.g., unprotected mouth-to-mouth resuscitation, unprotected contact during endotracheal intubation or endotracheal tube management) during the 7 days before onset of disease in the patient or before anti-infective therapy is initiated in the patient are at increased risk of infection.228,235 Research, industrial, and clinical laboratory personnel (e.g., microbiologists) exposed to isolates of N. meningitidis or solutions containing the organism that may be aerosolized also are at increased risk of infection.166,228,235

N. meningitidis is transmitted person to person by the respiratory route and the principal type of exposure that places an individual at increased risk of meningococcal infection is close personal contact (household or child-care or nursery school contact) with an individual with invasive meningococcal disease or direct exposure to nasopharyngeal secretions from an infected individual.14,62,79,105,166,228,235 However, many cases of meningococcal disease in the US occur in individuals who have had no known exposure to an individual with invasive disease and presumably acquired infection from an asymptomatic carrier.90 N. meningitidis can be introduced into a household by an individual who is an asymptomatic N. meningitidis carrier; the infection then spreads to one or more susceptible household contacts by exposure to oropharyngeal secretions through close intimate contact (kissing) or sharing toothbrushes or eating or drinking utensils.33,49,105,166 The rate of infection in household contacts exposed to an individual with sporadic meningococcal disease has been estimated to be 2-4 cases per 1000 population or 500-800 times greater than that for the general population.166 Casual contacts who have no history of direct exposure to an index case's oropharyngeal secretions (e.g., school or work mates) and individuals who had only indirect contact with the index case (only contact was with a high-risk contact of the index case) are not at increased risk of infection.90 The infection risk in household or close personal contacts following exposure to an index case is inversely related to the age of the contact, and young children are at greatest risk of infection.33,79 The attack rate after household or other close contact is highest immediately after onset of the disease in the index case,228 and the majority of secondary cases occur within 2 weeks after contact and infection in susceptible individuals.79

Choice of Meningococcal Groups A, C, Y, and W-135 Vaccines

There are 3 different conjugated MenACWY vaccines commercially available in the US for active immunization for prevention of invasive meningococcal disease caused by serogroups A, C, Y, and W-135: MenACWY-D, MenACWY-CRM, and MenACWY-TT.1,105,108,152,228

These vaccines contain A, C, Y, and W-135 capsular polysaccharide antigens extracted from N. meningitidis and stimulate active immunity to infection caused by the serotypes represented in the vaccines.1,105,108,152,228 The antigens contained in MenACWY-D are conjugated to diphtheria toxoid protein,108,228 the antigens contained in MenACWY-CRM are conjugated to diphtheria CRM₁₉₇ protein,152 and the antigens contained in MenACWY-TT are conjugated to tetanus toxoid protein.1 Conjugation of meningococcal capsular polysaccharide antigens to protein carriers with T-cell epitopes changes the immune response to the vaccine polysaccharides from T-cell-independent to T-cell-dependent, resulting in an improved primary response to the antigens and a strong anamnestic response after re-exposure to the antigens.108

MenACWY-D is labeled by FDA for primary immunization in individuals 9 months through 55 years of age and for booster immunization in those 15 through 56 years of age.108

MenACWY-CRM is labeled by FDA for primary immunization in individuals 2 months through 55 years of age and for booster immunization in those 15 through 55 years of age.152

MenACWY-TT is labeled by FDA for primary immunization in individuals 2 years of age or older and for booster immunization in those 15 years of age or older.1

ACIP and AAP do not state a preference for MenACWY-D, MenACWY-CRM, or MenACWY-TT and state that any age-appropriate MenACWY vaccine can be used for primary immunization and/or booster doses.134,199,200,228 However, the dosage schedules (i.e., number and timing of doses for primary immunization) differ depending on which vaccine is used.108,152,199,228

Primary and Booster Immunization

Infants 2 through 23 Months of Age

ACIP, AAP, and other experts recommend routine primary immunization against meningococcal serogroups A, C, Y, and W-135 disease using an age-appropriate MenACWY vaccine in selected infants 2 months through 23 months of age at increased risk for meningococcal disease because of certain chronic medical conditions or treatment (e.g., persistent complement component deficiencies, treatment with a complement inhibitor, anatomic or functional asplenia, HIV infection) or because they will be traveling to or residing in areas with hyperendemic or epidemic meningococcal disease.156,199,228

ACIP and AAP state that routine primary immunization against meningococcal serogroups A, C, Y, and W-135 disease is not recommended in infants who are not at increased risk.105,228

For primary immunization against meningococcal disease in infants younger than 24 months of age, MenACWY-CRM is labeled for use in infants 2 months of age or older152 and MenACWY-D is labeled for use in infants 9 months of age or older.108

Children 2 through 10 Years of Age

ACIP, AAP, and other experts recommend routine primary immunization against meningococcal serogroups A, C, Y, and W-135 disease in selected children 2 through 10 years of age at increased risk for meningococcal disease because of certain chronic medical conditions or treatment (e.g., persistent complement component deficiencies, treatment with a complement inhibitor, anatomic or functional asplenia, HIV infection) or because they will be traveling to or residing in areas with hyperendemic or epidemic meningococcal disease.105,156,199,228

ACIP and AAP state that routine primary immunization against meningococcal serogroups A, C, Y, and W-135 disease is not recommended in children 2 through 10 years who are not at increased risk for meningococcal disease.105,228

Any MenACWY vaccine (MenACWY-D, MenACWY-CRM, MenACWY-TT) can be used in children 2 years of age or older.1,108,152

Adolescents 11 through 18 Years of Age

ACIP, AAP, and other experts recommend routine primary immunization against meningococcal serogroups A, C, Y, and W-135 disease in all young adolescents with a primary dose of MenACWY vaccine at 11 through 12 years of age, followed by a booster dose at 16 years of age.105,199,228 The booster dose is considered necessary because immunologic data indicate waning effectiveness against meningococcal disease and persistence studies conducted in adolescents and adults during the first 5 years after the primary dose indicate variable levels of antibody against the different meningococcal serogroups.228

Catch-up immunization against meningococcal serogroups A, C, Y, and W-135 disease with MenACWY vaccine is recommended at the first opportunity for all older adolescents 13 through 18 years of age who were not vaccinated at 11 through 12 years of age.105,199,228 Adolescents who receive their first dose of MenACWY vaccine at 13 through 15 years of age should receive a booster dose at 16 through 18 years of age.199,228 A booster dose is not needed in otherwise healthy individuals who receive the first dose of MenACWY vaccine at 16 years of age or older.199,228

Any MenACWY vaccine (MenACWY-D, MenACWY-CRM, MenACWY-TT) can be used in adolescents.1,108,152

Adults

College Students

ACIP, AAP, and other experts recommend that all first-year college students who plan to live in dormitories receive primary immunization with MenACWY vaccine if they did not receive a dose of the vaccine at 16 years of age or older.200,228

In 2000, ACIP and AAP first recommended that colleges, public health agencies, and providers of medical care to incoming and current college freshmen inform these students and their parents about meningococcal disease and the benefits of vaccination since college freshmen (particularly those who reside in dormitory housing) are at increased risk for meningococcal disease compared with other individuals the same age and stated that MenACWY vaccine should be provided or made easily available to those college freshmen who wanted to reduce their risk for meningococcal disease.106 Beginning in May 2005, ACIP strengthened their recommendations regarding vaccination against meningococcal disease for college students by recommending universal immunization against N. meningitidis serogroups A, C, Y, and W-135 infection for all college freshmen who plan to live in dormitories.106,228

ACIP states that all first-year college students living in residence halls should receive at least 1 dose of MenACWY vaccine within 5 years before college entry.228 The preferred timing of the most recent dose is on or after their 16th birthday.228 If only 1 dose of vaccine was administered before the 16th birthday, a booster dose should be administered before enrollment.228 Adolescents who received a first dose of MenACWY vaccine after their 16th birthday do not need another dose before college entry unless more than 5 years have elapsed since the dose.228

Any MenACWY vaccine (MenACWY-D, MenACWY-CRM, MenACWY-TT) can be used to ensure protection in first-year college students who plan to live in dormitories.1,108,152

Other Adults

ACIP, AAP, and other experts recommend routine primary immunization against meningococcal serogroups A, C, Y, and W-135 disease in selected adults at increased risk for meningococcal disease because of certain chronic medical conditions or treatment (e.g., persistent complement component deficiencies, treatment with a complement inhibitor, anatomic or functional asplenia, HIV infection) or because they will be traveling to or residing in areas with hyperendemic or epidemic meningococcal disease.200,228 Primary immunization against meningococcal serogroups A, C, Y, and W-135 disease also is recommended in other adults at increased risk (e.g., health-care and laboratory personnel, military recruits).200,228

ACIP states that routine primary immunization against meningococcal serogroups A, C, Y, and W-135 disease is not recommended in adults who are not at increased risk for meningococcal disease.228

A 2-dose series of MenACWY vaccine is recommended for primary immunization in adults at increased risk for meningococcal infection.200,228 In addition, booster doses of MenACWY vaccine generally are recommended every 5 years in individuals who received primary immunization with MenACWY vaccine or the previously available unconjugated meningococcal vaccine (MPSV4; Menomune^®) and remain at prolonged increased risk.200,228

Although MenACWY-TT is labeled by FDA for use in adults of any age,1 MenACWY-D and MenACWY-CRM are both labeled by FDA for use in adults 19 through 55 years of age.108,152 However, ACIP states that MenACWY-D or MenACWY-CRM can be used in adults 56 years of age or older† for primary immunization or when booster doses are indicated in those at continued increased risk of meningococcal groups A, C, Y, and W-135 disease (e.g., those with certain chronic medical conditions, health-care and laboratory personnel, travelers).200,228

Individuals with Complement Deficiency, Properdin Deficiency, or Asplenia

Because individuals with persistent complement component deficiencies (e.g., inherited or chronic deficiencies in C3, C5-C9, properdin, factor D, factor H) or anatomic or functional asplenia (e.g., sickle cell disease) and those receiving treatment with a complement inhibitor (e.g., eculizumab, ravulizumab) are at increased risk for meningococcal disease,53,67,85,105,228,229,230 ACIP, AAP, and other experts recommend routine age-appropriate primary and booster immunization against meningococcal serogroups A, C, Y, and W-135 disease in these individuals.105,135,199,200,228 ACIP recommends that those who received primary immunization with MenACWY vaccine or the previously available unconjugated meningococcal vaccine (MPSV4; Menomune^®) generally should receive a booster dose of MenACWY vaccine every 5 years.228

If not previously vaccinated, patients scheduled to undergo elective splenectomy should be vaccinated against meningococcal disease at least 14 days prior to surgery whenever possible.134 If not administered before surgery, MenACWY vaccine should be administered as soon as possible after the procedure when the patient's condition is stable.134

HIV-infected Individuals

HIV-infected individuals are at increased risk for meningococcal disease, especially those with low CD4⁺ T-cell counts or high HIV viral loads.156,166,228 ACIP, AAP, and other experts recommend that all HIV-infected adults, adolescents, children, and infants 2 months of age or older receive routine age-appropriate primary and booster immunization against meningococcal serogroups A, C, Y, and W-135 using MenACWY vaccine.135,156,199,200

ACIP and other experts recommend that HIV-infected individuals immunized with MenACWY vaccine or the previously available unconjugated meningococcal vaccine (MPSV4; Menomune^®) should receive a booster dose of MenACWY vaccine every 5 years.105,156,200,228

Health-care and Laboratory Personnel

ACIP and Healthcare Infection Control Practices Advisory Committee (HICPAC) state that routine immunization against meningococcal serogroups A, C, Y, and W-135 disease is not recommended in health-care personnel.235 However, health-care personnel with certain chronic medical conditions that put them at increased risk of meningococcal disease (e.g., persistent complement component deficiencies, anatomic or functional asplenia, HIV infection) should receive a 2-dose primary immunization series of MenACWY vaccine.200,235 In addition, primary immunization with a single dose of the vaccine is recommended for laboratory personnel who may be routinely exposed to isolates of N. meningitidis 200,228,235 and for health-care personnel who will be traveling to areas where meningococcal disease is hyperendemic or epidemic.235

