Haemophilus B Vaccine

[Section Outline]

Risks of Exposure and Infection
Choice of Hib Vaccines
Primary and Booster Immunization
Postexposure Prophylaxis

Haemophilus b (Hib) conjugate vaccine (meningococcal protein conjugate) (PRP-OMP; PedvaxHIB^®) and Hib conjugate vaccine (tetanus toxoid conjugate) (PRP-T; ActHIB^®, Hiberix^®) are used to stimulate active immunity to invasive disease caused by Haemophilus influenzae type b (Hib).105,144,159,166,174,223 Hib vaccines will not provide protection against other types of H. influenzae (e.g., nonencapsulated [nontypeable] strains) or against other microorganisms that cause meningitis, septicemia, or other invasive infections.144,159,174

The US Public Health Service Advisory Committee on Immunization Practices (ACIP), American Academy of Pediatrics (AAP), and other experts recommend routine primary and booster immunization against Hib infection in all infants and children 2 through 59 months of age.105,159,199 ACIP, AAP, and other experts also recommend use of Hib vaccine in certain individuals 5 years of age and older† at increased risk for invasive Hib disease because of certain medical conditions.105,159,199,200 (See Uses: Primary and Booster Immunization.)

Risks of Exposure and Infection

Hib is a gram-negative bacterium that causes meningitis and other serious infections (e.g., pneumonia, epiglottitis, sepsis, cellulitis, septic arthritis, osteomyelitis, endocarditis, purulent pericarditis), principally in infants and children younger than 5 years of age.105,159,166

Prior to the availability of Hib vaccine, Hib was the most common cause of bacterial meningitis and other invasive bacterial disease in young children worldwide105,166 and there were approximately 20,000 cases of invasive Hib disease (including approximately 12,000 cases of Hib meningitis) reported annually in the US, principally in infants and children younger than 5 years of age.144,166 The case fatality rate was 3-6% despite appropriate anti-infective treatment and 15-30% of meningitis survivors had hearing loss or neurologic sequelae.166 After Hib vaccine became available, the incidence of invasive Hib disease in the US decreased by 99%105,166 to fewer than 1 case per 100,000 children younger than 5 years of age.105 Most cases now occur in infants and children who are unvaccinated or incompletely vaccinated, including infants younger than 6 months of age who are too young to have received a complete vaccination series.105,166 During 2012, there were only 30 cases of invasive Hib disease reported in US children younger 5 years of age.105 Nontypeable H. influenzae is now the leading cause of invasive H. influenzae disease in all age groups.105

Unvaccinated children younger than 5 years of age are at increased risk of invasive Hib disease, especially if they are household contacts of a child with invasive Hib disease.105 Some factors associated with an increased risk of invasive Hib infection include functional or anatomic asplenia,105,134,166 sickle cell disease,105,166 antibody deficiency syndromes,166 human immunodeficiency virus (HIV) infection,105,134,156,166 other immunodeficiency syndromes,38,105,134,166 and Hodgkin's disease79 or other malignancies (especially during chemotherapy or radiation therapy).105,134,166 Historically, invasive Hib disease was more common in American Indians (e.g., Apache and Navajo tribes),45,105,166 Alaskan natives,40,45,85,105 Hispanics,166 blacks,29,105,166 boys,105 daycare attendees,105,166 children living in crowded conditions,105,166 and children who were not breastfed.105

Outbreaks or direct secondary transmission of invasive Hib disease can occur under certain circumstances, particularly when unvaccinated or incompletely vaccinated infants and children younger than 4 years of age are exposed through close contact with an index patient in household, child-care, or institutional settings.105,166 Attack rates vary substantially with age, and have been reported to be about 4% among susceptible contacts 2 years of age and younger and 0% among contacts 6 years of age or older.166 A secondary attack rate of 0.3% has been reported among household contacts in the month following onset of the index case (about 600 times higher than the risk for the general population).166 Most secondary cases in households occur during the first week after hospitalization of the index case.105,166 Data are conflicting regarding the risk of secondary transmission among child-care contacts, and secondary attack rates of 0-2.7% have been reported.166 Most studies suggest that child-care contacts are at relatively low risk for secondary transmission of Hib disease, particularly if contacts have received age-appropriate vaccination with Hib vaccine.166 Rifampin prophylaxis may be indicated to decrease the risk of secondary systemic Hib disease in exposed contacts.105 (See Uses: Postexposure Prophylaxis.)

Choice of Hib Vaccines

Monovalent Hib Conjugate Vaccines

There are 2 different types of monovalent Hib conjugate vaccine commercially available in the US for active immunization against invasive disease caused by Hib: PRP-OMP (PedvaxHIB^®)144 and PRP-T (ActHIB^®, Hiberix^®).174,223

ACIP and AAP state that PRP-OMP is preferred for primary immunization against invasive Hib disease in American Indian and Alaskan native children 6 weeks of age and older.105,159 The peak incidence of Hib meningitis in these populations occurs at a younger age (4-6 months) than in other US infants and there is evidence that vaccines containing PRP-OMP can induce protective antibody levels after the first dose and provide earlier protection than vaccines containing PRP-T.105,159 After primary immunization with PRP-OMP, American Indian and Alaskan native children can receive any commercially available age-appropriate Hib vaccine (PRP-OMP or PRP-T) for the booster dose given at 12 through 15 months of age.159

In all other infants and children, ACIP and AAP do not state a preference for the type of Hib vaccine and state that all age-appropriate monovalent Hib vaccines (PRP-OMP or PRP-T) are considered interchangeable for primary and booster doses.105,159 However, the dosing schedule (i.e., number and timing of doses) differs depending on which vaccine type is used.105,159 (See Dosage and Administration: Dosage.)

Combination Vaccines Containing Hib Vaccine and Other Antigens

PRP-T Hib vaccine also is commercially available in a combination vaccine that contains diphtheria, tetanus, pertussis, poliovirus, and Hib antigens (DTaP-IPV/Hib; Pentacel^®).224 DTaP-IPV/Hib can be used when doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DTaP), poliovirus vaccine inactivated (IPV), and Hib vaccine are indicated in infants and children 6 weeks through 4 years of age and there are no contraindications to any of the individual components.207,224 For prevention of Hib, ACIP states that DTaP-IPV/Hib may be used for the primary immunization doses and the booster dose at 12 through 15 months of age.207

Data are not available regarding the interchangeability of DTaP-IPV/Hib and monovalent Hib vaccines.159

Primary and Booster Immunization

ACIP, AAP, and other experts recommend that all infants receive primary and booster immunization against Hib disease initiated at 2 months of age (minimum age 6 weeks) with an appropriate Hib vaccine.105,159,199 These experts also recommend catch-up vaccination for all children younger than 5 years of age who are unvaccinated or incompletely vaccinated against Hib disease.105,159,199

Although Hib vaccine is not usually recommended in adults, adolescents, or children 5 years of age or older, it may be considered in certain individuals 5 years of age and older† at increased risk for invasive Hib disease because of certain medical conditions.105,159,199,200 (See Adults and Children 5 Years of Age or Older under Uses: Primary and Booster Immunization.)

Primary immunization against Hib infection can be integrated with age-appropriate primary immunization against diphtheria, tetanus, pertussis, hepatitis B, influenza, pneumococcal disease, poliomyelitis, rotavirus, measles, mumps, rubella, and varicella.105,134,159,163,179,199 (See Drug Interactions: Vaccines.)

Children 2 through 15 Months of Age

ACIP, AAP, and other experts recommend that all children receive primary and booster immunization against Hib infection beginning at 2 months of age (minimum age 6 weeks).105,159,199 Catch-up vaccination with an age-appropriate Hib vaccine is recommended if primary immunization was not initiated at 2 months of age.105,159,199

If monovalent Hib vaccine containing PRP-OMP (PedvaxHIB^®) is used for active immunization against Hib disease in infants, 2 primary doses are given at 2 and 4 months of age and 1 booster dose is given at 12 through 15 months of age.105,144,159,199 If monovalent Hib vaccine containing PRP-T (ActHIB^®, Hiberix^®) is used, 3 primary doses are given at 2, 4, and 6 months of age and 1 booster dose is given at 12 through 18 months of age.105,159,174,199,223 Alternatively, if the combination vaccine DTaP-IPV/Hib (Pentacel^®) is used for primary and booster immunization in infants, 3 primary doses are given at 2, 4, and 6 months of age and 1 booster dose is given at 12 through 18 months of age.105,159,199,224

ACIP, AAP, and other experts recommend that the booster dose be given at 12 through 15 months of age and at least 2 months (8 weeks) after the last primary dose and state that any age-appropriate Hib vaccine (monovalent or combination vaccine) may be used for the booster dose.105,159,199

PRP-OMP is preferred for primary immunization against invasive Hib disease in American Indian and Alaskan native infants.105,159 (See Uses: Choice of Hib Vaccines.)

