Poliovirus Vaccine Inactivated

[Section Outline]

Past and Current Considerations Regarding US Poliovirus Vaccine Recommendations
Global Risks of Poliomyelitis Exposure and Infection
Primary Immunization
Outbreak Control

Poliovirus vaccine inactivated (IPV) is used to prevent poliomyelitis by stimulating active immunity to poliovirus types 1, 2, and 3.1,9,105,166,199

The US Public Health Service Advisory Committee on Immunization Practices (ACIP), American Academy of Pediatrics (AAP), and other experts recommend that all infants, children, and adolescents 17 years of age or younger receive primary immunization against poliomyelitis.9,105,166,199 Primary immunization against poliomyelitis is not routinely recommended for adults 18 years of age or older,1,105,166,200 unless they are at increased risk of exposure to poliovirus.1,9,105,115,166

IPV is the only poliovirus vaccine commercially available in the US.1,105,115,166 Although immunization regimens that used poliovirus vaccine live oral (OPV; no longer commercially available in the US) or sequential IPV/OPV regimens that used both types of vaccines were previously used for primary immunization against poliomyelitis in the US,9,105,154 an all-IPV regimen has been used for routine childhood immunization in the US since January 2000.1,9,154,166

Past and Current Considerations Regarding US Poliovirus Vaccine Recommendations

The first vaccine available for prevention of poliomyelitis was an inactivated virus vaccine that was licensed for use in the US in 1955.6,16,17,27,42,44,47,83,93,95,108,109,110,129,166 This initial poliovirus vaccine, known as the Salk vaccine, was an IPV formulation with lower potency than the currently available vaccine.16,17,27,42,43,83,93,95,109 Within 3-5 years after IPV was introduced, there was a dramatic decrease in the reported incidence of paralytic poliomyelitis in the US (18,308 cases in 1954 versus 988 cases in 1961).6,19,27,42,83,85 However, local epidemics still occurred and by 1959-1960 there was a slight resurgence of the disease and evidence of vaccine failure in some patients.27,48

An OPV vaccine, known as the Sabin vaccine, first became available for use in the US in 1960-1962 in monovalent forms; in 1963, trivalent OPV became available.6,13,15,20,27,42,44,47,83,84,95,108,109,129,166 Partly because the original (but not the current) IPV formulation was less than optimally potent and therefore not consistently immunogenic,19,42,43,48 OPV quickly replaced IPV as the poliomyelitis vaccine of choice for routine use in the US.15,17,19,20,27,35,83,84,93,95,96,108,109,166 Advantages of OPV include ease of administration, increased herd immunity through the spread of vaccine virus to unimmunized susceptible contacts of vaccine recipients, induction of intestinal immunity, and lower cost.7,15,17,19,45,83,84,93,96,108,110,129 The major disadvantage of OPV is the risk of vaccine-associated paralytic poliomyelitis (VAPP) in vaccine recipients and their susceptible contacts since OPV, unlike IPV, contains live virus.6,7,9,15,19,20,27,28,47,83,90,93,95,96,120,129,166 (See Uses: Global Risks of Poliomyelitis Exposure and Infection.) In addition, OPV has been associated with lower seroconversion rates when used in tropical and subtropical areas and adherence to particular storage requirements is necessary to preserve potency of the vaccine.6,7,15,19,20,27,28,43,44,47,70,83,93,95,96,120,129

In part because of concerns about OPV-related VAPP, research efforts during the 1980's focused on IPV formulations, and an enhanced-potency IPV formulation was first licensed for use in the US in 1987.15,95,109,166 Because the only form of poliomyelitis that had occurred within the US since 1987 was VAPP and because poliomyelitis caused by wild-type poliovirus had not been reported in the Western hemisphere since 1991 (see Uses: Global Risks of Poliomyelitis Exposure and Infection), many clinicians at that time began to support recommendations that placed greater emphasis on the use of IPV regimens or sequential IPV/OPV regimens for routine primary immunization since the inactivated vaccine is not associated with any known risk of VAPP.7,9,15,17,19,23,30,36,37,43,44,47,49,83,84,93,95,96,97,133,139,143 Other countries had achieved control of the disease with exclusive use of IPV (e.g., Sweden, Finland, Netherlands, most provinces in Canada) or with sequential regimens that employed both IPV and OPV (e.g., Denmark, Israel, Egypt).15,16,20,28,37,41,42,43,44,47,88,96,128,133,143 The rationale for use of a sequential IPV/OPV schedule is the theory that use of IPV for the initial dose(s) and OPV only for subsequent doses would reduce the risk of VAPP while ensuring both adequate humoral and intestinal immunity.8,11,17,19,20,27,43,49,96,97,128,133