ACIP and HICPAC state that health-care and laboratory personnel who received primary immunization against meningococcal serogroups A, C, Y, and W-135 disease and remain at prolonged increased risk should receive a booster dose of MenACWY vaccine every 5 years.200,235

Regardless of vaccination status, postexposure anti-infective prophylaxis against meningococcal infection (i.e., 2-day regimen of oral rifampin or single dose of IM ceftriaxone, oral ciprofloxacin, or oral azithromycin) is recommended for all health-care personnel who have had unprotected (i.e., without wearing a mask) intensive contact (i.e., mouth-to-mouth resuscitation, endotracheal intubation or endotracheal tube management) with an infected patient.235

Military Recruits

Because the risk of meningococcal serogroups A, C, Y, and W-135 disease is increased among military recruits,228 all US military recruits routinely receive primary immunization with a single dose of MenACWY vaccine and should receive a booster dose of MenACWY every 5 years if at continued risk of exposure.200,228

Travelers

Travelers to or residents of areas where N. meningitidis is highly endemic or epidemic are at risk of exposure and should receive primary immunization against meningococcal serogroups A, C, Y, and W-135 disease.115,200,228 Although N. meningitidis is found worldwide, the highest incidence of meningococcal disease occurs in that portion of sub-Saharan Africa known as the “meningitis belt”.43,44,45,115,228 Meningococcal disease is hyperendemic in this region with epidemics occurring periodically during the dry season (i.e., December through June).115 Historically, serogroup A was the predominant cause of meningococcal disease outbreaks in the meningitis belt; however, endemic disease and outbreaks are now most commonly caused by serogroups C, W, and X.115,228

ACIP, AAP, CDC, and other experts recommend age-appropriate primary immunization against meningococcal serogroups A, C, Y, and W-135 disease with MenACWY vaccine prior to travel for individuals 2 months of age and older who will be traveling to or residing in hyperendemic or epidemic areas, including the meningitis belt of sub-Saharan Africa during the dry season (i.e., December through June), especially if prolonged contact with local populations is expected.115,199,200,228

ACIP recommends that international travelers who previously received primary immunization should receive a booster dose of MenACWY vaccine if 5 or more years have elapsed since the last dose of MenACWY or unconjugated meningococcal vaccine.228

The Hajj pilgrimage to Saudi Arabia has been associated with outbreaks of meningococcal disease in returning pilgrims and their contacts.115 Officials in Saudi Arabia require that individuals traveling to their country for the annual Hajj and Umrah pilgrimage have documentation indicating vaccination against meningococcal serogroups A, C, Y, and W-135 administered not less than 10 days and not more than 3 years (unconjugated polysaccharide vaccine) or not more than 5 years (conjugated polysaccharide vaccine) prior to arrival in Saudi Arabia.115

Advisories for US travelers are issued whenever epidemics of meningococcal disease caused by vaccine-preventable serogroups are reported in other countries.115,228 The most recent information concerning geographic areas for which vaccination against meningococcal disease is recommended can be obtained from international health clinics for travelers, state health departments, the CDC international travelers' hotline at 877-394-8747, or the CDC Travelers' Health website ([Web]).115,228

Household and Other Close Contacts of Individuals with Invasive Meningococcal Disease

Whenever a case of invasive meningococcal disease occurs, anti-infective prophylaxis (i.e., 2-day regimen of oral rifampin or single dose of IM ceftriaxone, oral ciprofloxacin, or oral azithromycin) is indicated for close contacts of the index case (i.e., household contacts; day-care center contacts; individuals exposed to the index case's oropharyngeal secretions through kissing, sharing toothbrushes or eating or drinking utensils, mouth-to-mouth resuscitation, endotracheal intubation or management).79,105,166,228 Anti-infective prophylaxis is the principal means of preventing secondary cases of meningococcal disease in contacts.79,90,228 Because protective levels of anticapsular antibodies are not achieved until 7-14 days following administration of MenACWY vaccine, vaccination cannot prevent early-onset disease in contacts and usually is not recommended following sporadic cases of invasive meningococcal disease.90,105

Outbreak Control

MenACWY vaccine may be recommended when an outbreak of meningococcal disease occurs in the US and the outbreak is caused by a N. meningitidis serogroup represented in the vaccine (i.e., serogroups A, C, Y, W-135).62,105,166,200,228

While the vast majority (95%) of cases of meningococcal disease in the US are sporadic, localized outbreaks of meningococcal disease do occur.62,71,166,228 Organization-based outbreaks of meningococcal disease can occur in childcare centers, elementary and junior high schools, colleges and universities, military recruit camps, and correctional institutions; community-based outbreaks have occurred in towns, cities, and counties and among men who have sex with men.62,105,228 An outbreak is defined as the occurrence of 2-3 outbreak-associated cases (e.g., cases caused by the same meningococcal serogroup) in an organization (e.g., school, college, correctional facility) during a 3-month period or multiple outbreak-associated cases with an incidence of meningococcal disease that is above the expected incidence in a community during a 3-month period.166 Recent meningococcal outbreaks in the US have been caused by serogroups B and C.166,228

Whenever sporadic or cluster cases or outbreaks of meningococcal disease occur in the US, anti-infective prophylaxis (i.e., 2-day regimen of oral rifampin or single dose of IM ceftriaxone, oral ciprofloxacin, or oral azithromycin) is the principal means of preventing secondary cases in household and other close contacts of individuals with invasive disease.105,166,228 Adjunctive use of MenACWY vaccine may be indicated in situations where there is an ongoing risk of exposure (e.g., when cluster cases or outbreaks occur) and when a meningococcal serogroup represented in the vaccine is involved.49,62,90,105,108

MenACWY vaccine does not stimulate immunity to meningococcal infection caused by serogroup B, and is not indicated when outbreaks are caused by meningococcal serogroup B.1,108,152,166,228

Dosage and Administration ⬆ ⬇

[Section Outline]

Reconstitution and Administration
Dosage

Reconstitution and Administration

Meningococcal (groups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine (MenACWY-D; Menactra^®),108 meningococcal (groups A, C, Y and W-135) oligosaccharide diphtheria CRM₁₉₇ conjugate vaccine (MenACWY-CRM; Menveo^®),152 and meningococcal (groups A, C, Y and W-135) polysaccharide tetanus toxoid conjugate vaccine (MenACWY-TT; MenQuadfi^®) are administered only by IM injection.1,108,152 These vaccines should not be administered subcutaneously, IV, or intradermally.108,152

Syncope (vasovagal or vasodepressor reaction; fainting) may occur following vaccination.1,108,134,152 Syncope occurs most frequently in adolescents and young adults.134 Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.1,134 Syncope and secondary injuries may be averted if vaccinees sit or lie down during and for 15 minutes after vaccination.134 If syncope occurs, the patient should be observed until symptoms resolve.134

MenACWY vaccine usually can be given concurrently with other age-appropriate vaccines;105,134,228 however, MenACWY-D should not be given concurrently with pneumococcal 13-valent conjugate vaccine (PCV13) in individuals with anatomic or functional asplenia (see Pneumococcal Vaccines under Drug Interactions).134,228

When multiple vaccines are administered during a single health-care visit, each parenteral vaccine should be given using separates syringes and different injection sites.108,134,152,228 Injection sites should be separated by at least 1 inch (if anatomically feasible) to allow appropriate attribution of any local adverse effects that may occur.134

IM Administration

Depending on patient age, IM injections should be made into the anterolateral muscles of the thigh or deltoid muscle of the arm.134

In infants younger than 12 months of age, IM injections should preferably be made into the anterolateral thigh.134 In certain circumstances (e.g., physical obstruction at other sites and no reasonable indication to defer the vaccine dose), IM injections can be made into the gluteal muscle using care to identify anatomical landmarks prior to injection.134

In infants and children 1 through 2 years of age, the anterolateral thigh is the preferred site for IM injections;134 alternatively, IM injections can be made into the deltoid muscle if muscle mass is adequate.134

In adults, adolescents, and children 3 years of age or older, IM injections should preferably be made into the deltoid muscle;134 alternatively, IM injections can be made into the anterolateral thigh.134

To ensure delivery into muscle, IM injections should be made at a 90° angle to the skin using a needle length appropriate for the individual's age and body mass, thickness of adipose tissue and muscle at the injection site, and injection technique.134,149,150 Anatomic variability, especially in the deltoid, should be considered and clinical judgment should be used to avoid inadvertent underpenetration or overpenetration of muscle.149,150

Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (MenACWY-D; Menactra®)

MenACWY-D is administered IM undiluted.108

MenACWY-D should be shaken well prior to use and should appear as a clear to slightly turbid liquid.108 The vaccine should be discarded if it contains particulate matter, appears discolored, or cannot be resuspended with thorough agitation.108

MenACWY-D should not be mixed with any other vaccine.108

Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (MenACWY-CRM; Menveo®)

MenACWY-CRM is supplied by the manufacturer as 2 components that must be combined prior to administration: a single-dose vial containing the meningococcal A conjugate component (MenA) in lyophilized form and a single-dose vial containing the meningococcal C, Y, and W-135 conjugate component (MenCYW-135) as a liquid.152 The entire contents of the vial containing the MenCYW-135 liquid component should be withdrawn into a syringe and injected into the vial containing the lyophilized MenA component.152 The vial should be inverted and shaken well until the vaccine is completely dissolved.152

Reconstituted MenACWY-CRM should be a clear, colorless solution and should not be used if it contains particulate matter or appears discolored.152

MenACWY-CRM should be administered IM immediately after reconstitution, but may be stored for up to 8 hours at 2-25°C.152 Prior to use, the vial of reconstituted MenACWY-CRM should be shaken well.152

MenACWY-CRM or its individual components should not be mixed with any other vaccine or diluent.152

Meningococcal (Groups A, C, Y and W-135) Polysaccharide Tetanus Toxoid Conjugate Vaccine (MenACWY-TT; MenQuadfi®)

MenACWY-TT is administered IM undiluted.1

MenACWY-TT should appear as a clear, colorless solution.1 The vaccine should be discarded if it contains particulate matter or appears discolored.1

Dosage

The dosage schedule (i.e., number and timing of doses for primary immunization) and specific MenACWY vaccine administered (MenACWY-D, MenACWY-CRM, MenACWY-TT) depend on the individual's age, immunization status, and risk factors.1,108,152,199,228 The age-appropriate recommendations for the specific preparation used should be followed. 108,152,228

ACIP states that MenACWY-D, MenACWY-CRM, and MenACWY-TT can be used interchangeably, including use in an age-appropriate multiple-dose primary immunization series or for booster doses after primary immunization.134,228 ACIP states that if the same MenACWY vaccine used previously is not available or not known, any age-appropriate MenACWY vaccine can be administered for subsequent doses.134

If interruptions or delays result in an interval between vaccine doses longer than recommended, ACIP states that it is not necessary to administer additional doses or start the vaccination series over.134

Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (MenACWY-D; Menactra®)

MenACWY-D is administered IM in 0.5-mL doses.108

MenACWY-D is labeled by FDA for use in individuals 9 months through 55 years of age.108

Although safety and efficacy of MenACWY-D have not been established in adults 56 years of age or older†,152 ACIP states that the vaccine can be used when primary immunization or booster doses are indicated in this age group.200,228

Infants 9 through 23 Months of Age

Primary immunization with MenACWY-D in infants 9 through 23 months of age at increased risk for meningococcal serogroups A, C, Y, and W-135 disease because of certain chronic medical conditions or treatment (see Uses) or travel to areas with hyperendemic or epidemic meningococcal disease: The manufacturer, ACIP, AAP, and other experts recommend that 2 doses of MenACWY-D be administered 3 months apart (minimum 12 weeks apart).105,108,199,228 If necessary (e.g., before travel), the doses may be given 2 months (8 weeks) apart.105,199