Medically stable preterm infants generally should receive primary immunization against Hib infection at the usual chronologic age.105,134,144,159 (See Cautions: Pediatric Precautions.)

Children 15 through 59 Months of Age

ACIP, AAP, and other experts recommend that all children who are 15 through 59 months of age and have not yet received primary immunization against Hib infection receive a single dose of an age-appropriate Hib vaccine.105,159,199 Additional or booster doses of Hib vaccine (monovalent or combination vaccine) are not usually recommended for children who received a first dose at 15 months of age or older.159,199

Adults and Children 5 Years of Age or Older

PRP-OMP (PedvaxHIB^®) and PRP-T (ActHIB^®) are labeled by FDA for use in children through 5 years of age (prior to sixth birthday);144,174 PRP-T (Hiberix^®) and DTaP-IPV/Hib (Pentacel^®) are labeled by FDA for use in children through 4 years of age (prior to fifth birthday).223,224 Efficacy and safety of Hib vaccines have not been established in older children or adults.144,174,223,224,225

Although ACIP, AAP, and other experts do not recommend routine use of Hib vaccine in individuals 5 years of age or older, these experts state that certain adults† and children 5 years of age or older† at increased risk for invasive Hib disease should receive the vaccine.105,135,156,159,166,199,200 (See Individuals at Increased Risk Because of Certain Medical Conditions under Uses: Primary and Booster Immunization.)

Individuals at Increased Risk Because of Certain Medical Conditions

Individuals with certain immunocompromising conditions are considered at increased risk of invasive Hib disease.105,159 This includes individuals with functional or anatomic asplenia, sickle cell disease, immunoglobulin deficiency (including IgG₂ deficiency), early component complement deficiency, or HIV infection and those who have undergone hematopoietic stem cell transplantation (HSCT) or are receiving chemotherapy or radiation therapy for malignant neoplasms.105,134,159

Children 12 through 59 months of age who are at increased risk for Hib disease and are unvaccinated or incompletely vaccinated should receive Hib vaccine according to age-specific recommendations.105,159,199 Children at high risk who have received no doses or only 1 dose of Hib vaccine before 12 months of age should receive 2 doses of any age-appropriate Hib vaccine given 2 months (8 weeks) apart;105,159,199 those who received 2 or more doses of Hib vaccine before 12 months of age should receive 1 additional dose given at least 8 weeks after the last dose.105,159,199 Although it is unclear whether children at increased risk of invasive Hib disease (e.g., those with HIV infection, IgG₂ deficiency, early component complement deficiency) would benefit from additional doses of Hib vaccine after completion of the usual age-appropriate vaccination regimen,105 ACIP and AAP state that no additional doses are necessary in those who received the complete primary immunization series of Hib vaccine followed by a booster dose given at 12 months of age or older.105,159

Previously unvaccinated children 5 years of age or older† with underlying disease predisposing to Hib disease should receive a single dose of Hib vaccine.105,135,159,199

Hib vaccine also is recommended in certain adults† with medical conditions that increase the risk of invasive Hib disease.159,200

The fact that the immune response to Hib vaccine may be reduced in immunocompromised individuals should be considered.105,134,135 (See Individuals with Altered Immunocompetence under Cautions: Precautions and Contraindications.)

Anatomic or Functional Asplenia and Sickle Cell Disease

Children 12 through 59 months of age with decreased or absent splenic function who received a primary immunization series in early infancy followed by a booster dose at 12 months of age or older do not need further doses of Hib vaccine.105,159,199 Those who received a complete age-appropriate primary and booster immunization series of Hib vaccine but are scheduled for splenectomy (e.g., for Hodgkin's disease, spherocytosis, immune thrombocytopenia, hypersplenism) may benefit from an additional dose of Hib vaccine given at least 14 days prior to the procedure.105,159,199

Adults†, adolescents†, and children 5 years of age or older† who have anatomic or functional asplenia or sickle cell disease and are unvaccinated (i.e., did not receive a primary series and a booster dose of Hib vaccine in early infancy or at least 1 dose of Hib vaccine after 14 months of age) should receive a single dose of Hib vaccine.105,134,135,159,199,200

Unvaccinated adults†, adolescents†, and children 15 months of age or older (including children 5 years of age or older†) undergoing splenectomy should receive a single dose of Hib vaccine administered at least 14 days before surgery.105,134,159,199,200 Some experts suggest administering a dose of Hib vaccine at least 14 days before splenectomy regardless of prior vaccination history.159 If Hib vaccine was not administered before splenectomy, the dose should be administered as soon as possible at least 2 weeks after surgery when the patient's condition is stable.105,134

HIV-infected Individuals

ACIP, AAP, Centers for Disease Control and Prevention (CDC), National Institutes of Health (NIH), HIV Medicine Association of the Infectious Diseases Society of America (IDSA), and AAP state that recommendations regarding use of Hib vaccine in HIV-infected infants and children up to 5 years of age are the same as those for individuals who are not infected with HIV.105,134,135,156 It is unclear whether HIV-infected children would benefit from additional doses of Hib vaccine after completion of the usually recommended primary and booster immunization series.105,159

HIV-infected children and adolescents 5 through 18 years of age† who are unvaccinated or incompletely vaccinated against Hib should receive a single dose of Hib vaccine.105,134,135,156,159,166,199

Because the incidence of Hib infection in HIV-infected adults is low, Hib vaccine is not usually recommended in HIV-infected adults, unless they also have anatomic or functional asplenia.134,155,159,200

Immunization may be less effective in individuals with HIV infection than in immunocompetent individuals since the antibody response to vaccines may be reduced and may be inversely correlated with severity of the disease.105,134

Hematopoietic Stem Cell Transplant Recipients

Adults†, adolescents†, and children (including children 5 years of age or older†) who have undergone HSCT should be considered unvaccinated, regardless of any prior doses of Hib vaccine.159 ACIP, AAP, and other experts state that, starting 6-12 months after successful transplant, all HSCT recipients should receive 3 doses of Hib vaccine given at least 1 month (4 weeks) apart.134,135,159,199,200

Individuals undergoing Chemotherapy or Radiation Therapy

Hib vaccination generally should be avoided during chemotherapy or radiation therapy because of possible suboptimal response.105,134,159 If Hib vaccine is indicated in an individual who will be receiving immunosuppressive therapy, the vaccine should be administered at least 2 weeks prior to initiation of such therapy if possible.105,135 Children younger than 5 years of age who received Hib vaccine within 14 days prior to initiation of immunosuppressive therapy or while receiving immunosuppressive therapy should be considered unimmunized, and vaccine doses should be repeated beginning at least 3 months after such therapy is discontinued.105,134,159 In patients receiving treatment with anti-B-cell antibodies (e.g., rituximab), Hib vaccination should be deferred until at least 6 months after such therapy is discontinued.105,134 (See Drug Interactions: Immunosuppressive Agents.)

Individuals Vaccinated Outside the US

The immune status of individuals vaccinated outside the US (e.g., children adopted from other countries, immigrants) may be difficult to determine based on country of origin and medical records.134 Such individuals whose immune status is uncertain should be vaccinated according to the US recommended immunization schedules.134 The fact that immunization schedules of other countries may differ from US schedules (e.g., different recommended vaccines, recommended ages of administration, and/or number and timing of vaccine doses) should be considered.134 Vaccines administered outside the US can generally be accepted as valid if there is documentation and the administration schedule was similar to that recommended in the US immunization schedules.134 Only written vaccination records should be considered as evidence of previous vaccination since such records are more likely to accurately predict protection if the specific vaccines administered, intervals between doses, and individual's age at the time of vaccination are similar to US recommendations; however, the extent to which an internationally adopted child's immunization record reflects their protection against disease is unclear and it is possible there may be transcription errors in such records (e.g., single-antigen vaccine may have been administered although a multiple-antigen vaccine was recorded).134 Although vaccines with inadequate potency have been produced in other countries, the majority of vaccines used worldwide are immunogenic and produced with adequate quality control standards.134

When the immune status of an internationally adopted child is uncertain, ACIP recommends that health-care providers either repeat vaccinations (since this usually is safe and avoids the need to obtain and interpret serologic tests) and/or use selective serologic testing to determine the need for immunizations (helps avoid unnecessary injections).134 However, interpretation of serologic tests used to verify whether a child vaccinated more than 2 months previously is protected against Hib can be difficult.134 Therefore, because the required number of doses needed for protection against Hib decreases with age and because adverse effects reported with Hib vaccines are rare, ACIP recommends age-appropriate revaccination.134