There was much controversy, however, concerning use of sequential IPV/OPV regimens in the US.8,11,19,20,27,43,45,96,97,133 Some clinicians suggested that use of a sequential regimen that involves both types of vaccines for primary immunization was supported by the changing epidemiology of paralytic poliomyelitis (i.e., VAPP was the only form of the disease reported within the US), improvements in vaccine coverage among preschool and school-aged children, availability of enhanced potency IPV, and the increasing cost of OPV.8,17,19,20,96,97,133 These clinicians also suggested that a policy that relies exclusively on use of OPV for primary immunization of healthy children causes parents and children who cooperate with immunization recommendations to bear the risk of VAPP in order to spread the benefit of herd immunity to those who fail to have themselves or their children immunized.96 Other clinicians at that time suggested that sequential immunization regimens were difficult to administer, could be more costly than an OPV regimen,45,96,133 and, although the risk of VAPP may decrease with a sequential regimen, it would not be eliminated entirely.11,27,43,45,96,150 There also was concern that endemic transmission of wild-type poliomyelitis virus possibly could be enhanced with a sequential regimen since induction of intestinal immunity would be delayed secondary to administration of the first dose of OPV at an older age.11,27,43,45,96 Some clinicians also suggested that the effects of a sequential immunization regimen on herd immunity and on risk for contacts of vaccine recipients would depend on the influence of IPV on the excretion of virus after subsequent OPV and this was not been fully determined.11,12,27,45,96,128 (See Pharmacology: Response to IPV.)

Periodically over the years, specialists reexamined options for poliomyelitis prevention in the US and considered available data concerning safety and efficacy of IPV and OPV.6,7,15,17,19,44,45,84,96,97,108,109,133 In both 1977 and 1988, the Institute of Medicine (IOM) of the National Academy of Sciences, ACIP, and AAP recommended continued reliance on OPV for routine use in healthy children in the US and use of IPV in adults and immunodeficient individuals and their household or other close contacts.6,17,84,96,108,109 In June 1995, the IOM and a panel of experts from the US Centers for Disease Control and Prevention (CDC), AAP, and others again reviewed strategies for poliomyelitis prevention in the US and, although concerns were expressed about additional costs and the additional injections that would be necessary, many participants advocated a change to sequential use of IPV and OPV for routine primary immunization of healthy children in the US.130,133 Between 1997 and 1999, ACIP and AAP recommended use of a sequential IPV/OPV regimen for routine childhood immunization in healthy children as an interim policy to facilitate a transition to exclusive use of IPV regimens.150,154 This strategy was intended to decrease the incidence of VAPP while maintaining high levels of population immunity to polioviruses to prevent poliomyelitis outbreaks should wild-type poliovirus be reintroduced in the US.150,153,154

Beginning in January 2000, ACIP, AAP, and other experts recommended use of an all IPV regimen for routine primary immunization in infants and children in the US.1,9,154,166 This recommendation was based on the continuing (albeit rare) occurrence of VAPP, the decreasing risk of importation of wild-type poliomyelitis into the US, the acceptance of IPV by health-care professionals, and the probable lack of availability of OPV.9,154 Although OPV was the vaccine of choice for routine primary immunization of healthy children in the US for over 30 years,96,105,109 use of OPV was discontinued in the US in 2000.166 OPV is still used in some countries and is used as part of strategic eradication campaigns in areas of the world where wild-type poliovirus remains endemic or epidemic.9,105,115,154,159,166,180,184 (See Uses: Global Risks of Poliomyelitis Exposure and Infection.)

Global Risks of Poliomyelitis Exposure and Infection

Although wild-type poliovirus infection has been eliminated in the US because of effective poliovirus vaccine immunization programs,9,17,19,41,43,44,86,91,93,95,105,115,166 efforts are ongoing to eradicate poliomyelitis worldwide.9,115,182,183,184,186 Prior to the introduction of poliovirus vaccines, there were approximately 600,000 cases of paralytic poliomyelitis worldwide and at least 10,000-20,000 cases in the US each year.9,93,95,108,129

In 1988, the World Health Assembly adopted a resolution to eradicate poliovirus worldwide and launched the Global Polio Eradication Initiative (GPEI).169,183 At that time, poliomyelitis was endemic in more than 125 countries and an estimated 350,000 cases occurred annually worldwide.169,180 As the result of global efforts to eradicate the disease, the World Health Organization (WHO) declared the Americas (36 countries) to be polio-free in 1994, followed by the WHO western Pacific region (37 countries and areas including China) in 2000, the WHO European region (51 countries) in 2002,169 and the WHO South-East Asia Region (11 countries) in 2014.169 During 2014, a total of 359 wild-type poliovirus cases were reported worldwide;169,183 85% of these cases were detected in Pakistan, 8% in Afghanistan, and 2% in Nigeria.183 The remaining wild-type poliovirus cases reported in 2014 occurred in 6 polio-free countries in Central Africa, the Horn of Africa, and the Middle East as the result of importation of the virus.183 In October 2015, WHO stated that endemic transmission of wild-type poliovirus had been interrupted in all but 2 countries (Afghanistan and Pakistan).169

The last known cases of naturally occurring wild-type poliovirus infection reported within the US occurred among susceptible members of religious sects who had refused immunization against the disease (outbreaks occurred in 1972 among Christian Scientists and in 1979 among members of an Amish community).9,17,44,91,95,96,108,105,115,123,166 Between 1980 and 1986, there were 5 reported cases of wild-type poliovirus infection in the US that occurred as the result of travel to or immigration from areas that had endemic poliovirus at that time (i.e., Mexico, Haiti, Nepal, Burma, Zaire).95