Booster doses in those who remain at prolonged increased risk for meningococcal disease: ACIP and AAP recommend a booster dose of MenACWY vaccine at 3 years after completion of the primary immunization series and every 5 years thereafter.105,199,228

Children 2 through 10 Years of Age

Primary immunization in children 2 through 10 years of age at increased risk for meningococcal serogroups A, C, Y, and W-135 disease because of certain chronic medical conditions or treatment (see Uses): ACIP, AAP, and other experts recommend that 2 doses of MenACWY-D be administered 2 months apart (minimum 8 weeks apart).105,199,228 The manufacturer states that a single dose of MenACWY-D can be used for primary immunization.108

Primary immunization in children 2 through 10 years of age at increased risk for meningococcal serogroups A, C, Y, and W-135 disease because they are travelers to or residents of areas with hyperendemic or epidemic meningococcal disease: ACIP and AAP recommend a single dose of MenACWY vaccine.105,228

Booster doses in those who remain at prolonged increased risk for meningococcal disease: ACIP and AAP recommend that children who received primary immunization at 2 through 6 years of age should receive a booster dose of MenACWY vaccine at 3 years after completion of the primary immunization series and every 5 years thereafter.105,228 Those who received primary immunization at 7 years of age or older should receive a booster dose of MenACWY vaccine at 5 years after completion of the primary immunization series and every 5 years thereafter.105,228

Adolescents 11 through 18 Years of Age

Routine primary immunization against meningococcal serogroups A, C, Y, and W-135 disease and booster dose in adolescents: ACIP, AAP, and other experts recommend that a primary dose of MenACWY vaccine be given at 11 through 12 years of age, followed by a booster dose at 16 years of age.105,199,228

Catch-up vaccination with MenACWY vaccine is recommended at the first opportunity for all adolescents 13 through 18 years of age who were not vaccinated at 11 through 12 years of age.105,199,228 Adolescents who receive their first dose of MenACWY vaccine at 13 through 15 years of age should receive a booster dose at 16 through 18 years of age given at least 8 weeks after the first dose.199,228 A booster dose is not needed if the first dose was given at 16 years of age or older.199,228

Primary immunization in adolescents 11 through 18 years of age at increased risk for meningococcal serogroups A, C, Y, and W-135 disease because of certain chronic medical conditions or treatment (see Uses): ACIP, AAP, and other experts recommend that 2 doses of MenACWY-D be administered 2-3 months apart (minimum 8 weeks apart).105,199,228 The manufacturer states that a single dose of MenACWY-D can be used for primary immunization.108

Booster doses in those who remain at increased risk for meningococcal disease: ACIP and other experts recommend a booster dose of MenACWY vaccine every 5 years.200,228 The manufacturer states that a booster dose of MenACWY-D vaccine may be given if it has been at least 4 years since the prior dose.108

Adults 19 Years of Age or Older

Primary immunization in adults 19 through 55 years of age at increased risk for meningococcal serogroups A, C, Y, and W-135 disease because of certain chronic medical conditions or treatment (see Uses): ACIP, AAP, and other experts recommend that 2 doses of MenACWY-D be administered 2-3 months apart (minimum 8 weeks apart).200,228 The manufacturer states that a single dose of MenACWY-D can be used for primary immunization.108

Primary immunization in adults 19 through 55 years of age at increased risk for meningococcal serogroups A, C, Y, and W-135 disease because they are health-care or laboratory personnel, military recruits, or travelers to or residents of areas with hyperendemic or epidemic meningococcal disease: ACIP and other experts recommend a single dose of MenACWY vaccine.200,228

Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (MenACWY-CRM; Menveo®)

MenACWY-CRM is administered IM in 0.5-mL doses.152

MenACWY-CRM is labeled by FDA for use in individuals 2 months through 55 years of age.152

Although safety and efficacy of MenACWY-CRM have not been established in adults 56 years of age or older†,152 ACIP states that the vaccine can be used when primary immunization or booster doses are indicated in this age group.200,228

Infants 2 through 23 Months of Age

Primary immunization initiated in infants 2 months of age at increased risk for meningococcal serogroups A, C, Y, and W-135 disease because of certain chronic medical conditions or treatment (see Uses) or travel to areas with hyperendemic or epidemic meningococcal disease: MenACWY-CRM is given in a series of 4 doses.152,199 The doses should be given at 2, 4, 6, and 12 months of age.152,199

Primary immunization initiated in previously unvaccinated infants 7 through 23 months of age at increased risk for meningococcal serogroups A, C, Y, and W-135 disease because of certain chronic medical conditions or treatment (see Uses) or travel to areas with hyperendemic or epidemic meningococcal disease: MenACWY-CRM is given in a 2-dose regimen.152,199 The second dose should be administered after the first birthday and at least 3 months (12 weeks) after the first dose.152,199

Children 2 through 10 Years of Age

Primary immunization in children 2 through 10 years of age at increased risk for meningococcal serogroups A, C, Y, and W-135 disease because of certain chronic medical conditions or treatment (see Uses): ACIP, AAP, and other experts recommend that 2 doses of MenACWY-CRM be administered 2 months apart (minimum 8 weeks apart).105,199,228 The manufacturer states that a single dose of MenACWY-CRM can be used for primary immunization and states that those 2-5 years of age at continued high risk can receive a second dose of the vaccine administered 2 months after the first dose.152

Primary immunization in children 2 through 10 years of age at increased risk for meningococcal disease because they are travelers to or residents of areas with hyperendemic or epidemic meningococcal disease: ACIP and AAP recommend a single dose of MenACWY vaccine.105,228

Adolescents 11 through 18 Years of Age

Primary immunization in adolescents 11 through 18 years of age at increased risk for meningococcal serogroups A, C, Y, and W-135 disease because of certain chronic medical conditions or treatment (see Uses): ACIP, AAP, and other experts recommend that 2 doses of MenACWY-CRM be administered 2-3 months apart (minimum 8 weeks apart).105,199,228 The manufacturer states that a single dose of MenACWY-CRM can be used for primary immunization.152

Booster doses in those who remain at prolonged increased risk for meningococcal disease: ACIP and other experts recommend a booster dose of MenACWY vaccine every 5 years.200,228 The manufacturer states that a booster dose of MenACWY-CRM may be given if it has been at least 4 years since the prior dose.152

Adults 19 Years of Age or Older

Primary immunization in adults at increased risk for meningococcal serogroups A, C, Y, and W-135 disease because of certain chronic medical conditions or treatment (see Uses): ACIP, AAP, and other experts recommend 2 doses of MenACWY-CRM administered 2-3 months apart (minimum 8 weeks apart).200,228 The manufacturer states that a single dose of MenACWY-CRM can be used for primary immunization.152

Booster doses in adults who remain at prolonged increased risk for meningococcal disease: ACIP and other experts recommend a booster dose of MenACWY vaccine every 5 years.200,228 The manufacturer states that a booster dose of MenACWY-CRM may be given if it has been at least 4 years since the prior dose.152

Meningococcal (Groups A, C, Y and W-135) Polysaccharide Tetanus Toxoid Conjugate Vaccine (MenACWY-TT; MenQuadfi®)

MenACWY-TT is administered IM in 0.5-mL doses.1

MenACWY-TT is labeled by FDA for use in individuals 2 years of age or older.1

Children 2 through 10 Years of Age

Primary immunization in children 2 through 10 years of age at increased risk for meningococcal serogroups A, C, Y, and W-135 disease because of certain chronic medical conditions or treatment (see Uses): ACIP, AAP, and other experts recommend that 2 doses of MenACWY-TT be administered 2 months apart (minimum 8 weeks apart).199,228 The manufacturer states that a single dose of MenACWY-TT can be used for primary immunization.1

Adolescents 11 through 18 Years of Age

Primary immunization in adolescents 11 through 18 years of age at increased risk for meningococcal serogroups A, C, Y, and W-135 disease because of certain chronic medical conditions or treatment (see Uses): ACIP, AAP, and other experts recommend that 2 doses of MenACWY-TT be administered 2-3 months apart (minimum 8 weeks apart).199,228 The manufacturer states that a single dose of MenACWY-TT can be used for primary immunization.1

Booster doses in those who remain at prolonged increased risk for meningococcal disease: ACIP and other experts recommend a booster dose of MenACWY vaccine every 5 years.200,228 The manufacturer states that a booster dose of MenACWY-TT may be given to those 15 years of age or older if it has been at least 4 years since the prior dose.1

Adults 19 Years of Age or Older

Primary immunization in adults 19 years of age and older at increased risk for meningococcal serogroups A, C, Y, and W-135 disease because of certain chronic medical conditions or treatment (see Uses): ACIP, AAP, and other experts recommend that 2 doses of MenACWY-TT be administered 2-3 months apart (minimum 8 weeks apart).200,228 The manufacturer states that a single dose of MenACWY-TT can be used for primary immunization.1

Primary immunization in adults 19 years of age and older at increased risk for meningococcal serogroups A, C, Y, and W-135 disease because they are health-care or laboratory personnel, military recruits, or travelers to or residents of areas with hyperendemic or epidemic meningococcal disease: ACIP and other experts recommend a single dose of MenACWY vaccine.200,228

Booster doses in adults who remain at prolonged increased risk for meningococcal disease: ACIP and other experts recommend a booster dose of MenACWY vaccine every 5 years.200,228 The manufacturer states that a booster dose of MenACWY-TT may be given if it has been at least 4 years since the prior dose.1

Cautions ⬆ ⬇

[Section Outline]

Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (MenACWY-D; Menactra®)
Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (MenACWY-CRM; Menveo®)
Meningococcal (Groups A, C, Y and W-135) Polysaccharide Tetanus Toxoid Conjugate Vaccine (MenACWY-TT; MenQuadfi®)
Precautions and Contraindications
Pediatric Precautions
Geriatric Precautions
Mutagenicity and Carcinogenicity
Pregnancy, Fertility, and Lactation

Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (MenACWY-D; Menactra®)

Information on the safety of meningococcal (groups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine (MenACWY-D) has been obtained principally from 8 clinical studies in which 10,057 individuals 2-55 years of age received the vaccine.108 In the 3 primary safety studies, individuals were randomized to receive MenACWY-D or unconjugated meningococcal polysaccharide vaccine, groups A, C, Y and W-135 combined (MPSV4; no longer available in the US).108 In 2 of the safety studies, MenACWY-D was administered concurrently with typhoid Vi polysaccharide vaccine or with tetanus and diphtheria toxoids adsorbed (Td).108

Adverse effects reported most frequently when MenACWY-D was used in children 2 through 10 years of age were local effects at the injection site (e.g., pain) and irritability.108 Diarrhea, drowsiness, and anorexia were also common in this age group.108

The most common adverse effects reported in adolescents and adults 11 through 55 years of age following a single dose of MenACWY-D were local effects at the site of injection (e.g., pain), headache, and fatigue.108

Local Effects

Adverse local effects, including pain,108 induration,108 erythema,108 and swelling,108 have been reported in 17-45% of children 2 through 10 years of age, 11-59% of adolescents 11 through 18 years of age, and 13-54% of adults 19 through 55 years of age who received MenACWY-D.108

Systemic Effects

The most frequently reported systemic adverse effects in children 2 through 10 years of age who received MenACWY-D were irritability, diarrhea, drowsiness, anorexia, arthralgia, fever, vomiting, and rash.108 While irritability, drowsiness, and diarrhea were reported in 11-12% of these children, arthralgia, fever, vomiting, and rash were reported in 3-8%.108 The most frequently reported systemic effects in adolescents and adults 11 through 55 years of age following a single dose of MenACWY-D were headache,108 fatigue,108 malaise,108 arthralgia,108 diarrhea,108 anorexia,108 chills,108 fever,108 vomiting,108 and rash.108 While headache, fatigue, malaise, and arthralgia were reported in 17-41%, GI effects, chills, fever, and rash were reported in only 1-16%.108