Children Younger than 24 Months of Age with Invasive Hib Infection

Children younger than 24 months of age who develop systemic Hib infection may be at risk of developing a second episode of the disease since most children in this age group fail to develop adequate immunity following natural infection.105,159,166 Such children should be considered unvaccinated, regardless of prior doses of Hib vaccine, and should receive age-appropriate primary immunization as if they had received no previous doses of Hib vaccine;105,159,166 the immunization series should be initiated 1 month (4 weeks) after disease onset or as soon as possible thereafter.105,159

Postexposure Prophylaxis

Data are insufficient to determine whether Hib vaccine administered immediately after exposure to natural Hib would prevent illness.144 Whenever a case of invasive Hib disease is identified, unvaccinated or incompletely vaccinated children 2 through 59 months of age who are household or day-care contacts of the infected individual should receive a dose of Hib vaccine and be scheduled to complete the recommended age-specific Hib vaccination schedule.105

If a case of Hib is diagnosed, rifampin postexposure prophylaxis is recommended for all household contacts (regardless of age) in households with children younger than 4 years of age who are unvaccinated or incompletely vaccinated against Hib and for all household contacts in households with an immunocompromised individual younger than 18 years of age.105,159 In childcare settings, rifampin postexposure prophylaxis is recommended for all attendees and all childcare providers if 2 or more cases of invasive Hib disease have occurred within 60 days and unvaccinated or incompletely vaccinated children attend the facility.105,159 Rifampin eradicates nasopharyngeal carriage of Hib in approximately 95% of carriers and decreases the risk of secondary invasive disease in exposed household contacts.105 (See Uses: Prevention of Haemophilus influenzae type b Infection, in Rifampin 8:16.04.)

Dosage and Administration ⬆ ⬇

[Section Outline]

Reconstitution and Administration
Dosage

Reconstitution and Administration

Haemophilus b (Hib) conjugate vaccine (meningococcal protein conjugate) (PRP-OMP; PedvaxHIB^®)144 and Hib conjugate vaccine (tetanus toxoid conjugate) (PRP-T; ActHIB^®, Hiberix^®)174,223 are administered by IM injection.

The combination vaccine containing diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DTaP), poliovirus vaccine inactivated (IPV), and Hib conjugate vaccine (DTaP-IPV/Hib; Pentacel^®)224 is administered by IM injection.224

Monovalent Hib vaccine and combination vaccine containing Hib and other antigens should not be given IV, subcutaneously, or intradermally.144,174,223,224

Syncope (vasovagal or vasodepressor reaction; fainting) may occur following vaccination;134,223 such reactions may be accompanied by transient neurologic signs (e.g., visual disturbance, paresthesia, tonic-clonic limb movements).223 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.134,223 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

Hib vaccine may be given concurrently with other age-appropriate vaccines.105,134 When multiple vaccines are administered during a single health-care visit, each parenteral vaccine should be given using separate syringes and different injection sites.105,134 The 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.134,144,174,223,224

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 preferred;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 IM injections also 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, the thickness of adipose tissue and muscle at the injection site, and the injection technique.134,208,209 Anatomic variability, especially in the deltoid, should be considered and clinical judgment should be used to avoid inadvertent underpenetration or overpenetration of muscle.134,208,209

Some manufacturers state that Hib vaccine should not be injected into the gluteal area or any area where there may be a major nerve trunk.144,224

PRP-OMP (PedvaxHIB®)

PRP-OMP (PedvaxHIB^®) is administered undiluted.144

Single-dose vials of PRP-OMP should be shaken well prior to withdrawing the dose.144 Thorough agitation is necessary to maintain a suspension;144 the vaccine should appear as a slightly opaque white suspension.144

PRP-T (ActHIB®)

Single-dose vials of lyophilized PRP-T (ActHIB^®) should be reconstituted by adding 0.6 mL of the 0.4% sodium chloride diluent supplied by the manufacturer.174 The vial should be agitated thoroughly to ensure complete reconstitution;174 the reconstituted vaccine should appear clear and colorless.174 The manufacturer's labeling should be consulted for additional information regarding reconstitution of PRP-T.174

PRP-T should be administered promptly after reconstitution or may be stored at 2-8°C and administered within 24 hours after reconstitution.174 The reconstituted vaccine should be shaken well prior to use.174

PRP-T should not be mixed with any other vaccine or solution.174

PRP-T (Hiberix®)

Single-dose vials of lyophilized PRP-T (Hiberix^®) should be reconstituted by adding the entire amount of 0.9% sodium chloride diluent supplied by the manufacturer.223 The vial should be agitated thoroughly to ensure complete reconstitution.223 The manufacturer's labeling should be consulted for additional information regarding reconstitution of PRP-T.223

PRP-T should be administered promptly after reconstitution or may be stored at 2-8°C and administered within 24 hours after reconstitution.223 The reconstituted vaccine should be shaken well prior to use.223

PRP-T should not be mixed with any other vaccine or solution.223

DTaP-IPV/Hib (Pentacel®)

DTaP-IPV/Hib (Pentacel^®) is commercially available as a kit containing a single-dose vial of a fixed-combination vaccine containing diphtheria, tetanus, pertussis, and poliovirus antigens (DTaP-IPV vaccine) and a single-dose vial of lyophilized Hib vaccine (PRP-T; ActHIB^®).224

Prior to administration, the vial of lyophilized PRP-T vaccine from the kit should be reconstituted by adding the entire contents of the vial of the DTaP-IPV vaccine from the kit according to manufacturer's instructions to provide a combination vaccine containing diphtheria, tetanus, pertussis, IPV, and Hib antigens.224 The vial should be gently swirled until a cloudy, uniform, white to off-white (yellow tinge) suspension is obtained.224

DTaP-IPV/Hib should be administered immediately after reconstitution.224

Dosage

The dosage schedule (i.e., number of doses) recommended for primary immunization against Hib infection varies according to the specific Hib vaccine administered and the age at which vaccination is started.144,159,174,223 The age-appropriate recommendations for the specific preparation used should be followed. 144,159,174,223

Monovalent PRP-OMP and monovalent PRP-T are considered interchangeable for both primary and booster immunization.105,159,166 If the primary immunization series included both PRP-OMP and PRP-T or if there is uncertainty about which vaccine type was administered previously, 3 primary doses and a booster dose are needed to complete the series.105,159,166

The US Public Health Service Advisory Committee on Immunization Practices (ACIP) and American Academy of Pediatrics (AAP) state that PRP-OMP is preferred for primary immunization in American Indian and Alaskan native children.105,159 (See Uses: Choice of Hib Vaccines.)

Medically stable preterm infants should be vaccinated at the usual chronologic age using usual dosage.105,144,159 (See Cautions: Pediatric Precautions.)

If interruptions or delays result in an interval between Hib vaccine doses longer than recommended, it is not necessary to administer additional doses or start the vaccination series over.134,144 Such interruptions should not reduce the final level of antibodies produced or interfere with final immunity achieved, although protection may not be attained until all recommended doses have been administered.134

PRP-OMP (PedvaxHIB®)

PRP-OMP (PedvaxHIB^®) is administered IM in 0.5-mL doses.144

PRP-OMP is labeled by FDA for use in infants and children 2 through 71 months of age.144

Routine primary immunization in early infancy using PRP-OMP consists of a series of 2 doses and a booster dose.105,144,199 The manufacturer, ACIP, AAP, and other experts recommend that doses be given at 2, 4, and 12 through 15 months of age.144,199 The initial dose may be given as early as 6 weeks of age.199 The minimum interval between the first and second doses is 2 months (8 weeks).144,199 A third dose (booster dose) of PRP-OMP should be given no earlier than 2 months after the second dose and is necessary only if the second dose of PRP-OMP was administered before 12 months of age.144,159

For catch-up immunization in infants who receive the first dose of Hib vaccine at 7 through 11 months of age, ACIP, AAP, and other experts recommend that a second dose be given at least 4 weeks after the first dose and that a third dose be given at 12 through 15 months of age or 8 weeks after the second dose, whichever is later.159,199

For catch-up immunization in previously unvaccinated infants 12 through 14 months of age, ACIP, AAP, and other experts recommend that 2 doses be given;159,199 the first dose should be given immediately and a second dose should be given 8 weeks after the first dose.159,199 A third dose is not necessary.159