The only form of poliomyelitis that has been reported within the US since 1986 has been VAPP.93,95,96,105 Between 1980 and 1989, there were 86 confirmed cases of paralytic poliomyelitis reported in the US and 93% of these were attributed to OPV.95 Of these OPV-related cases, 45% occurred in vaccine recipients (most were children younger than 1 year of age) and 48% occurred in contacts of recent OPV recipients.95 The majority of contact cases occurred among adult members of the vaccinee's family or among other close contacts (e.g., caregivers) who were unimmunized or incompletely immunized.17

VAPP is a rare event that can occur after administration of OPV, apparently as the result of the vaccine virus reverting to a neurovirulent form that can cause paralysis in the vaccine recipient or a nonimmune contact.166,184 VAPP results in paralysis that is identical to that caused by wild-type poliovirus and may be permanent.166 The overall risk of VAPP has been estimated to be 1 case per 2.4 million doses of OPV distributed.9 The risk for both vaccine recipients and their contacts is greater following the first dose of OPV than following any subsequent dose.9,166 The overall risk of VAPP has been estimated to be 1 case per 750,000 first doses of OPV and 1 case per 5.1 million subsequent doses.9 VAPP is more likely to occur in adults 18 years of age or older than in children and is more likely to occur in immunodeficient children than in immunocompetent children.166

In addition to cases of VAPP, use of OPV in worldwide poliomyelitis eradication programs has been associated with emergence of genetically divergent, neurovirulent vaccine-derived polioviruses (VDPVs).183,184 Circulating VDPVs (cVDPVs) resemble wild-type polioviruses and can cause paralytic poliomyelitis.183,184 Person-to-person transmission of cVDPVs can occur and outbreaks related to these strains have been reported in areas of the world with low poliovirus vaccination coverage.183,184 Efforts to identify VDPVs are now included in global surveillance for acute flaccid paralysis and environmental surveillance for polioviruses.183,184 Although wild-type poliovirus type 2 has not been detected worldwide since 1999,182,183,184 data indicate that the majority of cVDPVs identified during surveillance between 2006 and early 2015 are type 2 (88%), followed by type 1 (10%) and type 3 (2%).184 During this period, 686 cVDPV cases were reported worldwide and more than 97% of these were associated with cVDPV type 2.184

In an effort to finally eliminate polio worldwide and in recognition of the ongoing risk of cVDPVs with continued use of OPV, the GPEI developed the Polio Eradication & Endgame Strategic Plan 2013-2018.182,184,186 This strategic plan was endorsed by WHO and involves a global change from use of trivalent OPV (contains poliovirus types, 1, 2, and 3) to bivalent OPV (contains only poliovirus types 1 and 3) and introduction of at least one dose of IPV into routine immunization schedules in all countries.182,184,186

Primary Immunization

Infants and Children

ACIP, AAP, and other experts recommend that all infants and children receive primary immunization against poliomyelitis,1,9,105,199 usually initiated at 2 months of age.1,9,105,154,199 ACIP, AAP, and other experts also recommend catch-up vaccination for all children and adolescents 17 years of age or younger who are unvaccinated or incompletely vaccinated against poliomyelitis.105,199

Primary immunization against poliomyelitis can be integrated with age-appropriate primary immunization against diphtheria, tetanus, pertussis, hepatitis A, hepatitis B, Haemophilus influenzae type b (Hib), human papillomavirus (HPV), influenza, pneumococcal disease, meningococcal disease, measles, mumps, rubella, rotavirus, and varicella.9,68,105,134,199 (See Drug Interactions: Vaccines.)

Combination Vaccines Containing IPV and Other Antigens

IPV is commercially available in fixed-combination vaccines containing diphtheria, tetanus, pertussis, and poliovirus antigens (DTaP-IPV; Kinrix^®, Quadracel^®);221,223 a fixed-combination vaccine containing diphtheria, tetanus, pertussis, hepatitis B, and poliovirus antigens (DTaP-HepB-IPV; Pediarix^®);106 and a combination vaccine containing diphtheria, tetanus, pertussis, poliovirus, and Haemophilus influenza type b (Hib) antigens (DTaP-IPV/Hib; Pentacel^®).224

When indicated based on the age and vaccination status of the child and when there are no contraindications to any of the individual components, combination vaccines containing IPV and other antigens can be used instead of separate injections.105,106,134,199,223,224 ACIP, AAP, and other experts state that a combination vaccine generally is preferred over separate injections of the equivalent component vaccines;105,134,199 considerations include provider assessment (e.g., number of injections, vaccine availability, likelihood of improved coverage, likelihood of patient return, storage requirements, cost), patient preference, and potential for adverse effects.134

When there are no contraindications to any of the individual components, the commercially available fixed-combination vaccine containing diphtheria, tetanus, pertussis, and poliovirus antigens (DTaP-IPV; Kinrix^®) can be used in children 4 through 6 years of age to provide the fifth dose of the DTaP vaccination series and the fourth dose of the IPV vaccination series in those receiving primary immunization with Infanrix^® (DTaP) and/or Pediarix (DTaP-HepB-IPV).223 Alternatively, the commercially available fixed-combination vaccine containing diphtheria, tetanus, pertussis, and poliovirus antigens (DTaP-IPV; Quadracel^®) can be used in children 4 through 6 years of age to provide the fifth dose of the DTaP vaccination series and the fourth or fifth dose of the IPV vaccination series in those receiving primary immunization with Daptacel^® (DTaP) and/or Pentacel^® (DTaP-IPV/Hib).221,222