In clinical studies comparing safety and efficacy of MenACWY-D in children, adolescents, and adults 2 through 55 years of age, fever (39.5°C or higher) was reported in 5% of adolescents who received MenACWY-D.108 The overall rate of severe systemic adverse effects reported within 6 months of vaccination was about 1% in adolescents and adults and was less than 1% in children 2 through 10 years of age following administration of the conjugated meningococcal vaccine.108

Although a causal relationship to MenACWY-D has not been established, vasovagal syncope, facial palsy, transverse myelitis, acute disseminated encephalomyelitis, myalgia, and lymphadenopathy have been reported during postmarketing surveillance.108

Hypersensitivity reactions (e.g., anaphylactic/anaphylactoid reaction, wheezing, difficulty breathing, upper airway swelling, urticaria, erythema, pruritus, hypotension, erythema multiforme) have been reported rarely in patients who received MenACWY-D.108,146

Guillain-Barré Syndrome

There have been postmarketing reports of Guillain-Barré syndrome (GBS) temporally associated with administration of MenACWY-D.108,110,111,122,123,124,238 Reported cases of GBS generally involved individuals 11 through 19 years of age at the time of vaccination with onset of symptoms within 6 weeks of the vaccine dose.110,122,123,124 One individual had experienced previous episodes of GBS at 2 and 5 years of age after receiving routine childhood vaccinations and another had no personal history of GBS but had a mother with a history of GBS.110

GBS is a serious neurologic disorder involving inflammatory demyelination of peripheral nerves and may occur spontaneously or after certain antecedent events such as infections.110,111 The disorder is characterized by subacute onset of progressive, symmetrical weakness in the legs and arms, with loss of reflexes.110 Sensory abnormalities, cranial nerve involvement, and paralysis of respiratory muscles may also develop.110 GBS is sometimes fatal and 20% of hospitalized patients may have prolonged disability.110

Because of these initial reports, FDA, the US Centers for Disease Control and Prevention (CDC), and others began investigating the possible relationship between administration of MenACWY-D and the occurrence of GBS.110,111,122,123,124,238 In one postmarketing retrospective safety study that evaluated the risk of GBS following administration of MenACWY-D, claims data from over 9 million individuals 11 through 18 years of age was analyzed (15% of these individuals had received the vaccine).108 Based on 72 chart-confirmed cases of GBS in this population, none had received MenACWY-D within 42 days of symptom onset.108 An additional 129 potential cases of GBS could not be confirmed or excluded using chart review.108 An analysis taking into account the missing data estimated that the attributable risk of GBS ranged from 0-5 additional cases per 1 million vaccinees within the 6-week period following vaccination.108 In another retrospective, cohort study involving 12.6 million individuals 11-21 years of age, more than 1.4 million doses of MenACWY-D had been administered and there were 99 confirmed cases of GBS (5.4 cases per 1 million vaccinees); none of these occurred within 6 weeks following vaccination.238 (See Precautions and Contraindications under Cautions.)

Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (MenACWY-CRM; Menveo®)

Information on the safety of meningococcal (groups A, C, Y and W-135) oligosaccharide diphtheria CRM₁₉₇ conjugate vaccine (MenACWY-CRM) has been obtained from clinical studies in infants 2 through 23 months of age, children 2 through 10 years of age, and adolescents and adults 11 through 55 years of age.152 In 4 safety studies conducted in children 2 through 10 years of age, individuals were randomized to receive MenACWY-CRM or a comparator vaccine (MenACWY-D or MPSV4 [no longer available in the US]).152 In 5 safety studies in adolescents and adults 11 through 55 years of age, 5286 individuals received MenACWY-CRM alone, 899 individuals received MenACWY-CRM concomitantly with other vaccines (i.e., tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed [Tdap; Boostrix^®] with or without human papillomavirus 4-valent vaccine recombinant [4vHPV; no longer available in the US]). The remaining individuals were randomized to receive a comparator vaccine (MenACWY-D or MPSV4 [no longer available in the US).152

Adverse effects reported most frequently in infants 2 through 23 months of age who received a 4-dose regimen of MenACWY-CRM administered concurrently with other routine infant vaccines were tenderness (24-41%) and erythema (11-15%) at the injection site, irritability (42-57%), sleepiness (29-50%), persistent crying (21-41%), change in eating habits (17-23%), vomiting (5-11%), and diarrhea (8-16%).152 The rates of solicited local and systemic adverse effects in these infants were comparable to rates among those who received the routine infant vaccines without MenACWY-CRM.152

Adverse effects reported most frequently when MenACWY-CRM was used in children 2 through 10 years of age were injection site pain (31%), erythema (23%), irritability (18%), induration (16%), sleepiness (14%), malaise (12%), and headache (11%).152

Among adolescents and adults 11 through 55 years of age, the most frequently reported adverse effects were injection site pain (41%), headache (30%), myalgia (18%), malaise (16%), and nausea (10%).152

Local Effects

Adverse local effects (pain, erythema, induration) were reported in 18-33% of children 2 through 5 years of age, 17-39% of children 6 through 10 years of age, 12-44% of adolescents 11 through 18 years of age, and 13-38% of adults 19 through 55 years of age who received a single dose of MenACWY-CRM.152 These local effects were considered moderate in 2-8% and severe in up to 1% of children 2 through 10 years of age, and were considered moderate in 1-9% and severe in up to 1% of individuals 11 through 55 years of age.152

Systemic Effects

Adverse systemic effects, including irritability, sleepiness, change in eating, diarrhea, headache, rash, arthralgia, vomiting, and fever, have been reported in children 2 through 5 years of age who received a single dose of MenACWY-CRM in clinical studies.152 While irritability, sleepiness, and change in eating were reported in 9-21% of these children, diarrhea, headache, rash, arthralgia, vomiting, and fever occurred in 2-7%.152

In children 6 through 10 years of age who received a single dose of MenACWY-CRM in clinical studies, headache, malaise, myalgia, nausea, arthralgia, chills, rash, and fever have been reported.152 While headache, malaise, and myalgia were reported in 10-18% of these children, nausea, arthralgia, chills, rash, and fever were reported in 2-8%.152

The most frequently reported systemic effects in adolescents and adults 11 through 55 years of age who received a single dose of MenACWY-CRM in clinical studies were headache, myalgia, nausea, malaise, chills, arthralgia, rash, and fever.152 While headache, myalgia, nausea, and malaise were reported in 11-29% of adolescents 11 through 18 years of age, chills, arthralgia, rash, and fever were reported in 1-8% of these adolescents.152 Headache, myalgia, and malaise were reported in 10-25% and nausea, arthralgia, chills, rash, and fever were reported in 1-7% of adults 19 through 55 years of age who received a single dose of MenACWY-CRM.152

There have been postmarketing reports of Bell's palsy in temporal association with administration of a dose of MenACWY-CRM in adolescents and young adults 11-21 years of age.152,239 Symptoms of Bell's palsy resolved in all reported cases to date.152 In 6 of 8 cases that occurred within 84 days after vaccination, MenACWY-CRM had been administered concomitantly with at least 1 other vaccine (i.e., HPV vaccine, Tdap, influenza vaccine).152,239

Ear and eye disorders (e.g., impaired hearing, ear pain, vertigo, vestibular disorder, eyelid ptosis), vaccination site cellulitis, nervous system disorders (e.g., dizziness, syncope, tonic convulsions, facial paresis, balance disorder), oropharyngeal pain, arthralgia, bone pain, and skin exfoliation have been reported during postmarketing surveillance.152 A causal relationship to MenACWY-CRM has not been established.152

Hypersensitivity reactions have been reported in patients who received MenACWY-CRM.152

Meningococcal (Groups A, C, Y and W-135) Polysaccharide Tetanus Toxoid Conjugate Vaccine (MenACWY-TT; MenQuadfi®)

Information on the safety of meningococcal (groups A, C, Y and W-135) polysaccharide tetanus toxoid conjugate vaccine (MenACWY-TT) has been obtained from clinical studies in children 2 through 9 years of age, adolescents 10 through 17 years of age, and adults 18 years of age and older.1 In one safety study conducted in children 2 through 9 years of age, individuals were randomized to receive MenACWY-TT or a comparator vaccine (MenACWY-CRM).1 In 2 safety studies in adolescents 10 through 17 years of age, 1684 individuals received MenACWY-TT alone, 392 received MenACWY-TT concomitantly with other vaccines (i.e., tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed [Tdap; Boostrix^®] and human papillomavirus 4-valent vaccine recombinant [4vHPV; no longer available in the US]) and 824 individuals were randomized to receive a comparator vaccine (MenACWY-D or MenACWY-CRM).1

In children 2 through 9 years of age, the most common adverse effects of MenACWY-TT following a primary dose were pain (39%), erythema (23%), and swelling (14%) at the injection site, myalgia (21%), malaise (20%), and headache (13%).1

In adolescents 10 through 17 years of age, the most common adverse effects of MenACWY-TT following a primary dose were injection site pain (35-45%), myalgia (27-35%), headache (27-30%), and malaise (19-26%).1

In adults 18 through 55 years of age, the most common adverse effects of MenACWY-TT following a primary dose were injection site pain (42%), myalgia (36%), headache (29%), and malaise (15%).1

In adults 56 years of age or older, the most common adverse effects of MenACWY-TT following a primary dose were injection site pain (26%), myalgia (22%), headache (19%), and malaise (15%).1

Adverse effects reported following a booster dose of MenACWY-TT in adolescents and adults were comparable to those reported following primary immunization.1

Precautions and Contraindications

Prior to administration of MenACWY vaccine all known precautions should be taken to prevent adverse reactions, including a review of the patient's history with respect to health status and possible sensitivity to the vaccine, similar vaccines, or vaccine components.108 Epinephrine and other appropriate agents and equipment should be available for immediate treatment if an anaphylactic or other serious allergic reaction occurs.1,108,152

The patient and/or the patient's parent or guardian should be informed of the benefits and risks of immunization with MenACWY and should be provided with a copy of the appropriate Vaccine Information Statement (available at CDC website at [Web]).1,108,120,152 Patients and/or the patient's parent or guardian also should be instructed to report any severe or unusual adverse reactions to their healthcare provider.1,108,152 Clinicians or individuals can report any adverse reactions that occur following vaccination to VAERS at 800-822-7967 or [Web].108,1,152

Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (MenACWY-D; Menactra®)

MenACWY-D is contraindicated in individuals with a history of severe allergic reaction (e.g., anaphylaxis) after a previous dose of the vaccine, any vaccine component, or any vaccine containing meningococcal capsular polysaccharide, diphtheria toxoid, or diphtheria CRM₁₉₇.108

Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (MenACWY-CRM; Menveo®)

MenACWY-CRM is contraindicated in individuals with a history of severe allergic reaction (e.g., anaphylaxis) after a previous dose of the vaccine or any vaccine containing meningococcal antigens, diphtheria toxoid, or diphtheria CRM₁₉₇.152

Meningococcal (Groups A, C, Y and W-135) Polysaccharide Tetanus Toxoid Conjugate Vaccine (MenACWY-TT; MenQuadfi®)

MenACWY-TT is contraindicated in individuals with a history of severe allergic reaction to any component of the vaccine or after a previous dose of the vaccine or any vaccine containing tetanus toxoid.1

Individuals with Altered Immunocompetence

Like other inactivated vaccines, MenACWY vaccine may be administered to individuals immunosuppressed as a result of disease or medical therapy;105,134,135,228 however, immune responses to vaccines and efficacy may be reduced in individuals with altered immunocompetence.1,105,108,134,135,152,228

ACIP, AAP, and other experts recommend that adults, adolescents, children, and infants 2 months of age or older with human immunodeficiency virus (HIV) infection receive age-appropriate MenACWY vaccine for primary and booster immunization against meningococcal serogroups A, C, Y, and W-135 infection.105,135,156

Individuals with functional or anatomic asplenia (including sickle cell disease) are at increased risk for meningococcal disease and should receive age-appropriate immunization against meningococcal serogroups A, C, Y, and W-135.105,134,135 When planning immunization against meningococcal disease and pneumococcal disease in infants and children with anatomic or functional asplenia, clinicians should consider that MenACWY-D should not be administered concomitantly with or within 4 weeks after pneumococcal 13-valent conjugate vaccine (PCV13) (see Pneumococcal Vaccines under Drug Interactions).134,228

In patients scheduled for elective splenectomy, MenACWY vaccine should be administered at least 14 days prior to surgery;105,134,228 if not administered prior to surgery, MenACWY vaccine should be administered as soon as possible following the procedure when the patient's condition is stable.105,134,228

Individuals with persistent complement component deficiency and those receiving treatment with a complement inhibitor (e.g., eculizumab, ravulizumab) are at increased risk for invasive disease caused by meningococcal serogroups A, C, Y, and W-135, even if they develop antibodies following vaccination with MenACWY vaccine.1,108,152,229,230 Because life-threatening and fatal meningococcal infections have occurred in patients receiving eculizumab or ravulizumab, meningococcal vaccines should be administered at least 2 weeks prior to the first dose of eculizumab or ravulizumab, unless the risks of delaying initiation of the drug outweigh the risks of meningococcal infection.229,230

Inactivated vaccines generally should be administered prior to initiation of immunosuppressive therapy or deferred until immunosuppressive therapy is discontinued.105,134 (See Immunosuppressive Agents under Drug Interactions.)