In previously unvaccinated infants and children 15 through 59 months of age, ACIP, AAP, and other experts recommend that a single dose of Hib vaccine be given.199

PRP-T (ActHIB®)

PRP-T (ActHIB^®) is administered IM in 0.5-mL doses.174 This PRP-T vaccine is labeled by FDA for use in infants and children 2 months through 5 years of age.174

Routine primary immunization in early infancy using PRP-T consists of a series of 3 doses and a booster dose.105,159,174,199 ACIP, AAP, and other experts recommend that doses be given at 2, 4, 6, and 12 through 15 months of age.105,199 The manufacturer recommends that doses be given at 2, 4, 6, and 15 through 18 months of age.174 The initial dose may be given as early as 6 weeks of age.105,159,174,199

In previously unvaccinated infants and children 15 through 59 months of age, ACIP, AAP, and other experts recommend that a single dose of Hib vaccine be given.199

PRP-T (Hiberix®)

PRP-T (Hiberix^®) is administered IM in 0.5-mL doses.223 This PRP-T is labeled by FDA for use in infants and children 6 weeks through 4 years of age.223

Routine primary immunization in early infancy using PRP-T consists of a series of 3 doses and a booster dose.199,223 ACIP, AAP, and other experts recommend that doses be given at 2, 4, 6, and 12 through 15 months of age.199 The manufacturer recommends that doses be given at 2, 4, 6, and 15 through 18 months of age.223 The initial dose may be given as early as 6 weeks of age.199,223

In previously unvaccinated infants and children 15 through 59 months of age, ACIP, AAP, and other experts recommend that a single dose of Hib vaccine be given.199

DTaP-IPV/Hib (Pentacel®)

DTaP-IPV/Hib (Pentacel^®) is administered IM in 0.5-mL doses.224

DTaP-IPV/Hib is labeled by FDA for use in infants and children 6 weeks through 4 years of age.224

In previously unvaccinated infants or children 6 weeks through 4 years of age, DTaP-IPV/Hib is given in a series of 4 doses.224 ACIP, AAP, and other experts recommend that doses be given at 2, 4, 6, and 12 through 15 months of age.105,199 The manufacturer recommends that doses be given at 2, 4, 6, and 15 through 18 months of age.224 The initial dose usually is given at 2 months of age, but may be given as early as 6 weeks of age.224

In infants or children 6 weeks through 4 years of age who previously received 1 or more doses of Hib vaccine, DTaP-IPV/Hib can be used to complete the Hib vaccination series when doses of IPV and DTaP also are indicated and there are no contraindications to any of the individual components.207,224

To complete the recommended primary and booster vaccination series against diphtheria, tetanus, and pertussis, children who received the 4-dose series of DTaP-IPV/Hib (Pentacel^®) should receive a fifth dose of DTaP (Daptacel^®) at 4 through 6 years of age.224 DTaP-IPV/Hib should not be used for the booster dose of DTaP indicated at 4 through 6 years of a however, if a dose of DTaP-IPV/Hib is inadvertently given to a child 5 years of age or older, ACIP states the dose may be counted as a valid dose.207

To complete vaccination against poliovirus in children who received the 4-dose series of DTaP-IPV/Hib at 2, 4, 6, and 15 through 18 months of age, an additional booster dose of age-appropriate vaccine containing IPV (IPOL^® or Kinrix^®) should be given at 4 through 6 years of age.224

Cautions ⬆ ⬇

[Section Outline]

PRP-OMP (PedvaxHIB®)
PRP-T (ActHIB®)
PRP-T (Hiberix®)
DTaP-IPV/Hib (Pentacel®)
Precautions and Contraindications
Pediatric Precautions
Geriatric Precautions
Mutagenicity and Carcinogenicity
Pregnancy, Fertility, and Lactation

Adverse reactions generally are mild and transient following administration of haemophilus b (Hib) vaccines7,8,144,174 and rarely persist longer than 24-48 hours.174

PRP-OMP (PedvaxHIB®)

In infants 2-6 months of age who received haemophilus b (Hib) conjugate vaccine (meningococcal protein conjugate) (PRP-OMP; PedvaxHIB^®), adverse local effects included erythema (exceeding 2.5 cm in diameter) in 0.4-2% of vaccinees within 6-48 hours after the first or second dose and swelling/induration (exceeding 2.5 cm in diameter) in 1-3% within 6-48 hours after the first dose and in 1% within 6-48 hours after the second dose.144 Similar adverse effects have been reported when a third dose is given at 12-15 months of age.144 Urticaria, pain, soreness, and sterile abscess at the injection site have been reported rarely with PRP-OMP.144

In infants 2-6 months of age who received PRP-OMP (PedvaxHIB^®), fever (exceeding 38.3°C) occurred in 0.5-18% within 6-48 hours after the first dose and in 3-14% within 6-24 hours after the second dose.144 Although a causal relationship was not established, urticaria, tracheitis, thrombocytopenia, lymphadenopathy, angioedema, and seizures have been reported rarely in infants or children who received PRP-OMP.144

PRP-T (ActHIB®)

In a study in US children who received Hib conjugate vaccine (tetanus toxoid conjugate) (PRP-T; ActHIB^®) at 2, 4, 6, and 15-16 months of age concurrently with various other vaccines containing diphtheria, tetanus, pertussis, poliovirus, pneumococcal, or hepatitis B antigens administered at different injection sites, solicited systemic adverse effects occurring within 3 days after a dose included fussiness/irritability (54-76%), decreased activity/lethargy (24-51%), inconsolable crying (36-59%), and fever (9-16%).174

Other adverse effects reported during postmarketing experience in children who received this PRP-T include anaphylaxis, other hypersensitivity reactions (e.g., rash, pruritus, urticaria, angioedema), seizures, extensive limb swelling, and peripheral edema.174

PRP-T (Hiberix®)

Adverse effects reported in at least 20% of children who received PRP-T (Hiberix^®) in clinical studies were pain and redness at the injection site, irritability, drowsiness, fever, loss of appetite, fussiness, and restlessness.223

In a clinical study in US children who received this PRP-T at 2, 4, and 6 months of age concurrently with various other vaccines containing diphtheria, tetanus, pertussis, hepatitis B, pneumococcal, poliovirus, and rotavirus antigens, solicited adverse effects occurring within 4 days after each dose were local effects, including pain (43-49%), redness (19-29%), and swelling (13-19%), and systemic effects, including irritability (67-70%), drowsiness (49-60%), loss of appetite (28-29%), and fever (14-19%).223

In a clinical study in US children who received primary immunization with a 3-dose series of this PRP-T given at 2, 4, and 6 months of age and then received a booster dose of the vaccine at 15-18 months of age administered concurrently with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DTaP) at a different injection site, solicited adverse effects occurring within 4 days after the booster dose were local effects, including pain (41%), redness (30%), and swelling (18%), and systemic effects, including irritability (58%), drowsiness (39%), loss of appetite (28%), and fever (15%).223

In an open-label, multicenter study in infants (mean age 16 months) who received a booster dose of this PRP-T concurrently with a combination vaccine containing diphtheria, tetanus, pertussis, hepatitis B, and poliovirus antigens (DTaP-HBV-IPV) administered at a different injection site, solicited adverse effects occurring within 4 days of vaccination were local effects, including redness (25%), pain (21%), and swelling (15%), and systemic effects, including fever (35%), fussiness (26%), loss of appetite (23%), restlessness (22%), sleepiness (20%), diarrhea (15%), and vomiting (5%).223

Other adverse effects that have been reported to have a plausible causal connection to this PRP-T include local effects (extensive swelling of the vaccinated limb, injection site induration), hypersensitivity reactions (anaphylaxis, anaphylactoid reaction, angioedema, rash, urticaria), nervous system effects (seizures with or without fever, hypotonic-hyporesponsive episode, somnolence, syncope or vasovagal response to the injection), and apnea.223

DTaP-IPV/Hib (Pentacel®)

In a clinical study in infants who received a 4-dose primary immunization series (at 2, 4, 6, and 15-16 months of age) of either the combination vaccine containing diphtheria, tetanus, pertussis, poliovirus, and Hib antigens (DTaP-IPV/Hib; Pentacel^®) or control vaccines (IPV, DTaP [Daptacel^®], and Hib [ActHIB^®] at 2, 4, and 6 months and Daptacel^® and ActHIB^® at 15-16 months) administered concurrently at separate injection sites, adverse effects occurring within 3 days of vaccination were solicited from parents and included local injection site reactions (redness, swelling, tenderness, increase in arm circumference) and systemic effects (fever, decreased activity/lethargy, inconsolable crying, fussiness/irritability).224 All infants also received hepatitis B vaccine (at 2 and 6 months) and pneumococcal 7-valent conjugate vaccine (at 2, 4, and 6 months) concurrently at different injection sites.224

The incidence of swelling or tenderness at the injection site in those who received DTaP-IPV/Hib was 5-10 or 39-56%, respectively, and was similar to that reported with DTaP vaccine alone (4-10 or 38-51%, respectively).224

The incidence of fever (38°C or higher) after the first, second, and third dose was 6, 11, and 16%, respectively, after the fixed-combination vaccine and 9, 16, and 16%, respectively, when the doses of DTaP, IPV, and Hib vaccines were given separately at different injection sites.224 The incidence of inconsolable crying or fussiness/irritability was 47-59 or 68-77%, respectively, after the fixed-combination vaccine compared with 48-59 or 67-76%, respectively, when the doses of DTaP, IPV, and Hib vaccine were given separately at different injection sites.224

Precautions and Contraindications

Prior to administration of monovalent Hib vaccine containing PRP-OMP, monovalent Hib vaccine containing PRP-T, or combination Hib vaccine containing PRP-T, 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 or similar vaccines.144,174,223 (See Sensitivity Reactions under Cautions: Precautions and Contraindications.)