The commercially available fixed-combination vaccine containing diphtheria, tetanus, pertussis, hepatitis B, and poliovirus antigens (DTaP-HepB-IPV; Pediarix^®) can be used for a 3-dose immunization series in infants and children 6 weeks through 6 years of age when there are no contraindications to any of the individual components.106 ACIP states that this fixed-combination vaccine also may be used to complete the hepatitis B vaccine series in infants 6 months through 6 years of age born to HBsAg-positive women†.208 Pediarix^® should not be used for the initial dose of hepatitis B vaccine that is indicated in neonates.105,106 For prevention of poliomyelitis in infants and children 6 weeks through 6 years of age, Pediarix^® may be used for the initial 3 doses in the IPV series or may be used to complete the first 3 doses of the IPV series in those who have received 1 or 2 doses of another IPV vaccine.106

When doses of DTaP, 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, a kit (DTaP-IPV/Hib; Pentacel^®) containing a fixed-combination DTaP-IPV vaccine and Hib vaccine (ActHIB^®) can be used as a 4-dose vaccination series.173,224 Hib vaccine (ActHIB^®) in the kit is reconstituted with the fixed-combination DTaP-IPV in the kit to provide a combination vaccine containing diphtheria, tetanus, pertussis, poliovirus, and Hib antigens.224 (See Dosage and Administration: Reconstitution and Administration.) For prevention of poliomyelitis, children who receive the 4-dose series of Pentacel^® at 2, 4, 6, and 15 through 18 months of age should receive a dose of IPV vaccine at 4 through 6 years of age.224 Although Pentacel^® may be used in infants and children 6 weeks through 4 years of age who previously received 1 or more doses of another IPV vaccine,224,173 data are not available on safety and immunogenicity in such infants and children.224

Internationally Adopted Children and Other Immigrants

The number of children adopted from outside the US has increased substantially in recent years and the immune status of such children may be difficult to determine based on country of origin and medical records.134 Children adopted from other countries whose immune status is uncertain should be vaccinated according to the US Recommended Childhood and Adolescent 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 the administration schedule was similar to that recommended in the US childhood and adolescent 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 vaccines administered, intervals between doses, and child'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, most 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 Regarding vaccination with IPV, ACIP states that the simplest approach is to revaccinate internationally adopted children younger than 18 years of age with IPV according to the recommended US immunization schedule since adverse effects are rare with IPV.134 Although children may have been appropriately vaccinated with 3 doses of OPV in economically developing countries, they may have suboptimal seroconversion, including to type 3 poliovirus.134 If available, serologic tests for specific antibody to poliovirus types 1, 2, and 3 can be performed;134 those with protective titers against all 3 types do not need repeat doses, but should complete the age-appropriate IPV vaccination schedule.134

Adults

ACIP, AAP, and other experts state that routine immunization against poliomyelitis in previously unvaccinated immunocompetent adults 18 years of age or older is not considered necessary in the US since most adults already are immune and have a small risk of exposure to poliovirus.1,9,105,200 However, ACIP and other experts recommend that unvaccinated adults who are at an increased risk of exposure to either vaccine or wild-type poliovirus (e.g., travelers to countries where poliomyelitis is epidemic or endemic, certain health-care and laboratory personnel) receive primary immunization against poliomyelitis.1,9,105

Individuals with Altered Immunocompetence and their Household Contacts

ACIP and AAP state that inactivated vaccines, including IPV, do not represent a danger to immunocompromised individuals and generally should be administered as recommended for healthy individuals.105,134,151 However, the possibility that IPV may be less immunogenic in individuals with altered immunocompetence than in immunocompetent individuals should be considered.1,105,106,134,224 Although IPV is safe in individuals with altered immunocompetence and stimulation of some level of protection is possible, a protective immune response cannot be assured.1,105,134,151 (See Pharmacology: Response to IPV.)

HIV-infected Individuals

ACIP, AAP, CDC, and other experts state that recommendations regarding use of inactivated vaccines in HIV-infected adults, adolescents, and children are the same as those for individuals who are not infected with HIV.105,134,151,155,156 The possibility that inactivated vaccines, including IPV, may be less immunogenic in immunocompromised individuals should be considered.105,134

Hematopoietic Stem Cell Transplant Recipients

Although hematopoietic stem cell transplant (HSCT) recipients, including bone marrow transplant (BMT) recipients, may acquire the immunity of the donor, there is evidence that some individuals who previously were immune to certain infectious diseases (e.g., measles, mumps, rubella, tetanus, poliomyelitis) as the result of natural infection or immunization have diminished or absent levels of specific serum antibodies to these infectious agents within the first few years after autologous or allogeneic BMT.60,61,62,63,105,134 Decreased serum antibody titers to poliovirus types 1, 2, and/or 3 have been demonstrated in long-term survivors of allogeneic61,62,63 and autologous60,62 BMT who were previously immune; this effect has occurred in both children and adults.60,61,62,63

Because there is evidence that antibody titers to vaccine-preventable diseases decrease 1-4 years after autologous or allogeneic hematopoietic stem cell transplants, ACIP recommends that these patients be routinely revaccinated after hematopoietic stem cell transplant, regardless of the source of the transplant.134 These experts state that revaccination with inactivated vaccines (e.g., IPV) should generally be initiated 6 months after the procedure.134