Concomitant Illness

A decision to administer or delay vaccination in an individual with a current or recent acute illness depends on the severity of symptoms and etiology of the illness.134

ACIP states that mild acute illness generally does not preclude vaccination.134 However, moderate or severe acute illness (with or without fever) is a precaution for vaccination and vaccines should be deferred until the individual has recovered from the acute phase of the illness.134 This precaution avoids superimposing adverse effects of the vaccine on the underlying illness or mistakenly concluding that a manifestation of the underlying illness resulted from vaccination.134

Guillain-Barré Syndrome

Because there have been postmarketing reports of GBS temporally associated with MenACWY-D,108,110,111,122,123,124,238 the manufacturer states that individuals with a history of GBS may be at increased risk of GBS following administration of the vaccine and the decision to administer MenACWY-D in such individuals should take into account the potential benefits and risks of immunization.108

The manufacturers of MenACWY-CRM and MenACWY-TT state that, because GBS has been reported in temporal relationship following administration of another US quadrivalent polysaccharide meningococcal conjugate vaccine, a decision to administer MenACWY-CRM or MenACWY-TT in an individual with a history of GBS should take into account the potential benefits and risks.1,152

After reviewing available safety data regarding MenACWY vaccines, ACIP concluded that the benefits of vaccination against meningococcal serogroups A, C, Y, and W-135 outweigh the potential increased risk for GBS.228 ACIP states that, although early postmarketing surveillance raised the concern of a potential risk for GBS, subsequent evaluations have not identified an increased risk for GBS after MenACWY-D vaccination.228

Individuals with Bleeding Disorders

Individuals who have bleeding disorders or are receiving anticoagulant therapy and/or their family members should be advised about the risk of hematoma from IM injections.134

ACIP states that IM vaccines may be given to individuals who have bleeding disorders or are receiving anticoagulant therapy if a clinician familiar with the patient's bleeding risk determines that the vaccine can be administered IM with reasonable safety.134 In these cases, a fine needle (23 gauge or smaller) should be used to administer the vaccine and firm pressure should be applied to the injection site (without rubbing) for at least 2 minutes.134 In individuals receiving therapy for hemophilia, IM vaccines can be scheduled for shortly after a dose of such therapy.134

Limitations of Vaccine Effectiveness

MenACWY vaccine may not protect all vaccine recipients against meningococcal serogroups A, C, Y, and W-135 infection.1,105,108 In addition, the quadrivalent meningococcal vaccines provide protection only against those serogroups represented in the vaccine (i.e., groups A, C, Y, W-135).1,105,108,152,228 MenACWY vaccine will not prevent meningococcal infection caused by N. meningitidis serogroups not represented in the vaccine (e.g., serogroup B) and will not prevent infections caused by other pathogens.1,105,108,152,228

Although MenACWY-TT contains meningococcal antigens conjugated to tetanus toxoid, the vaccine is not a substitute for routine immunization against tetanus.1

Duration of Immunity

Duration of protection following primary immunization with conjugated MenACWY vaccine (MenACWY-D, MenACWY-CRM, MenACWY-TT) or the previously available unconjugated meningococcal vaccine (MPSV4; Menomune^®) has not been fully determined.105,108,152,228

Meningococcal antigens in MenACWY-D, MenACWY-CRM, or MenACWY-TT are conjugated to a diphtheria toxoid, CRM₁₉₇ protein carrier, or tetanus toxoid, respectively.1,108,152,228 These T-cell epitopes may result in an improved primary response to the meningococcal antigens and a strong anamnestic response after re-exposure to the antigens.108,134,228 The conjugated MenACWY vaccines are expected to provide a longer duration of protection than the previously available unconjugated meningococcal vaccine.228

Booster doses of MenACWY vaccine may be necessary in individuals who previously received MenACWY vaccine or unconjugated MPSV4 vaccine and continue to be at prolonged increased risk of exposure to meningococcal infection.105,166,199,200,228 This includes individuals with increased susceptibility because of certain chronic medical conditions or treatment (e.g., complement component deficiencies, treatment with a complement inhibitor, anatomic or functional asplenia, HIV infection) and those who have prolonged exposure (e.g., microbiologists routinely working with N. meningitidis , travelers to or residents of areas where meningococcal disease is hyperendemic or epidemic).1,105,135,166,199,200,228

Improper Storage and Handling

Improper storage or handling of vaccines may reduce vaccine potency resulting in reduced or inadequate immune response in vaccinees.134

All vaccines should be inspected upon delivery and monitored during storage to ensure that the appropriate temperature is maintained.134 (See Stability under Chemistry and Stability.)

Meningococcal vaccine that has been mishandled or has not been stored at the recommended temperature should not be administered.134

If there are concerns about mishandling, the manufacturer or state or local immunization or health departments should be contacted for guidance on whether the vaccine is usable.134

Pediatric Precautions

MenACWY-D: Safety and efficacy have not been established in children younger than 9 months of age.108

MenACWY-CRM: Safety and efficacy have not been established in children younger than 2 months of age.152

MenACWY-TT: Safety and efficacy have not been established in children younger than 2 years of age.1

Apnea has been reported following IM administration of vaccines in some infants born prematurely.152 Decisions regarding when to administer an IM vaccine in infants born prematurely should be based on consideration of the individual infant's medical status and potential benefits and possible risks of vaccination.152

Geriatric Precautions

MenACWY-D and MenACWY-CRM: Safety and efficacy have not been established in adults 56 years of age or older†, including geriatric adults 65 years of age or older.108,152 However, ACIP states that these MenACWY vaccines can be used when indicated in this age group.228

MenACWY-TT: A clinical study in adults 56 years of age or older included 199 vaccinees 56 through 64 years of age and 249 vaccinees 65 years of age or older (71 of these were 75 years of age or older).1 The antibody response to all MenACWY vaccine serotypes was diminished in vaccine recipients 65 years of age or older compared with recipients 56 through 64 years of age.1

Mutagenicity and Carcinogenicity

The mutagenic and carcinogenic potential of MenACWY vaccine (MenACWY-D, MenACWY-CRM, MenACWY-TT) has not been evaluated.1,108,152

Pregnancy, Fertility, and Lactation

Pregnancy

There are no adequate and well-controlled studies evaluating MenACWY vaccine (MenACWY-D, MenACWY-CRM, MenACWY-TT) in pregnant women.1,108,152

MenACWY-D: Available data suggest that rates of major birth defects and miscarriage in women who received the vaccine 30 days prior to pregnancy or during pregnancy are consistent with estimated background rates.108 Animal reproduction studies performed in pregnant mice using 0.1 mL of the vaccine administered 14 days prior to mating and on days 6 and 18 of gestation did not reveal any vaccine-related fetal malformations or variations and no adverse effects on postnatal development.108 Clinicians are encouraged to report any exposure to MenACWY-D that occurs during pregnancy to the manufacturer's vaccination pregnancy registry at 800-822-2463.108

MenACWY-CRM: Animal reproduction studies performed in female rabbits using a dosage of the vaccine approximately 20 times the human dose (calculated on a mg/kg basis) did not reveal evidence of harm to the fetus.152 Data for 82 women enrolled in a pregnancy registry from 2014-2017 do not suggest an increased risk of major birth defects or miscarriage in women who received the vaccine within 28 days prior to conception or during pregnancy.152

MenACWY-TT: Animal reproduction studies performed in female rabbits using 0.5 mL of the vaccine administered 30 and 10 days prior to mating and on days 6, 12, and 27 of gestation did not reveal evidence of harm to the fetus or adverse effects on postnatal development.1 Clinicians are encouraged to report any exposure to MenACWY-TT that occurs during pregnancy to the manufacturer's pregnancy registry at 800-822-2463.1

ACIP and AAP state that MenACWY vaccine may be used during pregnancy if indicated.105,228 ACIP states that, although data are limited, postmarketing surveillance has not identified any concerning safety signals regarding use of MenACWY vaccines during pregnancy.228

Analysis of anticapsular antibody levels in maternal and cord blood samples obtained at the time of delivery from women who received unconjugated capsular polysaccharide antigens from N. meningitidis serogroups A and C (not commercially available in the US) indicate that pregnant women have a good antibody response to antigens from both serogroup A and C, and these antibodies cross the placenta.12,64,65,74 The extent of placental transfer of group A and C antibodies shows considerable interindividual variation;12,14,18,64,65,74 the ratio of cord blood anticapsular antibody levels to maternal anticapsular antibody levels has ranged from 0.1-1.1 (mean: 0.3-0.6).64,65,74 Levels of maternal group A and C antibodies in the child decline over the first few months after birth; by 4-8 months of age, children born to mothers who were vaccinated during pregnancy have anticapsular antibody levels similar to those in children born to unvaccinated mothers.64,74 There was no evidence that administration of bivalent meningococcal vaccines containing capsular polysaccharide antigens from serogroups A and C to pregnant women had any effect on the antibody response in the child following subsequent vaccination with a meningococcal polysaccharide vaccine.64

Fertility

MenACWY-D: Animal reproduction studies performed in pregnant mice did not reveal any effects on fertility.108

MenACWY-CRM: Animal reproduction studies performed in rabbits using a dose of the vaccine approximately 20 times the human dose (calculated on a mg/kg basis) did not reveal any evidence of impaired fertility.152

MenACWY-TT: Animal reproduction studies performed in female rabbits did not reveal any effects on fertility.1

Lactation

It is not known whether antigens contained in MenACWY vaccine are distributed into milk.1,108,152

The manufacturers state that the benefits of breast-feeding and the importance of MenACWY vaccine to the woman should be considered along with the potential adverse effects on the breast-fed child from the vaccine or from the underlying maternal condition (i.e., susceptibility to meningococcal infection).1,108,152

ACIP states that breast-feeding women should receive MenACWY vaccine if indicated.228

Drug Interactions ⬆ ⬇

[Section Outline]

Immune Globulins
Immunosuppressive Agents
Vaccines

Immune Globulins

There is no evidence that immune globulin (immune globulin IM [IGIM], immune globulin IV [IGIV], immune globulin subcutaneous) or specific hyperimmune globulin (hepatitis B immune globulin [HBIG], rabies immune globulin [RIG], tetanus immune globulin [TIG], varicella zoster immune globulin [VZIG]) interferes with the immune response to inactivated vaccines.134 ACIP states that inactivated vaccines such as meningococcal groups A, C, Y, and W-135 vaccine (MenACWY vaccine) may be given concurrently with (using separate syringes and different injection sites) or at any interval before or after immune globulin preparations.134