The patient and/or the patient's parent or guardian should be informed of the benefits and risks of immunization with Hib vaccine and should be provided with a copy of the appropriate Vaccine Information Statement (available at the CDC website [Web]).174,203,223 Patients and/or the patient's parent or guardian also should be instructed to report any severe or unusual adverse reactions to their health-care provider.174,203 Clinicians or individuals can report any adverse reactions that occur following vaccination to VAERS at 800-822-7967 or [Web].174,203

PRP-OMP (PedvaxHIB^®) is contraindicated in individuals hypersensitive to any vaccine component.144

PRP-T (ActHIB^®, Hiberix^®) is contraindicated in individuals who have had a severe allergic reaction (e.g., anaphylaxis) after a dose of any Hib vaccine, a dose of any vaccine containing tetanus toxoid, or any component in PRP-T.174,223

DTaP-IPV/Hib (Pentacel^®) is contraindicated in individuals with severe allergic reaction (e.g., anaphylaxis) to any ingredient in the vaccine or after a previous dose of the vaccine or any vaccine containing diphtheria, tetanus, pertussis, poliovirus, or Hib antigens.224 In addition, because of the pertussis antigen, DTaP-IPV/Hib (Pentacel^®) is contraindicated in individuals who had encephalopathy (e.g., coma, decreased consciousness, prolonged seizures) within 7 days of a dose of pertussis-containing vaccine and in individuals with progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy.224

Although PRP-OMP contains Hib antigen conjugated to the outer membrane protein complex (OMPC) of Neisseria meningitidis and antibodies to OMPC have been demonstrated in patients who received the vaccine, the clinical relevance of these antibodies has not been established.144 PRP-OMP (PedvaxHIB^®) should not be considered an immunizing agent against meningococcal disease.159

Although PRP-T contains Hib antigen conjugated to tetanus toxoid, PRP-T vaccines are not a substitute for routine immunization against tetanus.174,223

Sensitivity Reactions

Prior to administration of Hib vaccine, clinicians should review the patient's history regarding possible sensitivity and any previous adverse reactions and should take all precautions known for prevention of allergic or any other adverse effects.144,174,223

Epinephrine and other appropriate agents and equipment should be available for immediate treatment if an anaphylactic or other serious allergic reaction occurs.144,174,223

Latex Sensitivity

Some packaging components of PRP-OMP (PedvaxHIB^®) (i.e., vial stoppers) contain natural rubber latex144 which may cause sensitivity reactions in susceptible individuals.144,190,192 Delayed-type (cell-mediated) allergic contact dermatitis is the most common type of latex hypersensitivity; however, immediate-type allergic reactions have been reported rarely.134

The US Public Health Service Advisory Committee on Immunization Practices (ACIP) states that vaccines supplied in vials or syringes that contain dry natural rubber or natural rubber latex may be administered to individuals with a history of contact allergy to latex.134 However, vaccines supplied in vials or syringes that contain natural rubber latex should be avoided, if possible, in individuals with a history of severe (anaphylactic) latex allergy;134 if used in such individuals, appropriate agents and equipment should be available to treat anaphylaxis or other immediate allergic reaction to latex.134

Neomycin and/or Polymyxin B Allergy

DTaP-IPV/Hib (Pentacel^®) contains trace amounts of neomycin sulfate (no more than 4 pg per 0.5-mL dose) and polymyxin B (no more than 4 pg per 0.5-mL dose).224

Neomycin hypersensitivity usually manifests as a delayed-type (cell-mediated) contact dermatitis.134

ACIP states that a history of delayed-type allergic reaction to neomycin is not a contraindication for administration of vaccines containing trace amounts of neomycin; however, individuals with a history of anaphylactic reaction to neomycin should be evaluated by an allergist before receiving a neomycin-containing vaccine.134

Individuals with Altered Immunocompetence

Like other inactivated vaccines, Hib vaccines may be administered to individuals immunosuppressed as a result of disease or medical therapy;105,134,135,144,156 however, immune responses to vaccines and efficacy may be reduced in individuals with altered immunocompetence.105,134,135,144,174,223

The manufacturer of PRP-T (Hiberix^®) monovalent Hib vaccine states that safety and efficacy of the vaccine have not been evaluated in immunosuppressed children.223

Immune responses have been obtained following administration of Hib vaccine in patients with sickle disease, leukemia, or HIV infection, and in those who have undergone splenectomies;166 immune responses in HIV-infected individuals vary with the degree of immunocompromise.166

ACIP, American Academy of Pediatrics (AAP), US Centers for Disease Control and Prevention (CDC), National Institutes of Health (NIH), HIV Medicine Association of the Infectious Diseases Society of America (IDSA), and other experts state that recommendations regarding use of Hib vaccine in HIV-infected children are the same as those for children who are not infected with HIV.156 (See HIV-infected Individuals under Primary and Booster Immunization: Individuals at Increased Risk Because of Certain Medical Conditions, in Uses.)

AAP states that children who have received the usual age-appropriate regimen of Hib vaccine (primary and booster doses) and have decreased or absent splenic function do not need additional doses of Hib vaccine; however, those who are scheduled for splenectomy (e.g., for Hodgkin's disease, spherocytosis, immune thrombocytopenia, hypersplenism) may benefit from an additional dose of any Hib vaccine given at least 14 days before surgery.105 (See Anatomic or Functional Asplenia and Sickle Cell Disease under Primary and Booster Immunization: Individuals at Increased Risk Because of Certain Medical Conditions, in Uses.)

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

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 administration of the vaccine.134

Guillain-Barré Syndrome

If Guillain-Barré syndrome (GBS) occurred within 6 weeks of receipt of a vaccine containing tetanus toxoid, the manufacturers state that a decision to administer a dose of PRP-T (ActHIB^®, Hiberix^®) should be based on careful consideration of potential benefits and possible risks.174,223

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

Use of Combination Vaccines

When the combination vaccine containing diphtheria, tetanus, pertussis, poliovirus, and Hib antigens (DTaP-IPV/Hib; Pentacel^®) is used, the cautions, precautions, and contraindications associated with each antigen should be considered.224 (See Cautions in Poliovirus Vaccine Inactivated 80:12 and see Cautions in Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed/Tetanus Toxoid and Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed 80:08.)

Limitations of Vaccine Effectiveness

Hib vaccines may not protect all vaccine recipients against invasive Haemophilus influenzae type b (Hib) disease.144,174

Hib vaccines will not provide protection against other types of H. influenzae (e.g., nonencapsulated [nontypeable] strains) or against other pathogens that cause meningitis, septicemia, or other invasive disease.144

Hib vaccine does not result in protective antibodies immediately following vaccination.144

There is some evidence that vaccines containing PRP-OMP (PedvaxHIB^®) result in more rapid seroconversion to protective antibody concentrations within the first 6 months of life compared with vaccines containing PRP-T (ActHIB^®, Hiberix^®).105 This is particularly important in American Indian and Alaskan native children because these children are at increased risk for Hib disease during the first 6 months of life.105,159 (See Uses: Choice of Hib Vaccines.)