Health-care and Laboratory Personnel

ACIP and the Hospital Infection Control Practices Advisory Committee of the US Public Health Service (HICPAC) state that primary immunization with IPV is recommended for previously unvaccinated health-care personnel who are at greater risk for exposure to polioviruses than the general population.235 This includes laboratory workers who handle specimens that might contain polioviruses and health-care personnel who have close contact with patients who may be excreting wild-type poliovirus, including those who travel to work in areas where polioviruses are circulating.235

Unvaccinated health-care and laboratory personnel at increased risk of exposure to polioviruses should receive primary immunization with a complete 3-dose series of IPV.235 Those who previously received routine immunization against poliomyelitis in childhood should receive a single supplemental (booster) dose of IPV if they remain at increased risk for exposure.235 Available data to date do not indicate a need for more than a single lifetime booster dose of IPV in adults.235

Travelers

Travelers to countries where poliomyelitis is epidemic or endemic are considered at risk of exposure to polioviruses and should be fully immunized.1,105,115,149,185 Although countries in the Western hemisphere, the Western Pacific Region (which encompasses China), the European region, and the South-East Asia region are considered free of wild-type poliovirus circulation,115,169 wild-type poliovirus continues to circulate in Afghanistan, Nigeria, and Pakistan.115,159,169,182,183

CDC states that all travelers to countries or areas with evidence of wild-type poliovirus circulation within the past 12 months (i.e., ongoing endemic circulation, polio outbreak, environmental evidence of wild-type poliovirus circulation based on sewage sampling) who are unvaccinated or incompletely vaccinated against poliovirus or whose immunization status is unknown should receive primary immunization with a 3-dose series of IPV prior to travel.115,185,187 This includes individuals working in health-care settings, refugee camps, or other humanitarian aid settings.115

If there is insufficient time to complete the full primary series of IPV before travel, 2 doses of IPV should be given at least 4 weeks apart.105,115 If protection is needed in less than 4 weeks, a single dose of IPV should be administered before travel.105,115 In any such case, the remaining doses of the series should be administered at the recommended intervals if the individual remains at increased risk of exposure to wild-type poliovirus.115

Because data regarding the duration of immunity following primary immunization against polioviruses are lacking,115 CDC also recommends that adults who will be traveling to areas that have had evidence of wild-type poliovirus circulation within the past 12 months and who received a routine series of IPV or OPV or a combination of IPV and OPV in childhood should receive a single supplemental (booster) dose of IPV before departure.115,185 Available data to date do not indicate a need for more than a single lifetime booster dose of IPV in adults.115

US residents who are planning long-term travel (for longer than 4 weeks) to countries where poliovirus transmission is occurring (e.g., Afghanistan, Pakistan) may be required to show proof that they received a dose of poliovirus vaccine between 4 weeks and 12 months before the date of departure from that country.115,185,187 Documentation of vaccination against poliomyelitis on an International Certificate of Vaccination or Prophylaxis (ICVP) may be required.115,185,187 If necessary, CDC states that US travelers staying for longer than 12 months in such areas may receive available poliovirus vaccine (IPV or OPV) while in the infected country to meet departure requirements.185,187

The CDC Travelers' Health website ([Web]) should be consulted for specific information regarding countries or areas where wild-type poliovirus is circulating and the most current information regarding vaccination requirements for travelers.115

Outbreak Control

National surveillance for poliomyelitis and investigation of suspected cases is conducted by CDC in collaboration with local and state health departments.166 A suspected case of poliomyelitis or nonparalytic poliovirus infection, regardless of whether wild-type or vaccine-derived poliovirus is involved, should be considered a public health emergency and requires immediate epidemiologic investigation.105 If a suspected case occurs, the CDC Emergency Operation Center at 770-488-7100 should be consulted regarding collection of appropriate clinical specimens for virus isolation and serology, procedures to rule out or confirm poliomyelitis, and evaluation of the likelihood that the disease may be caused by wild-type poliovirus.166

Dosage and Administration ⬆ ⬇

[Section Outline]

Administration
Dosage

Administration

Poliovirus vaccine inactivated (IPV; IPOL^®) is administered by IM or subcutaneous injection.1 IPV should not be administered IV.1

Fixed-combination vaccines containing IPV and diphtheria, tetanus, and pertussis antigens (DTaP-IPV; Kinrix^®, Quadracel^®),221,223 the fixed-combination vaccine containing IPV and diphtheria, tetanus, pertussis, and hepatitis B antigens (DTaP-HepB-IPV; Pediarix^®),106 and the vaccine containing IPV and diphtheria, tetanus, pertussis, and Haemophilus influenza type b (Hib) antigens (DTaP-IPV/Hib; Pentacel^®)224 are administered by IM injection. These combination vaccines should not be administered subcutaneously, intradermally, or IV.106,221,223,224

Syncope (vasovagal or vasodepressor reaction; fainting) may occur following vaccination;106,134,223 such reactions may be accompanied by transient neurologic signs (e.g., visual disturbance, paresthesia, tonic-clonic limb movements).106,223 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.106,223 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