Immunosuppressive Agents

Individuals receiving immunosuppressive therapy (e.g., alkylating agents, antimetabolites, certain biologic response modifiers, corticosteroids, cytotoxic drugs, radiation) may have reduced immune responses to vaccines, including MenACWY vaccine.1,61,72,105,108,134,135,152,228

Inactivated vaccines generally should be administered at least 2 weeks prior to initiation of immunosuppressive therapy and, because of possible suboptimal response, should not be administered during and for certain periods of time after immunosuppressive therapy is discontinued.105,134,135 Because the intervals between discontinuance of immunosuppressive therapy and restoration of immune competence vary depending on the type and intensity of immunosuppressive therapy, underlying disease, and other factors, optimal timing for vaccine administration following discontinuance of immunosuppressive therapy has not been identified for every situation.105

ACIP and the Infectious Diseases Society of America (IDSA) recommend that inactivated vaccines be administered at least 2 weeks before initiation of chemotherapy or radiation therapy, if possible, and avoided during such therapy.134,135 Individuals vaccinated during or within 14 days of starting chemotherapy or radiation therapy should be considered unimmunized134 and should be revaccinated at least 3 months after such therapy is discontinued if immunocompetence has been restored.134,135

Inactivated vaccines should be administered at least 2 weeks prior to treatment with anti-B-cell antibodies (e.g., rituximab).105,134 The optimal time to administer vaccines in patients who have received treatment with anti-B-cell antibodies is unclear.135 Some experts state that administration of inactivated vaccines should be deferred until at least 6 months after treatment with anti-B-cell antibodies has been discontinued.105,134,135

Inactivated vaccines should be administered at least 2 weeks prior to initiation of therapy with certain other immunosuppressive biologic response modifiers (e.g., colony-stimulating factors, interleukins, tumor necrosis factor-α inhibitors).105,134 Some experts states that, if an inactivated vaccine is indicated in a patient with a chronic inflammatory illness who is receiving maintenance therapy with an immunosuppressive agent, the vaccine should not be withheld because of concerns about exacerbation of the inflammatory illness.105,135

Corticosteroids given in greater than physiologic doses may reduce immune responses to vaccines.134 ACIP and AAP state that inactivated vaccines preferably should be administered at least 2 weeks prior to initiation of corticosteroid therapy that is considered immunosuppressive;105,134 however, if this is not feasible in patients receiving long-term corticosteroid therapy for inflammatory or autoimmune diseases, inactivated vaccines can be administered during such therapy.105 IDSA states that, although it may be reasonable to delay administration of inactivated vaccines in patients treated with high-dose corticosteroid therapy because of possible reduced immune responses, recommendations for use of MenACWY vaccine in individuals receiving corticosteroid therapy, including high-dose corticosteroid therapy, generally are the same as those for other individuals.135

Vaccines

Although specific studies may not be available evaluating concurrent administration with each antigen, concurrent administration of MenACWY vaccine with other age-appropriate vaccines, including live virus vaccines, toxoids, or inactivated or recombinant vaccines, during the same health-care visit usually is not expected to affect immunologic responses or adverse reactions to any of the preparations.90,105,108,134,228 (See Pneumococcal Vaccines under Drug Interactions.)

Immunization with MenACWY vaccine can be integrated with immunization against diphtheria, tetanus, pertussis, Haemophilus influenzae type b (Hib), hepatitis A, hepatitis B, human papillomavirus (HPV), influenza, measles, mumps, rubella, pneumococcal disease, poliomyelitis, and varicella.105,134,228 However, each parenteral vaccine should be administered using separate syringes and different injection sites.105,134

Inactivated Vaccines and Toxoids

Tetanus and Diphtheria Toxoids Adsorbed

In a double-blind, randomized study in adolescents 11 through 17 years of age, MenACWY-D (Menactra^®) was administered concomitantly with or 1 month after tetanus and diphtheria toxoids adsorbed (Td).108 Antibody responses to some meningococcal antigens (i.e., serogroups C, Y, W-135) were higher when MenACWY-D and Td were administered concomitantly than when MenACWY-D was administered 1 month after Td;108 antibody responses to the tetanus and diphtheria antigens were similar in both study groups.108 The overall rate of systemic adverse effects was higher when the vaccines were administered concomitantly.108

Diphtheria and Tetanus Toxoids and Pertussis Vaccines

ACIP states that MenACWY-D may be administered concurrently with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DTaP) using separate syringes and different injection sites.228 If the vaccines are not administered concurrently, ACIP states that MenACWY-D should be given before DTaP (during a different health-care visit) or at least 6 months after DTaP.228 This recommendation is based on some limited data suggesting interference with the immunologic response to meningococcal antigens (immunologic blunting) if MenACWY-D is administered following DTaP.228 However, if a child will be traveling to an area with high risk of meningococcal disease or is at risk during a community outbreak of meningococcal disease, ACIP states that MenACWY-D should be administered regardless of timing of DTaP administration.228 If MenACWY-D dose is inadvertently given within 6 months after DTaP, ACIP states that the MenACWY-D dose does not need to be repeated.228

Concurrent administration of MenACWY-D and tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap; Boostrix^®) was evaluated in a study in adolescents 11-18 years of age randomized to receive the vaccines concurrently (at different injection sites) or 1 month apart.193 The immune responses to the diphtheria, tetanus, and meningococcal antigens obtained following concurrent administration were noninferior to those reported when the vaccines were given 1 month apart.193 Although the immune response to the pertactin pertussis antigen (measured as geometric mean antibody concentration [GMC] of anti-pertactin) was lower when Tdap (Boostrix^®) was administered concurrently with MenACWY-D, it is not known whether efficacy of Tdap is affected by the reduced response to pertactin.193

MenACWY-D has been administered concurrently with Tdap (Adacel^®) and human papillomavirus 9-valent vaccine recombinant (9vHPV; Gardasil^® 9) in a randomized controlled study in adolescents 11 through 15 years of age.231,233 Concurrent administration of these 3 vaccines at different injection sites did not interfere with the antibody response to any of the vaccine antigens.233 (See Human Papillomavirus Vaccine under Drug Interactions.)

ACIP states that MenACWY-CRM may be administered concurrently with or at any interval before or after DTaP.228

In a randomized, controlled study in adolescents and young adults 11-25 years of age, concomitant administration of MenACWY-CRM and Tdap (Boostrix^®) did not affect the immune responses to the diphtheria, tetanus, and meningococcal antigens.240 However, immune responses to the pertussis antigens were lower when MenACWY-CRM and Tdap were administered concurrently compared with administration of Tdap alone.240

MenACWY-CRM has been administered concurrently with Tdap or with Tdap and human papillomavirus vaccine in a study in healthy adolescents 11 through 18 years of age.152 There was no interference with the immune response to the meningococcal antigens compared with administration of MenACWY-CRM alone.152 Although lower geometric mean antibody concentrations to the pertussis antigens were observed when MenACWY-CRM was administered concomitantly with Tdap and HPV vaccine compared with administration of Tdap alone, the clinical implications of the lower antibody response to the pertussis antigen in this study are not known.152 Systemic adverse reactions (e.g., headache, malaise, myalgia, arthralgia) were reported more frequently in those who received MenACWY-CRM, Tdap, and HPV vaccine concurrently compared with those who received MenACWY-CRM alone.152

In a randomized, controlled study in adolescents 10 through 17 years of age, concomitant administration of MenACWY-TT with Tdap (Boostrix^®) and human papillomavirus 4-valent vaccine recombinant (4vHPV; no longer available in the US) did not affect the immune responses to the diphtheria, tetanus, and meningococcal antigens.1 Although the immune response to the filamentous hemagglutinin, pertactin, and fimbriae pertussis antigens (measured as geometric mean antibody concentration [GMC] of anti-filamentous hemagglutinin, anti-pertactin, and anti-fimbriae) was lower when Tdap was administered concurrently with MenACWY-TT, the clinical implications of the lower antibody response to the pertussis antigen in this study are not known.1 There were no differences in adverse reactions reported within 7 days following concomitant administration of MenACWY-TT, Tdap, and 4vHPV in adolescents compared with administration of Tdap and 4vHPV without MenACWY-TT.1

Human Papillomavirus Vaccine

MenACWY-D has been administered concurrently with Tdap (Adacel^®) and 9vHPV (Gardasil^® 9) in adolescents 11 through 15 years of age.231 Concurrent administration of the 3 vaccines at different injection sites did not interfere with the antibody response to any of the vaccine antigens.231 Although the overall incidence of adverse reactions in those who received all 3 vaccines concurrently at different sites was similar to that reported when 9vHPV was given alone followed by MenACWY-D and Tdap 1 month later,231 concurrent administration of all 3 vaccines was associated with an increased incidence of swelling at the 9vHPV injection site compared with administration of the HPV vaccine alone.231

MenACWY-CRM has been administered concurrently with human papillomavirus quadrivalent (types 6, 11, 16, 18) vaccine, recombinant (4vHPV; no longer available in the US) and Tdap in adolescents 11 through 18 years of age.152 There was no interference with immune responses to the meningococcal antigens compared with administration of MenACWY-CRM alone.152 Systemic adverse reactions (e.g., headache, malaise, myalgia, arthralgia) were reported more frequently in the those who received 4vHPV, Tdap, and MenACWY-CRM concurrently compared with those who received MenACWY-CRM alone.152

MenACWY-TT has been administered concomitantly with 4vHPV and Tdap.1 Concurrent administration of the 3 vaccines did not affect the immune responses to the HPV or meningococcal antigens.1 There were no differences in adverse reactions reported within 7 days following concomitant administration of MenACWY-TT, Tdap, and 4vHPV in adolescents compared with administration of Tdap and 4vHPV without MenACWY-TT.1

Meningococcal Vaccines

ACIP and others state that MenACWY vaccine may be administered concurrently with meningococcal group B (MenB) vaccine (MenB-4C [Bexsero^®] or MenB-FHbp [Trumenba^®]) using separate syringes and different injection sites.134,200

MenACWY-D has been administered concurrently with MenB-FHbp (Trumenba^®) without a decrease in immune responses to the meningococcal antigens in either vaccine.236

Pneumococcal Vaccines

Concurrent administration of pneumococcal 7-valent conjugate vaccine (PCV7; no longer available in the US) with the second dose of MenACWY-D in infants at 12 months of age resulted in a decreased immune response to PCV7 (i.e., noninferiority criteria were not met for 3 of the 7 pneumococcal vaccine serotypes compared with administration of PCV7 without MenACWY-D).108,228

Concurrent administration of MenACWY-CRM and PCV7 in infants at 2, 4, 6, and 12 months of age resulted in possible interference with the antibody response to 2 of the pneumococcal vaccine serotypes at 1 month after the third dose, but no evidence of interference with immune response to any pneumococcal vaccine serotypes after the fourth dose.152

To avoid possible interference with the immune response to PCV13 in infants and children with anatomic or functional asplenia or HIV infection,105,228 ACIP states that MenACWY-D and PCV13 should not be administered concurrently and that the PCV13 immunization series should be completed first; MenACWY-D immunization should be initiated at least 4 weeks later.134,228

Typhoid Vaccine

MenACWY-D and parenteral inactivated typhoid Vi polysaccharide vaccine (Typhim Vi^®) have been administered concomitantly at different sites in adults 18 through 55 years of age108,228 without a reduced immune response to either vaccine228 and without a clinically important increase in adverse effects compared with administration alone.108,228 Because both vaccines are inactivated vaccines, parenteral inactivated typhoid vaccine (Typhim Vi^®) may be administered simultaneously with MenACWY vaccine (using separate syringes and different injection sites) or at any interval before or after the meningococcal vaccine.134

Results of a study in healthy adults who received a bivalent vaccine containing unconjugated meningococcal capsular polysaccharide antigens from serogroups A and C (not commercially available in the US) given concurrently with or 3-6 weeks before or after typhoid Vi capsular polysaccharide vaccine (Typhim Vi^®) indicate that concomitant administration of the vaccines does not affect the incidence of adverse effects or the antibody response to any of the antigens.15