Although PRP-OMP contains Hib antigen conjugated to outer membrane protein complex (OMPC) of Neisseria meningitidis and antibodies to OMPC have been demonstrated in individuals who received the vaccine, the clinical relevance of these antibodies not established.144 PRP-OMP is not an immunizing agent against meningococcal disease.159

Although PRP-T contains Hib antigen conjugated to tetanus toxoid, the vaccine is not a substitute for routine immunization against tetanus.223

Improper Storage and Handling

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

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

Monovalent Hib vaccines or combination vaccines containing Hib and other antigens that have been mishandled or have not been stored at the recommended temperature should not be administered.134,144,174

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

PRP-OMP (PedvaxHIB^®): Safety and efficacy have not been established in infants younger than 6 weeks of age or in children 6 years of age or older.144 The manufacturer states that administration of PRP-OMP before 6 weeks of age may result in immunologic tolerance to the vaccine (i.e., impaired ability to respond to subsequent exposure to PRP antigen).144

PRP-T (ActHIB^®): Safety and efficacy have not been established in infants younger than 6 weeks of age.174

PRP-T (Hiberix^®): Safety and efficacy have not been established in infants younger than 6 weeks of age or in children and adolescents 5-16 years of age.223

DTaP-IPV/Hib (Pentacel^®): Safety and efficacy have not been established in infants younger than 6 weeks of age or in children 5-16 years of age.224

ACIP and AAP state that immunization against Hib infection using an age-appropriate vaccine can be initiated as early as 6 weeks of age.105,159,199 Hib vaccines should not be administered to infants younger than 6 weeks of age.144,159

Apnea has been reported following IM administration of vaccines in some infants born prematurely.223,224 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.223,224

Geriatric Precautions

Safety and efficacy of Hib vaccines have not been established in adults, including geriatric adults,144,223 and these vaccines are not usually used in this age group.105,144,159,200 (See Adults and Children 5 Years of Age or Older under Uses: Primary and Booster Immunization.)

Mutagenicity and Carcinogenicity

Studies have not been performed to date to evaluate the mutagenic or carcinogenic potential of Hib vaccines.144,174,223

Pregnancy, Fertility, and Lactation

Pregnancy

Hib vaccines are not labeled by FDA for use in adolescents or adults,144,177,223 and these vaccines are not usually used in this age group.93,105,159,200 (See Adults and Children 5 Years of Age or Older under Uses: Primary and Booster Immunization.)

Animal reproduction studies have not been performed with Hib vaccines.174,223,224 It is not known whether the vaccines can cause fetal harm when administered to pregnant women or whether they can affect fertility.144,174,223,224

It is not known whether Hib capsular antigens contained in Hib vaccines cross the placenta.90 In one study, neonates born to women who received unconjugated Hib vaccine (no longer commercially available in the US) at 34-36 weeks' gestation had approximately 100-fold increases in cord blood anticapsular antibody levels compared with neonates born to women who did not receive the vaccine.103 Anticapsular antibody levels remained elevated for 12 months in the infants whose mothers were vaccinated during pregnancy.103 Serum Hib anticapsular antibody levels in these neonates were approximately 30% of levels reported in the mother.103

ACIP states that there is no evidence of risk to the fetus if inactivated vaccines are administered during pregnancy.134

Lactation

Hib vaccines are not labeled by FDA for use in adolescents or adults,144,174,223,224 and these vaccines are not usually used in this age group.93,105,159,200 (See Adults and Children 5 Years of Age or Older under Uses: Primary and Booster Immunization.)

It is not known whether antigens contained in Hib vaccines are distributed into milk, affect human milk production, or affect the breast-fed infant.223

In one study, Hib anticapsular antibody was distributed into milk of lactating women who received unconjugated Hib vaccine (no longer commercially available in the US) during the third trimester of pregnancy;96 anticapsular antibody levels in the milk of these women were 20 times higher than levels in the milk of women who received the vaccine prior to or following pregnancy.96 Antibodies to Hib capsular polysaccharide have been detected in the milk of nursing women who have natural immunity to Hib disease.53

ACIP states that administration of an inactivated vaccine to a woman who is breast-feeding does not pose any safety concerns for the woman or the breast-fed infant.134

Drug Interactions ⬆ ⬇

[Section Outline]

Immune Globulins
Immunosuppressive Agents
Vaccines

Immune Globulins

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]) should not substantially impair the immune response to inactivated vaccines.134 The US Public Health Service Advisory Committee on Immunization Practices (ACIP) states that inactivated vaccines such as haemophilus b (Hib) 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 therapy) may have reduced immune responses to vaccines, including Hib vaccine.105,134,144,174,223,224

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 If Hib vaccine was administered to children younger than 5 years of age during or within 14 days of starting chemotherapy or radiation therapy, the child should be considered unimmunized and Hib vaccine doses should be repeated beginning at least 3 months following completion of such therapy if immune competence has been restored.105,134,135,159 Although administration of inactivated vaccines can be considered in children receiving maintenance chemotherapy, vaccine doses administered during such therapy should not be considered valid unless there is documentation of a protective antibody response.135 Individuals who received Hib vaccine more than 14 days prior to initiation of chemotherapy do not require revaccination.105,134,159

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 state that, if an inactivated vaccine is indicated in a patient with a chronic inflammatory illness who is receiving maintenance therapy with a biologic response modifier, the vaccine should not be withheld because of concern about exacerbation of the inflammatory illness.105,135

Corticosteroids given in greater than physiologic doses may reduce immune responses to vaccines, including Hib vaccine.134,174,223,224 ACIP and the American Academy of Pediatrics (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 Hib 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 of Hib vaccine with each antigen, concurrent administration with other age-appropriate vaccines, including live virus vaccines, toxoids, or inactivated or recombinant vaccines, during the same health-care visit is not expected to affect immunologic responses or adverse reactions to any of the preparations.105,134

Immunization with Hib vaccine can be integrated with immunization against diphtheria, tetanus, pertussis, hepatitis A, hepatitis B, influenza, measles, mumps, rubella, meningococcal disease, pneumococcal disease, poliovirus, rotavirus, and varicella.105,134 However, unless combination vaccines appropriate for the age and vaccination status of the recipient are used, each parenteral vaccine should be administered using separate syringes and different injection sites.105,134

Inactivated Vaccines and Toxoids

Diphtheria and Tetanus Toxoids and Pertussis Vaccines

Monovalent Hib conjugate vaccine (meningococcal protein conjugate) (PRP-OMP; PedvaxHIB^®) and monovalent Hib conjugate vaccine (tetanus toxoid conjugate) (PRP-T; ActHIB^®, Hiberix^®) can be administered concurrently with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DTaP) using separate syringes and different injection sites without a decrease in the antibody response or an increase in adverse reactions to either vaccine.17,18,111,134,144,157,174,179,223 Alternatively, Hib vaccine is commercially available in a combination vaccine with DTaP, poliovirus vaccine inactivated (IPV), and Hib vaccine (DTaP-IPV/Hib; Pentacel^®).224 Depending on the age and vaccination status of the child, this combination vaccine can be used instead of separate injections of Hib vaccine and DTaP vaccine when indicated and if there are no contraindications to any of the individual components.224 (See Combination Vaccines Containing Hib Vaccine and Other Antigens under Uses: Choice of Hib Vaccines.)

PRP-T (Hiberix^®) has been administered concurrently with the fixed-combination vaccine containing diphtheria, tetanus, pertussis, hepatitis B, and poliovirus antigens (DTaP-HepB-IPV; Pediarix^®) and pneumococcal 13-valent conjugate vaccine (PCV13; Prevnar^® 13) in infants 2, 4, and 6 months of age without a reduced antibody response to DTaP or any of the other antigens.223 Concurrent administration of a booster dose of PRP-T (Hiberix^®) and DTaP at different injection sites in children 15-18 months of age did not affect antibody responses to DTaP.223

Hepatitis A Vaccine

In clinical studies in children 15 months of age who received hepatitis A virus vaccine inactivated (Havrix^®, Vaqta^®) and Hib vaccine concurrently at different injection sites (with or without other concurrent vaccines), immune responses and adverse effects were similar to those reported when the vaccines were administered at different times.76,198

Hepatitis B Vaccine

Although specific data are not available, monovalent Hib vaccine may be given concurrently with hepatitis B vaccine (using separate syringes and different injection sites).105,134,163,223 Extemporaneous vaccine combinations of Hib vaccine and hepatitis B vaccine should not be prepared by admixing commercially available monovalent Hib vaccine and monovalent hepatitis B vaccine.163

Pneumococcal Vaccines

Hib vaccine has been administered concurrently with PCV13; (Prevnar 13^®) using a separate syringe at a different injection site.134,223

Hib vaccine may be administered concurrently with pneumococcal 23-valent polysaccharide vaccine (PPSV23; Pneumovax^®) using separate syringes and different injection sites.105,134

Poliovirus Vaccine

Monovalent PRP-OMP or monovalent PRP-T may be administered concurrently with IPV using separate syringes and different injection sites.105,134,159 Alternatively, Hib vaccine is commercially available in combination with DTaP and IPV (DTaP-IPV/Hib; Pentacel^®).224 Depending on the age and vaccination status of the child, this combination vaccine can be used instead of separate injections of Hib vaccine and IPV vaccine when indicated and if there are no contraindications to any of the individual components.224 (See Combination Vaccines Containing Hib Vaccine and Other Antigens under Uses: Choice of Hib Vaccines.)