When multiple vaccines are administered during a single health-care visit, each vaccine should be given with a different syringe and at a different injection site.134 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

IPV (IPOL®)

IPV is administered by IM or subcutaneous injection.1

Prior to administration, IPV should be inspected visually for particulate matter and discoloration.1 The vaccine should be shaken well immediately prior to administration and should appear as a clear and colorless suspension.1

IPV should not be mixed with any other vaccine or solution.1

IM Injection

Depending on patient age, IM injections of IPV should be made into the anterolateral muscles of the thigh or deltoid muscle of the arm.1,134 In infants and children 6 weeks though 2 years of age, IM injections should preferably be made into the anterolateral thigh;1,134 alternatively, the deltoid muscle can be used in those 1 through 2 years of age if muscle mass is adequate.134 In adults, adolescents, and children 3 years of age or older, IM injections should preferably be given in the deltoid muscle.1,73,77,134

IPV should not be injected into the gluteal area or any area where there may be a major nerve trunk.1,134 If the gluteal muscle is chosen for infants younger than 12 months of age because of special circumstances (e.g., physical obstruction of other sites), it is essential that the clinician identify anatomic landmarks prior to injection.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.134,171,172

Subcutaneous Injection

Subcutaneous injections of IPV should be made into the upper-outer triceps area or anterolateral thigh.134 For infants younger than 1 year of age, subcutaneous injections should preferably be administered into the anterolateral thigh; subcutaneous injections can also be administered into the upper-outer triceps of an infant, if necessary.134 In adults, adolescents, and children, the upper-outer triceps area is preferred.134

To ensure appropriate delivery, subcutaneous injections should be made at a 45° angle using a 5/8-inch, 23- to 25-gauge needle.134

Combination Vaccines Containing IPV and Other Antigens

DTaP-IPV (Kinrix^®, Quadracel^®),221,223 DTaP-HepB-IPV (Pediarix^®),106 and DTaP-IPV/Hib (Pentacel^®)224 are administered by IM injection.

The vaccine should be shaken well prior to administration to provide a uniform, white, cloudy suspension and should be discarded if it contains particulates, appears discolored, or cannot be resuspended with thorough agitation.106,221,223,224

Kinrix^®, Quadracel^®, Pediarix^®, or reconstituted Pentacel^® should not be mixed with any other vaccine or solution.106,221,223

IM Injection

Depending on patient age, IM injections should be made into he anterolateral muscles of the thigh or deltoid muscle of the arm.134,106,221,223,224 In infants and children 6 weeks through 2 years of age, IM injections should preferably be made into the anterolateral thigh;106,134,224 alternatively, the deltoid muscle can be used in those 1 through 2 years of age if muscle mass is adequate.134 In children 3 years of age or older, IM injections should preferably be given in the deltoid muscle.106,134,221,223

IM injections should not be injected into the gluteal area or any area where there may be a major nerve trunk.1,134 If the gluteal muscle is chosen for infants younger than 12 months of age because of special circumstances (e.g., physical obstruction of other sites), it is essential that the clinician identify anatomic landmarks prior to injection.134

Reconstitution (Pentacel®)

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

Prior to administration, a vial of lyophilized ActHIB^® vaccine from the kit should be reconstituted by adding the entire contents of a vial of the DTaP-IPV vaccine from the kit according to the manufacturer's instructions to provide a combined preparation containing diphtheria, tetanus, pertussis, poliovirus, and Hib antigens.224 The reconstituted vaccine should be shaken thoroughly until a cloudy, uniform suspension is obtained.224

Pentacel^® should be administered immediately after reconstitution.224

Dosage

The poliovirus vaccine dosing schedule varies according to the individual's age and immunization status.1,9,105,199

Medically stable preterm and low-birthweight infants generally should be vaccinated at the usual chronologic age using usual dosage.105,134 (See Cautions: Pediatric Precautions.)

Interruption of the recommended immunization schedule, regardless of the length of time between doses, does not interfere with the final immunity achieved and does not necessitate additional doses or starting the series over.1,9,105,134,199

IPV (IPOL®)

IPV is administered in 0.5-mL doses.1

Each 0.5-mL dose of IPV commercially available for use in the US contains 40 D antigen units (DU) of poliovirus type 1 (Mahoney strain), 8 DU of poliovirus type 2 (MEF-1 strain), and 32 DU of poliovirus type 3 (Saukett strain).1

IPV (IPOL^®) is used in adults, adolescents, and infants and children 6 weeks of age or older.1

The complete IPV vaccine series must be administered to ensure optimal protection against poliovirus.134

Infants and Children 6 Weeks Through 6 Years of Age

For primary immunization against poliomyelitis in infants and children 6 weeks through 6 years of age, a 4-dose IPV regimen is recommended.1,9,105,179,199

The US Public Health Service Advisory Committee on Immunization Practices (ACIP), American Academy of Pediatrics (AAP), and the manufacturer recommend that IPV doses be administered at 2 months, 4 months, 6 through 18 months, and 4 through 6 years of age.1,9,105,179,199 If a dose was not given at 4-6 years of age, a booster dose should be given as soon as feasible.179

The initial IPV dose may be given as early as 6 weeks of age,1,105,199 but only if considered necessary because of imminent exposure to circulating poliovirus (e.g., during an outbreak, travel to a region where poliovirus is endemic) since lower seroconversion rates may occur.179