Live Vaccines

Measles, Mumps, Rubella, and Varicella Vaccines

When MenACWY-D was administered with measles, mumps, and rubella virus vaccine live (MMR) and varicella virus vaccine live (VAR) (or the fixed-combination vaccine containing measles, mumps, rubella, and varicella antigens [MMRV]) and PCV7 (no longer available in the US) in infants 12 months of age, antibody responses to the measles, mumps, rubella, and varicella antigens approximately 30 days later were comparable to those reported in children who received MMRV (or MMR and VAR) and PCV7 without MenACWY-D.108,228

When MenACWY-CRM was administered concurrently with MMRV in infants 12 months of age, antibody responses to the measles, mumps, rubella, and varicella antigens measured 6 weeks after vaccination were comparable to those reported in infants who received MMRV alone.152 In addition, concurrent administration of MenACWY-CRM and MMRV in these infants did not increase the rate of solicited local or systemic adverse effects compared with administration of either vaccine alone.152

Typhoid Vaccine

ACIP states that oral live typhoid vaccine may be administered concurrently with or at any interval before or after MenACWY vaccine since meningococcal vaccines are inactivated vaccines.134

Yellow Fever Vaccine

Yellow fever vaccine has been administered concomitantly with a previously available unconjugated meningococcal vaccine (MPSV4; Menomune^®) without evidence of reduced antibody response to either vaccine and without any unusual adverse effects.92

Other Information ⬆ ⬇

[Section Outline]

Neisseria meningitidis and Infection
Response to Meningococcal Vaccines
Chemistry
Stability

Pharmacology

Meningococcal groups A, C, Y, and W-135 vaccines are inactivated (polysaccharide) vaccines that stimulate active immunity to infections caused by the Neisseria meningitidis serotypes represented in the vaccines (i.e., groups A, C, Y, and W-135).1,5,84,105,108,152,228 The antibody response to each of the antigens contained in quadrivalent meningococcal groups A, C, Y, and W-135 vaccines occurs independently of the response to the other antigens.1,5,59,60,77,84,85 These vaccines will not stimulate immunity to infection caused by meningococcal serogroups not represented in the vaccines (e.g., serogroup B) or to infection caused by other pathogens.1,5,79,84,85

Although a meningococcal groups A, C, Y, and W-135 polysaccharide vaccine containing unconjugated meningococcal antigens (MPSV4; Menomune^®) was previously available in the US,5 unconjugated meningococcal vaccines are no longer available the US. There currently are 3 different conjugated meningococcal groups A, C, Y, and W-135 (MenACWY) vaccines available in the US: meningococcal (groups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine (MenACWY-D; Menactra^®),108 meningococcal (groups A, C, Y and W-135) oligosaccharide diphtheria CRM₁₉₇ conjugate vaccine (MenACWY-CRM; Menveo^®),152 and meningococcal (groups A, C, Y and W-135) polysaccharide tetanus toxoid conjugate vaccine (MenACWY-TT; MenQuadfi^®).1 These quadrivalent conjugated vaccines contain capsular polysaccharide antigens extracted from 4 serotypes of N. meningitidis (A, C, Y, and W-135) with different carrier proteins.1,108,152 The meningococcal antigens contained in MenACWY-D are conjugated to diphtheria toxoid protein,108 the antigens contained in MenACWY-CRM are conjugated to diphtheria CRM₁₉₇ protein,152 and the meningococcal antigens contained in MenACWY-TT are conjugated to tetanus toxoid protein.1

Neisseria meningitidis and Infection

N. meningitidis is a gram-negative diplococcus that causes both endemic and epidemic disease.14,79,105,166 Based on chemical differences in the antigenic capsular polysaccharide of the organism, at least 13 different serogroups of N. meningitidis have been recognized (serogroups A, B, C, D, X, Y, Z, 29E, W-135, H, I, K, L).14,84,166 Serogroups involved in human disease include serogroups A, B, C, X, Y, Z, W-135, and L,14,84,85,166 with serogroups A, B, C, Y, and W-135 being responsible for the majority of cases worldwide.84,105,115

The proportion of cases caused by the N. meningitidis serotypes varies geographically and has changed over time.54,62,63,79,105,166 In the past 30 years, serogroups B and C have been responsible for the vast majority of cases of meningococcal disease in the Americas and Europe.84,85 Serogroup A and, to a lesser extent, serogroup C have been responsible for most meningococcal cases in Africa and in some areas of Asia.54,79,84,85,166

The proportion of cases of meningococcal disease caused by each serogroup varies by age.166 In the US, approximately 60% of cases of meningococcal disease reported in infants and children younger than 5 years of age and in young adults are caused by serogroup B.105,166

N. meningitidis frequently colonizes the upper respiratory tract, particularly the nasopharynx, without causing any symptoms.14,17,33,79,85,166 Asymptomatic nasopharyngeal carriage of the organism usually is transient and resolves within several weeks; however, a chronic carrier state can persist for up to 2 years.14,17,33 Up to 10% of adolescents and adults are asymptomatic carriers of N. meningitidis , although most of these individuals carry strains that are not pathogenic.166 The meningococcal carrier state is an immunizing process in most individuals and stimulates immunity against future infections caused by the serogroup involved.14,18 However, in some individuals, invasive N. meningitidis disease occurs resulting in potentially fatal meningococcemia and/or meningitis.17,33,66,79,166 In addition, asymptomatic N. meningitidis carriers may transmit the organism to others via respiratory secretions.79,105,166 Antecedent viral infection or concomitant respiratory infections, including those caused by influenza viruses or Mycoplasma , appear to enhance the spread of meningococcal infection, and such coincident infection, chronic underlying illness and active and passive smoking may contribute to the development of invasive disease in some patients.33,34,79,85,228 Overcrowding (e.g., close living conditions), bar or nightclub patronage, and alcohol use have been suggested as possible risk factors in the spread of meningococcal infection.79,85,166,228

N. meningitidis is a leading cause of bacterial meningitis and sepsis in children and young adults in the US.34,66,79,105,166 Despite improvements in supportive care and the use of anti-infective agents, the overall case fatality rate associated with invasive meningococcal disease in the US is 10-15% and the fatality rate can be higher in those with meningococcal sepsis (meningococcemia).105,166,228 Serious, long-term sequelae (e.g., neurologic disability, digit or limb loss, hearing loss) occur in up to 20% of surviving patients.78,79,105,166,228

Susceptibility to invasive meningococcal disease appears to be related to low or absent levels of bactericidal antibodies against the infecting pathogenic serogroup.14,17,18,33,34,39,69,79 However, other antibodies (including those involved in opsonization or directed against noncapsular antigens) also may contribute to protection against meningococcal disease.69 Bactericidal antibodies formed in response to N. meningitidis infection or administration of meningococcal polysaccharide vaccine consist of IgG, IgM, and IgA antibodies.13,17,18,33,69,79 The relative importance of each type of antibody in providing initial and long-term bactericidal protection against N. meningitidis has not been determined.13,17,42,46,69,79 While the clinical importance is unclear, there is some evidence that IgA produced locally actually may impair the bactericidal activity of IgG and IgM.13,17,42,46,69,79,90

Response to Meningococcal Vaccines

Unconjugated Meningococcal Vaccines

The group-specific capsular polysaccharides contained in the previously available unconjugated meningococcal groups A, C, Y, and W-135 polysaccharide vaccine (MPSV4) were T-cell-independent antigens that stimulated a primary antibody response following subcutaneous administration and could not induce long-lasting immunity or an anamnestic response after subsequent exposure to the same antigens.51,59,78,84,108,134,228 Anticapsular antibodies formed in response to unconjugated meningococcal polysaccharide vaccines generally appear in serum within 7 days and peak within 14 days.13,26,42,43,69

The immunologic response to a specific unconjugated meningococcal capsular polysaccharide antigen is the same regardless of whether the antigen is administered as a component of a monovalent, bivalent, or quadrivalent meningococcal vaccine.8,19,41,59 The antibody response to each antigen is independent of and does not appear to affect the response to the other antigens.8,20,59,77 The magnitude of response to each specific antigen generally is inversely related to group-specific antibody levels present prior to vaccination.8,20,59 In addition, the extent and duration of the immunologic response to unconjugated meningococcal polysaccharide vaccines vary depending on the age of the recipient; the vaccines are less immunogenic in children younger than 2 years of age than in older children and adults.24,28,31,42,46,62,84,85

Conjugated Meningococcal Vaccines

The capsular polysaccharide antigens contained in MenACWY-D are conjugated to diphtheria toxoid protein,108,228 the capsular polysaccharide antigens contained in MenACWY-CRM are conjugated to CRM₁₉₇ protein,152,228 and the capsular polysaccharide antigens contained in MenACWY-TT are conjugated to tetanus toxoid protein.1,228 Conjugation of meningococcal capsular polysaccharide antigens to protein carriers with T-cell epitopes changes the immune response to the vaccine polysaccharides from T-cell-independent to T-cell-dependent, resulting in an improved primary response to the antigens and a stronger anamnestic response (i.e., immunologic memory) at re-exposure to the antigens.108,134,228

Infants 2 through 23 Months of Age

The effectiveness of MenACWY-CRM for primary immunization against meningococcal serogroups A, C, Y, and W-135 infection in infants was evaluated in a randomized, controlled, multicenter study.152 In this study, infants received MenACWY-CRM at 2, 4, 6, and 12 months of age and immunogenicity was assessed using predefined criteria based on serum bactericidal antibodies measured using human complement (hSBA).152 At 1 month following the third dose (7 months of age), the proportion of infants with hSBA at least 1:8 was 94-98% for serogroups C, W-135, and Y and 76% for serogroup A.152 At 1 month after the fourth dose, the predefined criteria for immunogenicity were met for all 4 serogroups.152

The effectiveness of a 2-dose regimen of MenACWY-CRM for primary immunization against meningococcal serogroups A, C, Y, and W-135 infection in infants 7 months of age and older was evaluated in a randomized, controlled, multicenter study.152 In this study, infants received MenACWY-CRM at 7-9 and 12 months of age.152 In the per protocol population who received both vaccine doses, the proportion of infants with hSBA at least 1:8 for serogroups A, C, W-135, and Y was 88, 100, 98, and 96%, respectively.152

Adults, Adolescents, and Children, 2 Years of Age or Older

In a limited study in healthy children 2 through 10 years of age, the immunologic response to a single dose of MenACWY-D was similar to that obtained with a single dose of unconjugated MPSV4 (no longer available in the US).108,114 In a study in adolescents and young adults 11 through 18 years of age who were randomized to receive a single dose of MenACWY-D or MPSV4 (no longer available in the US), the immune response to both vaccines was similar for all 4 N. meningitidis serotypes (i.e., A, C, Y, W-135).108 At 28 days after vaccination, the seroconversion rate (defined as 4-fold or greater increase in serum bactericidal antibody) to the 4 serotypes was 82-97% in those who received the conjugated vaccine and 80-95% in those who received the unconjugated vaccine.108 In a similar study in adults 18 through 55 years of age, the seroconversion rate at 28 days after a single dose was 74-89% in those who received the conjugated vaccine and 79-94% in those who received the unconjugated vaccine.108

The immune response to a single dose of MenACWY-CRM in individuals 2 through 55 years of age is similar to that reported with a single dose of MenACWY-D.152 Results of a randomized, multicenter, active-controlled study in adolescents 11 through 18 years of age and adults 19 through 55 years of age indicate that seroresponses to all 4 N. meningitidis serotypes at 28 days after a single dose of MenACWY-CRM are noninferior to seroresponses obtained with a single dose of MenACWY-D.152 In a similar study that compared seroresponses at 28 days after a single dose of MenACWY-CRM or MenACWY-D in children 2 through 10 years of age, the response to MenACWY-CRM was noninferior to that obtained with MenACWY-D for serogroups C, Y, and W-135; however, the noninferiority criterion was not met for serogroup A.152 In a separate group of children 2 through 5 years of age randomized to receive 2 doses of MenACWY-CRM administered 2 months apart, seroresponse rates 1 month after the second dose were 91% for serogroup A, 98% for serogroup C, 95% for serogroup Y, and 89% for serogroup W-135.152