Live Vaccines

Measles, Mumps, and Rubella Virus Vaccine Live

Concurrent administration of measles, mumps, and rubella virus vaccine live (MMR) and Hib vaccine does not interfere with the immune response or increase adverse effects of either vaccine.174 Hib vaccine and MMR vaccine may be administered concurrently (using separate syringes and different injection sites).105,134,159

Rotavirus Vaccines

Rotavirus vaccine (Rotarix^®, RotaTeq^®) has been administered concurrently with Hib vaccines without a decrease in immune response to either vaccine.219,221,222

Varicella Virus Vaccine Live

Although specific studies are not available, ACIP and AAP state that Hib vaccine may be administered concurrently with varicella virus vaccine live.42,43,105,134 Results of a retrospective cohort study that used data from the Vaccine Safety Datalink (VSD) project and included children 12 months of age or older who were vaccinated during January 1995 to December 1999 indicate that administration of varicella virus vaccine live concurrently with or less than 30 days after Hib vaccine did not increase the risk of breakthrough varicella infections.32

Other Information ⬆ ⬇

[Section Outline]

Haemophilus influenzae Type b Infection
Response to Conjugated Haemophilus b Vaccines
Chemistry
Stability

Laboratory Test Interferences

Haemophilus b (Hib) vaccines potentially may interfere with interpretation of antigen detection tests such as latex agglutination and countercurrent immunoelectrophoresis that are used for diagnosis of systemic Hib disease.88,93,223 Antigenuria resulting from administration of unconjugated Hib vaccine (no longer commercially available in the US) in one child produced positive urinary latex agglutination tests for 7 days following immunization and initially obscured a diagnosis of aseptic meningitis in this patient.88 Hib capsular polysaccharide has also been detected in urine following administration of Hib conjugate vaccine.223 Therefore, urine antigen detection may not have diagnostic value in evaluating suspected Hib disease in children if performed within 1-2 weeks following administration of a Hib vaccine.88,93,223 Antigen testing of urine and serum specimens is no longer recommended for diagnosis of Hib infection.105,166

Pharmacology

Haemophilus b conjugate (meningococcal protein conjugate) vaccine (PRP-OMP) and haemophilus b conjugate (tetanus toxoid conjugate) vaccine (PRP-T) are used to stimulate active immunity to Haemophilus influenzae type b (Hib) infection by inducing production of specific antibodies.38,111,117,144,174,223 Hib capsular polysaccharide present in the vaccines promotes the production of Hib anticapsular antibody; evidence indicates that this antibody provides protection against infection with H. influenzae type b.6,7,14,38,55,59,75,117,128,174

Haemophilus influenzae Type b Infection

H. influenzae type b causes bacterial meningitis and other serious bacterial infections (e.g., pneumonia, epiglottitis, sepsis, cellulitis, septic arthritis, osteomyelitis, endocarditis, purulent pericarditis), especially in infants and children younger than 5 years of age.105,159,166 Nonencapsulated (nontypeable) strains of H. influenzae can also cause invasive disease, but usually cause mucosal infections such as otitis media, conjunctivitis, sinusitis, or bronchitis.105,159,166

Hib disease occurs worldwide.166 Prior to the availability of Hib vaccine, a child's cumulative risk of developing systemic Hib infection in the US during the first 5 years of life was about 0.5%.25,159 The peak incidence of invasive Hib infections occurs between 6 and 18 months of age.105,166 Children younger than 3-6 months of age may have protection against Hib disease, possibly as a result of passively acquired maternal antibodies and/or antibodies acquired from breast milk.31,53,83,166

Hib is transmitted from person to person, presumably by inhalation of respiratory tract droplets or by direct contact with respiratory tract secretions.105,159,166 Hib transiently colonizes the nasopharynx in some individuals without causing symptoms (asymptomatic carrier).105,166 In other individuals, Hib causes an invasive infection.105,159,166 Appropriate anti-infective therapy reduces the mortality from Hib meningitis,14,24,55 but long-term neurologic sequelae (e.g., mental retardation, deafness, blindness, seizure disorders, behavioral disorders, decreased school performance) occur in some survivors.14,25,50,55,70,159

Response to Conjugated Haemophilus b Vaccines

Hib capsular polysaccharide contained in Hib vaccines promotes the formation of Hib anticapsular antibody.105,144,159,174,223,166 All currently available Hib vaccines contain Hib capsular polysaccharide covalently bound to carrier protein antigens (tetanus toxoid or Neisseria meningitidis outer membrane protein complex [OMP]).144,159,166,174,223,224 These conjugated Hib vaccines induce an enhanced antibody response against Hib infection compared with that induced by unconjugated Hib vaccine (no longer commercially available in the US).9,11,18,21,22,29,30,37,61,62,63,64,87,106,111,117,129,166 This increased immunogenicity occurs because the carrier protein antigens (tetanus toxoid or OMP) confer T-lymphocyte-dependent (T-dependent) features to the polysaccharide antigen.129,144,174,166 T-dependent antigens induce an immune response that is predominantly IgG and potentially boostable following repeat doses.129,174,166

Studies using unconjugated Hib vaccines (no longer commercially available in the US) indicate that antibody titers to H. influenzae capsular polysaccharide (anti-PRP) of 1 mcg/mL or greater after vaccination correlate with long-term protection against invasive Hib disease.166,174,223

Twofold or greater increases in Hib anticapsular antibody levels compared with prevaccination levels have been observed in children 2-17 months of age following administration of 1-3 doses of various conjugated Hib vaccines.9,11,18,21,22,29,30,37,61,62,63,64,87,106 Booster responses have been observed following administration of a dose of conjugated Hib vaccine in children 15 through 18 months of age who previously received primary immunization with a Hib capsular polysaccharide/protein antigen combination.61,223

In a clinical study using PRP-OMP (PedvaxHIB^®), 80% of infants developed protective antibody levels (anti-PRP greater than 1 mcg/mL) after a primary series of 2 doses initiated at 2-3 months of age and 95% had protective antibody levels approximately 1 month after a booster dose given at 12-15 months of age.144

In clinical studies using PRP-T (ActHIB^®, Hiberix^®), 81-97% of infants developed protective antibody levels (anti-PRP 1 mcg/mL or greater) after a primary immunization series of 3 doses given at 2, 4, and 6 months of age174,223 and 98-100% had protective antibody levels 1 month after a booster dose given at 15-23 months of age.174,223

When a complete vaccination series is administered as recommended, regimens that include PRP-OMP or PRP-T are considered equivalent.105,159 However, there is some evidence that vaccines containing PRP-OMP result in more rapid seroconversion to protective antibody concentrations within the first 6 months of life compared with vaccines containing PRP-T.105 This is particularly important in American Indian and Alaskan native children because these children are at increased risk for Hib disease during the first 6 months of life.105 (See Uses: Choice of Hib Vaccines.)