For catch-up vaccination in previously unvaccinated children 4 months through 6 years of age who did not receive IPV at the usually recommended time in early infancy, a 4-dose regimen is recommended.105,199 However, a fourth dose is not necessary if the third dose was given at 4 years of age or older and at least 6 months after the previous dose.105,199

The minimum interval between the first and second IPV dose and between the second and third IPV dose is 4 weeks; the minimum interval between the third and fourth IPV dose is 6 months.105,179,199 In infants 6 months of age or younger, the minimum intervals should be used only if considered necessary because of imminent exposure to circulating poliovirus (e.g., during an outbreak, travel to a region when poliovirus in endemic)179,199 since lower seroconversion rates may occur.179

Children and Adolescents 7 Through 17 Years of Age

For primary or catch-up immunization against poliomyelitis in children and adolescents 7 through 17 years of age, a 4-dose series of IPV is recommended.1,9,105,199

To complete the vaccination series in children 7 through 17 years of age who are incompletely vaccinated, a fourth dose is not necessary in those who received the third dose at 4 years of age or older and at least 6 months after the previous dose.199

Regardless of current age, a fourth dose is necessary in those who received a vaccination series that included both IPV and OPV.199

The minimum interval between the first and second IPV dose and between the second and third IPV dose is 4 weeks; the minimum interval between the third and fourth IPV dose is 6 months.105,179,199

Adults at Increased Risk of Exposure to Poliovirus

Adults at increased risk of exposure to poliovirus (e.g., travelers to countries where poliomyelitis is epidemic or endemic, certain health-care and laboratory personnel) should receive primary immunization with 3 doses of IPV.1,9,105,166 The recommended schedule for adults is 2 doses given 4-8 weeks apart and a third dose given 6-12 months after the second dose.1,9,105,166

Adults who have not received the complete primary series of IPV and who are at increased risk of exposure to poliovirus, including those who have received at least one dose of OPV, fewer than 3 doses of any IPV vaccine, or fewer than 3 doses of a combination of OPV and IPV, should receive the remaining doses of IPV at the recommended intervals.1,9,105,166

When an accelerated immunization schedule is required to provide protection against poliomyelitis (e.g., for international travel to areas where poliomyelitis is endemic or epidemic), adults should receive 3 doses of IPV given at least 4 weeks apart.1,9,105,166 If only 1 or 2 months are available before protection is needed, 2 doses of IPV should be given at least 4 weeks apart.1,105,166 If less than 1 month is available before protection is needed, a single dose of IPV should be administered.1,9,105,166

Adults who previously received a complete 3-dose primary series of IPV or OPV or a combination of IPV and OPV in childhood and who are at an increased risk of exposure to poliovirus should receive a supplemental (booster) dose of IPV.1,9,105,115,166,235 Available data to date do not indicate a need for more than a single lifetime booster dose of IPV in adults.9,105,115,166,235

Combination Vaccines Containing IPV and Other Antigens

DTaP-IPV (Kinrix®, Quadracel®)

Fixed-combination vaccines containing diphtheria, tetanus, pertussis, and poliovirus antigens (DTaP-IPV; Kinrix^®, Quadracel^®) are used only in children 4 through 6 years of age.221,223

Kinrix^® and Quadracel^® are administered in 0.5-mL doses.221,223

Kinrix^® may be used for the fifth dose of the diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DTaP) vaccination series and the fourth dose of the IPV vaccination series in children 4 through 6 years of age who have been receiving primary immunization with Infanrix^® (DTaP) and/or Pediarix^® (DTaP-HepB-IPV).223

Quadracel^® may be used to provide the fifth dose in the DTaP vaccination series and the fourth or fifth dose of the IPV vaccination series in children 4 through 6 years of age who have been receiving primary immunization with Pentacel^® (DTaP-IPV/Hib) and/or Daptacel^® (DTaP).221,222

DTaP-HepB-IPV (Pediarix®)

The fixed-combination vaccine containing diphtheria, tetanus, pertussis, hepatitis B, and poliovirus antigens (DTaP-HepB-IPV; Pediarix^®) is used only in infants and children 6 weeks through 6 years of age.106

The manufacturer states that Pediarix^® is indicated only in infants born to HBsAg- negative women.106 ACIP states that Pediarix^® also may be used in infants born to HBsAg- positive women†.208

Pediarix^® is administered in 0.5-mL doses.106

In previously unvaccinated infants and children 6 weeks through 6 years of age, Pediarix^® is given in a series of 3 doses at 2, 4, and 6 months of age (at 6- to 8-week intervals, preferably 8-week intervals).106 The initial dose usually is given at 2 months of age, but may be given as early as 6 weeks of age.106

To complete vaccination against poliovirus in children who received a 3-dose series of Pediarix^®, a dose of monovalent IPV (IPOL^®) should be administered at 4 through 6 years of age.106,199

To complete the recommended primary and booster regimen against diphtheria, tetanus, and pertussis in children who received a 3-dose series of Pediarix^®, a fourth or fifth dose of DTaP should be administered if indicated.106 The manufacturer recommends that Infanrix^® be used for the fourth dose of DTaP at 15-18 months of age and either the Infanrix^® DTaP vaccine or DTaP-IPV (Kinrix^®) be used as the fifth dose of DTaP at 4 through 6 years of age since these vaccines contain the same pertussis antigens as Pediarix^®.106,223