In clinical studies in children and adolescents 2 through 17 years of age, seroresponse rates at 1 month in those who received a dose of MenACWY-TT were noninferior to seroresponses in those who receive a single dose of unconjugated vaccine (Menveo^®; no longer available in the US).1 In a study in adults 18 through 55 years of age, seroresponse rates for all 4 N. meningitidis serogroups at 1 month in those who received a dose of MenACWY-TT were noninferior to seroresponse rates in those who received a single dose of MenACWY-D.1

Booster Doses

In an open-label trial conducted in the US, 834 individuals who had previously received a dose of MenACWY-D received a booster dose of the vaccine 4-6 years after the prior dose (median age at the time of the booster dose was 17.1 years).108 Prior to the booster dose, approximately 65, 44, 39, and 69% of 781 trial participants had hSBA titers of at least 1:8 for meningococcal serogroups A, C, Y, and W-135, respectively.108 At day 28 after the booster dose, more than 99% of trial participants had hSBA titers of at least 1:8 for each of the meningococcal serogroups.108 In a subset of 112 trial participants for whom hSBA responses were assessed at day 6 after the booster dose, approximately 87, 91, 95, and 92% achieved at least a fourfold increase in hSBA titer for meningococcal serogroups A, C, Y, and W-135, respectively.108 Data for all 781 trial participants indicated that by day 28 after the booster dose, 95, 95, 97, and 96% had achieved at least a fourfold increase in hSBA titer for meningococcal serogroups A, C, Y, and W-135, respectively.108

In an open-label multicenter trial conducted in the US, 601 individuals who had previously received a dose of MenACWY-CRM or MenACWY-D received a booster dose of MenACWY-CRM given 4-6 years after the prior dose (median age at the time of the booster dose was 16 years).152 In 290 trial participants who previously received MenACWY-CRM, 12, 62, 54, and 76% had hSBA titers of at least 1:8 for meningococcal serogroups A, C, Y, and W-135, respectively, prior to the booster dose;152 at day 29 after the booster dose, the seroresponse rates in these individuals were 97, 95, 97, and 96% for meningococcal serogroups A, C, Y, and W-135, respectively.152 In individuals who had previously received a dose of MenACWY-D, seroresponse rates after the booster dose of MenACWY-CRM were similar to those in the group who had previously received MenACWY-CRM.152

In a double-blind, randomized, parallel-group trial, 402 adolescents and adults 15 years of age or older who had previously received a dose of MenACWY-D or unconjugated MPSV4 (no longer available in the US) received a booster dose of MenACWY-TT given 4-10 years after the prior dose (median age at the time of the booster dose was 18 years).1 Seroresponse rates at 1 month after the booster dose were 92, 97, 97, and 98% for meningococcal serogroups A, C, Y, and W-135, respectively.1

Asplenic Individuals

Asplenic individuals may have a lower response rate to conjugated meningococcal vaccines than healthy individuals and there is some evidence that a 2-dose primary series may be more effective in these individuals.228 In one study in asplenic individuals who received a dose of a meningococcal group C conjugate vaccine (not commercially available in the US), 20% of these individuals did not achieve serum bactericidal titers measured using rabbit complement (rSBA) of at least 1:8.228 When these nonresponders received a second dose of the meningococcal group C conjugate vaccine 2 months later, only 7% were still considered nonresponders.228

HIV-infected Individuals

Studies in adolescents and adults 11 through 24 years of age with human immunodeficiency virus (HIV) infection indicate that a single dose of MenACWY-D is safe and immunogenic in such individuals, but the response rate is lower than the response rate reported in healthy individuals in this age group.158,159 A second dose of MenACWY-D administered 6 months after the first dose substantially improved response rates in HIV-infected individuals 11 through 24 years of age with CD4⁺ T-cell percentages of 15% or greater.159 Individuals with CD4⁺ T-cell percentages less than 15% at study entry had lower response rates despite 2 doses of MenACWY-D.159 In another study in HIV-infected children 2 through 10 years of age with CD4⁺ T-cell percentages greater than 25%, 2 doses of MenACWY-D administered 6 months apart were safe and immunogenic.160 Most HIV-infected children who did not respond to the first dose did respond to the second dose.160

Chemistry and Stability

Chemistry

Meningococcal groups A, C, Y, and W-135 vaccine is commercially available in the US as 3 different conjugated vaccines: meningococcal (groups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine (MenACWY-D; Menactra^®),108 meningococcal (groups A, C, Y and W-135) oligosaccharide diphtheria CRM₁₉₇ conjugate vaccine (MenACWY-CRM; Menveo^®),152 and meningococcal (groups A, C, Y and W-135) polysaccharide tetanus toxoid conjugate vaccine (MenACWY-TT; MenQuadfi^®).1 These vaccines contain A, C, Y, and W-135 capsular polysaccharide antigens extracted from Neisseria meningitidis , but these antigens are covalently linked to different T-cell dependent carrier proteins depending on the specific vaccine.1,105,106,108,152,228

Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (MenACWY-D; Menactra®)

MenACWY-D is a sterile solution containing purified capsular polysaccharide antigens A, C, Y, and W-135 extracted from N. meningitidis and conjugated to diphtheria toxoid protein.108 Each serotype of N. meningitidis is cultured and grown on suitable media and the individual polysaccharides are extracted and purified using centrifugation, alcohol and detergent precipitation, solvent extraction, and diafiltration.108 The polysaccharides are depolymerized, derivatized, and purified by diafiltration to prepare them for conjugation and the derivatized polysaccharides are then each individually covalently linked to diphtheria toxoid protein and purified by serial diafiltration to form the serogroup-specific glycoconjugates.108 Potency of MenACWY-D is determined by quantification of each of the polysaccharide antigens conjugated to diphtheria toxoid protein and the unconjugated polysaccharide antigens present.108

MenACWY-D commercially available in the US occurs as a clear to slightly turbid liquid.108 Each 0.5-mL dose of MenACWY-D contains 4 mcg of each polysaccharide for N. meningitidis serotypes A, C, Y, and W-135, approximately 48 mcg of diphtheria toxoid carrier protein, and not more than 2.66 mcg of residual formaldehyde.108 MenACWY-D does not contain thimerosal or any other preservative.108

Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (MenACWY-CRM; Menveo®)

MenACWY-CRM contains purified capsular oligosaccharide antigens A, C, Y, and W-135 extracted from N. meningitidis and conjugated to Corynebacterium diphtheriae CRM₁₉₇ protein.152 Each serotype of N. meningitidis is cultured and grown on suitable media and treated with formaldehyde.152 The meningococcal polysaccharide antigens A, Y, and W-135 are purified by several extraction and precipitation steps;152 the meningococcal polysaccharide antigen C is purified by a combination of chromatography and precipitation.152 The oligosaccharides are prepared for conjugation from purified polysaccharides by hydrolysis, sizing, and reductive amination.152 After activation, each oligosaccharide is then individually covalently linked to the diphtheria CRM₁₉₇ protein and purified to form the serogroup-specific glycoconjugates.152

MenACWY-CRM commercially available in the US is supplied as 2 components that must be combined prior to administration: a lyophilized component containing meningococcal oligosaccharide antigen A (MenA) and a liquid component containing meningococcal oligosaccharide antigens C, Y, and W-135 (MenCYW-135).152 When the lyophilized component is reconstituted with the liquid component as directed, each 0.5-mL dose of MenACWY-CRM contains 10 mcg of N. meningitidis oligosaccharide serotype A, 5 mcg each of N. meningitidis oligosaccharide serotypes C, Y, and W-135, and 32.7-64.1 mcg of diphtheria CRM₁₉₇ protein.152 Each 0.5-mL dose is estimated to contain not more than 0.3 mcg of residual formaldehyde from the manufacturing process.152 The reconstituted vaccine occurs as a clear, colorless solution.152 MenACWY-CRM does not contain thimerosal or any other preservative.152

Meningococcal (Groups A, C, Y and W-135) Polysaccharide Tetanus Toxoid Conjugate Vaccine (MenACWY-TT; MenQuadfi®)

MenACWY-TT is a sterile solution containing purified capsular polysaccharide antigens A, C, Y, and W-135 extracted from N. meningitidis and conjugated to tetanus toxoid protein.1 Each serotype of N. meningitidis is cultured and grown on suitable media and the individual polysaccharides are extracted and purified using centrifugation, detergent and alcohol precipitation, solvent extraction, and diafiltration.1 The polysaccharides are depolymerized or derivatized and then purified by diafiltration to prepare them for conjugation, and the derivatized polysaccharides are then each individually covalently linked to tetanus toxoid protein and purified by chromatography and serial diafiltration to form the serogroup-specific glycoconjugates.1 Potency of MenACWY-TT is determined by quantification of each of the polysaccharide antigens conjugated to tetanus toxoid protein and the unconjugated polysaccharide present.1

MenACWY-TT commercially available in the US occurs as a clear, colorless solution.1 Each 0.5-mL dose of MenACWY-TT contains 10 mcg of each polysaccharide for N. meningitidis serotypes A, C, Y, and W-135 conjugated to approximately 55 mcg of tetanus toxoid carrier protein and contains residual amounts of formaldehyde.1 MenACWY-TT does not contain thimerosal or any other preservative.1

Stability

Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (MenACWY-D; Menactra®)

MenACWY-D should be refrigerated at 2-8°C and should not be frozen.108 If freezing occurs, the vaccine should be discarded.108 The vaccine should be protected from light.134

Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (MenACWY-CRM; Menveo®)

Prior to reconstitution, both the lyophilized and liquid components of MenACWY-CRM should be refrigerated at 2-8°C and should not be frozen.152 If the vaccine components or reconstituted vaccine is frozen, they should be discarded.152 The vaccine components and reconstituted vaccine should be protected from light.152 MenACWY-CRM components must be maintained at 2-8°C during transport.152

MenACWY-CRM should be used immediately after reconstitution, but may be stored at 2-25°C for up to 8 hours.152

Meningococcal (Groups A, C, Y and W-135) Polysaccharide Tetanus Toxoid Conjugate Vaccine (MenACWY-TT; MenQuadfi®)

MenACWY-TT should be refrigerated at 2-8°C and should not be frozen.1 If freezing occurs, the vaccine should be discarded.1

Preparations ⬆ ⬇

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (MenACWY-D)

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Injection, for IM use	4 mcg each of meningococcal A, C, Y, W-135 capsular polysaccharides conjugated to approximately 48 mcg of diphtheria toxoid protein carrier per 0.5 mL	Menactra^®	Sanofi Pasteur

Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (MenACWY-CRM)

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	For injection, for IM use	10 mcg of meningococcal A capsular polysaccharide and 5 mcg each of meningococcal C, Y, W-135 capsular oligosaccharides conjugated to 32.7-64.1 mcg of diphtheria CRM₁₉₇ protein carrier per 0.5 mL	Menveo^®	GlaxoSmithKline

Meningococcal (Groups A, C, Y and W-135) Polysaccharide Tetanus Toxoid Conjugate Vaccine (MenACWY-TT)

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Injection, for IM use	10 mcg each of meningococcal A, C, Y, W-135 capsular polysaccharides conjugated to approximately 55 mcg of tetanus toxoid protein carrier per 0.5 mL	MenQuadfi^®	Sanofi Pasteur

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References ⬆

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section name header

Introduction ⬇

AHFS Class:

Generic Name(s):

Uses ⬆ ⬇

Dosage and Administration ⬆ ⬇

Cautions ⬆ ⬇

Drug Interactions ⬆ ⬇

Other Information ⬆ ⬇

Preparations ⬆ ⬇

Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (MenACWY-D)

Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (MenACWY-CRM)

Meningococcal (Groups A, C, Y and W-135) Polysaccharide Tetanus Toxoid Conjugate Vaccine (MenACWY-TT)

Copyright ⬆ ⬇

References ⬆