Chemistry and Stability

Chemistry

Haemophilus b (Hib) conjugate vaccines are noninfectious, bacteria-derived vaccines containing antigenic capsular polysaccharide extracted from Haemophilus influenzae type b.144,159,174,223 The vaccine capsular polysaccharides are derived from polyribosylribitol phosphate (PRP), a major Hib virulence factor.159,166 Hib conjugate vaccines are commercially available as the polysaccharide conjugate of Neisseria meningitidis outer membrane protein complex (PRP-OMP; PedvaxHIB^®)129,144,148,159,160 or as the polysaccharide conjugate of tetanus toxoid (PRP-T; ActHIB^®) (PRP-T; Hiberix^®).174,223 These conjugated vaccines differ in the protein carrier, polysaccharide size, and method of conjugation, including use of a spacer (linking moiety) between the PRP and protein carrier.129,159

Hib Conjugate Vaccine (Meningococcal Protein Conjugate) (PRP-OMP; PedvaxHIB®)

Hib conjugate vaccine (meningococcal protein conjugate) (PRP-OMP) is a lyophilized preparation containing Hib capsular polysaccharide covalently bound to outer membrane protein complex (OMPC) of the B11 strain of N. meningitidis serogroup B.144 The capsular polysaccharide used in the preparation is PRP extracted from the Ross strain of Hib.144

PRP-OMP is commercially available as PedvaxHIB^®.144 PRP-OMP occurs as a slightly opaque, white suspension.144 Each 0.5-mL dose of PRP-OMP contains 7.5 mcg of purified Hib capsular polysaccharide, 125 mcg of N. meningitidis OMPC, and 225 mcg of aluminum as aluminum hydroxide in 0.9% sodium chloride.144 The vaccine does not contain thimerosal or any other preservative.144

Hib Conjugate Vaccine (Tetanus Toxoid Conjugate) (PRP-T; ActHIB®)

Hib conjugate vaccine (tetanus toxoid conjugate) (PRP-T; ActHIB^®) is a lyophilized preparation containing Hib capsular polysaccharide covalently bound to tetanus toxoid.174

The capsular polysaccharide contained in this PRP-T is prepared from Hib strain 1482;174 the tetanus toxoid conjugate is prepared by extraction, ammonium sulfate purification, and formalin inactivation of toxin from cultures of Clostridium tetani (Harvard strain) and is filter-sterilized prior to the conjugation process.174

Following reconstitution of this PRP-T with the 0.4% sodium chloride diluent provided by the manufacturer, the vaccine is clear and colorless and each 0.5-mL dose contains 10 mcg of purified Hib capsular polysaccharide, 24 mcg of tetanus toxoid, and 8.5% sucrose.174 PRP-T reconstituted with 0.4% sodium chloride diluent does not contain thimerosal or any other preservative.174

Hib Conjugate Vaccine (Tetanus Toxoid Conjugate) (PRP-T; Hiberix®)

Hib conjugate vaccine (tetanus toxoid conjugate) (PRP-T; Hiberix^®) is a lyophilized preparation containing Hib capsular polysaccharide covalently bound to tetanus toxoid.223

The capsular polysaccharide contained in this PRP-T (Hiberix^®) is prepared from Hib strain 20,752; the tetanus toxoid conjugate is prepared from cultures of C. tetani that are detoxified with formaldehyde and purified.223

Following reconstitution of this PRP-T with the 0.9% sodium chloride diluent provided by the manufacturer, the vaccine is clear and colorless and each 0.5-mL dose contains 10 mcg of purified Hib capsular polysaccharide, 25 mcg of tetanus toxoid, 12.6 mg of lactose, and 0.5 mcg or less of residual formaldehyde.223 PRP-T reconstituted with 0.9% sodium chloride diluent does not contain thimerosal or any other preservative.223

DTaP-IPV/Hib (Pentacel®)

A combination vaccine containing diphtheria, tetanus, pertussis, poliovirus, and Hib antigens (DTaP-IPV/Hib; Pentacel^®) is commercially available as a kit containing a fixed-combination liquid vaccine containing diphtheria, tetanus, pertussis, and poliovirus antigens (DTaP-IPV) and lyophilized Hib tetanus toxoid conjugate vaccine (PRP-T; ActHIB^®).224 The DTaP-IPV vaccine from the kit is used to reconstitute the PRP-T vaccine from the kit to provide a single vaccine containing antigens for all 5 diseases.224 The diphtheria, tetanus, and pertussis antigens are identical to those contained in Daptacel^® (DTaP) vaccine: however, the amounts of pertussis toxin (PT) and filamentous hemagglutinin (FHA) antigens in DTaP-IPV/Hib (Pentacel^®) are twofold and fourfold higher, respectively, than those contained in Daptacel^®.224 For information on these DTaP antigens, see Cautions in Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed/Tetanus Toxoid and Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed 80:08. For information on the poliovirus antigens, see Poliovirus Vaccine Inactivated 80:12.

Following reconstitution, each 0.5-mL dose of DTaP-IPV/Hib (Pentacel^®) contains 15 Lf of diphtheria toxoid, 5 Lf of tetanus toxoid, 48 mcg of pertussis antigens, 40 D antigen units (DU) of poliovirus type 1, 8 DU of poliovirus type 2, 32 DU of poliovirus type 3, and 10 mcg of Hib antigen.224 Each 0.5 mL of DTaP-IPV/Hib also contains 0.33 mg of aluminum adjuvant, approximately 10 ppm of polysorbate 80, less than 50 ng of residual glutaraldehyde, not more than 50 ng of residual bovine serum albumin, not more than 5 mcg of residual formaldehyde, and 3.3 mg of 2-phenoxyethanol.224 Although neomycin sulfate and polymyxin B are used in the manufacturing process of the poliovirus antigen component, DTaP-IPV/Hib contains less than 4 pg of each anti-infective per dose.224

Stability

Hib Conjugate Vaccine (Meningococcal Protein Conjugate) (PRP-OMP; PedvaxHIB®)

PRP-OMP (PedvaxHIB^®) should be refrigerated at 2-8°C and should not be frozen.144

Hib Conjugate Vaccine (Tetanus Toxoid Conjugate) (PRP-T; ActHIB®)

Lyophilized PRP-T (ActHIB^®) and the 0.4% sodium chloride diluent provided by the manufacturer should be refrigerated at 2-8°C and should not be frozen.174 The vaccine contains no preservatives.174

Following reconstitution with the sodium chloride diluent, this PRP-T should be used promptly.174 Alternatively, the reconstituted vaccine may be stored at 2-8°C and used within 24 hours after reconstitution.174

Hib Conjugate Vaccine (Tetanus Toxoid Conjugate) (PRP-T; Hiberix®)

Lyophilized PRP-T (Hiberix^®) should be stored at 2-8°C and protected from light.223 The 0.9% sodium chloride diluent supplied by the manufacturer should be stored at 2-8°C or at room temperature up to 25°C.223 The diluent should not be frozen and should be discarded if freezing occurs.223

Following reconstitution with the diluent provided by the manufacturer, this PRP-T should be stored at 2-8°C, used within 24 hours, and protected from freezing.223 The reconstituted vaccine should be discarded if it has been frozen or has not been used within 24 hours.223

DTaP-IPV/Hib (Pentacel®)

The commercially available kit containing a fixed-combination DTaP-IPV vaccine and lyophilized PRP-T (ActHIB^®) vaccine (DTaP-IPV/Hib; Pentacel^®) should be stored at 2-8°C and should not be frozen.224 If freezing occurs, the vaccines should be discarded.224

DTaP-IPV/Hib should be used immediately after reconstitution.224

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer's labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

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.

Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PRP-OMP)

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Injectable suspension, for IM use	7.5 mcg of Haemophilus b capsular polysaccharide conjugated to 125 mcg of Neisseria meningitidis OMPC protein carrier per 0.5 mL	PedvaxHIB^® Liquid	Merck

Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) (PRP-T)

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	For injectable suspension, for IM use	10 mcg of Haemophilus b capsular polysaccharide conjugated to 24 mcg of tetanus toxoid protein carrier per 0.5 mL	ActHIB^®	Sanofi Pasteur
	For injection, for IM use	10 mcg of Haemophilus b capsular polysaccharide conjugated to 25 mcg of tetanus toxoid protein carrier per 0.5 mL	Hiberix^®	GlaxoSmithKline

Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine (DTaP-IPV/Hib)

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Kit, for IM use	Injection, for IM use, Diphtheria Toxoid 15 Lf units, Tetanus Toxoid 5 Lf units, Acellular Pertussis Vaccine 48 mcg (of pertussis antigen), Poliovirus Type 1 40 DU, Poliovirus Type 2 8 DU, and Poliovirus Type 3 32 DU per 0.5 mL For injectable suspension, for IM use, 10 mcg of Haemophilus b polysaccharide conjugated to 25 mcg of tetanus toxoid protein carrier per 0.5 mL, ActHIB^®	Pentacel^®	Sanofi Pasteur

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

Kit, for IM use

Injection, for IM use, Diphtheria Toxoid 15 Lf units, Tetanus Toxoid 5 Lf units, Acellular Pertussis Vaccine 48 mcg (of pertussis antigen), Poliovirus Type 1 40 DU, Poliovirus Type 2 8 DU, and Poliovirus Type 3 32 DU per 0.5 mL

For injectable suspension, for IM use, 10 mcg of Haemophilus b polysaccharide conjugated to 25 mcg of tetanus toxoid protein carrier per 0.5 mL, ActHIB^®

Pentacel^®

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 ⬆ ⬇

Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PRP-OMP)

Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) (PRP-T)

Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine (DTaP-IPV/Hib)

Copyright ⬆ ⬇

References ⬆