In infants and children 6 weeks through 6 years of age who previously received 1 or 2 doses of IPV from a different manufacturer, Pediarix^® can be used to complete the first 3 doses of the IPV series if doses of DTaP and hepatitis B vaccine also are indicated and there are no contraindications to any of the individual components.106

In infants and children 6 weeks through 6 years of age who previously received 1 or 2 doses of the Infanrix^® DTaP vaccine,106 Pediarix^® may be used to complete the first 3 doses of the DTaP vaccine series if doses of IPV and hepatitis B vaccine also are indicated and there are no contraindications to any of the individual components.106 Data are not available regarding the safety and efficacy of Pediarix^® used following 1 or more doses of DTaP vaccines from other manufacturers.106

In infants and children 6 weeks through 6 years of age who previously received 1 or 2 doses of another hepatitis B vaccine (monovalent or combination vaccine), Pediarix^® may be used to complete the 3-dose hepatitis B vaccine series if doses of IPV and DTaP also are indicated and there are no contraindications to any of the individual components.106 Pediarix^® should not be used for the initial dose of hepatitis B vaccine that is indicated in neonates.106 Although a 3-dose series of Pediarix^® may be used in infants who received a dose of hepatitis B vaccine at or shortly after birth,106 the manufacturer states that data are limited regarding the safety of the vaccine in such infants.106 Data are not available to support the use of a 3-dose series of Pediarix^® in infants who previously received more than 1 dose of hepatitis B vaccine.106

DTaP-IPV/Hib (Pentacel®)

The combination vaccine containing diphtheria, tetanus, pertussis, poliovirus, and Hib antigens (DTaP-HepB-IPV; Pentacel^®) is used only in infants and children 6 weeks through 4 years of age.224

Pentacel^® is administered in 0.5-mL doses.224

Pentacel^® may be used when immunization against diphtheria, tetanus, pertussis, poliovirus, and Hib is indicated in infants and children 6 weeks through 4 years of age.173,224

In previously unvaccinated children 6 weeks through 4 years of age, Pentacel^® is given in a series of 4 doses.224 The doses should 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

To complete vaccination against poliovirus in children who received the 4-dose regimen of Pentacel^® 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.179,224 This results in a 5-dose series of IPV, which is considered acceptable by ACIP.179 To ensure an optimum booster response, the minimum interval between the fourth dose of Pentacel^® and fifth IPV dose should be 6 months.179

To complete the recommended primary and booster regimen against diphtheria, tetanus, and pertussis in children who received the 4-dose regimen of Pentacel^® at 2, 4, 6, and 15 through 18 months of age, a fifth dose of DTaP (Daptacel^®) should be given at 4 through 6 years of age.224 Pentacel^® should not be used for the booster dose of DTaP indicated at 4 through 6 years of a however, if a dose of Pentacel^® is inadvertently given to a child 5 years of age or older, ACIP states the dose may be counted as a valid dose.173

In children 6 weeks through 4 years of age who previously received 1 or more doses of IPV, Pentacel^® can be used to complete the IPV series when doses of IPV, DTaP, and Hib vaccine also are indicated and there are no contraindications to any of the individual components.173,224

In children 6 weeks through 4 years of age who previously received 1 or more doses of DTaP (Daptacel^®), Pentacel^® can be used to complete the DTaP vaccination series when doses of IPV and Hib vaccine also are indicated and there are no contraindications to any of the individual components.173,224

In children 6 weeks through 4 years of age who previously received 1 or more doses of Hib vaccine, Pentacel^® can be used to complete the Hib series when doses of IPV and DTaP vaccine also are indicated and there are no contraindications to any of the individual components.173,224 If Hib vaccines from different manufacturers are used to complete the series, a total of 4 doses of vaccine containing Hib antigen (3 primary and a booster dose) are necessary.224

Cautions ⬆ ⬇

[Section Outline]

IPV
DTaP-IPV (Kinrix®)
DTaP-IPV (Quadracel®)
DTaP-HepB-IPV (Pediarix®)
DTaP-IPV/Hib (Pentacel®)
Precautions and Contraindications
Pediatric Precautions
Geriatric Precautions
Mutagenicity and Carcinogenicity
Pregnancy, Fertility, and Lactation

IPV

IPV generally is well tolerated.9,15,20,21,27,43,151,153 Information on safety and efficacy of IPV has been obtained from clinical studies using various inactivated poliovirus vaccines (i.e., those propagated in human diploid cells, primary monkey kidney cells, or VERO cells) with differing potencies.1,83 Unlike poliovirus vaccine live oral (OPV; no longer commercially available in the US), the risk of vaccine-associated paralytic poliomyelitis in either immunocompetent individuals or individuals with altered immunocompetence is essentially nonexistent with IPV since this virus is inactivated during manufacture of this vaccine.20,21,27,42,83,108,150,151 (See Cautions: Systemic Effects.)

Local Effects

Local reactions at the injections site that are mild and transient may occur following administration of IPV.1 In a study in children who received IM doses of the commercially available IPV vaccine at 2, 4, and 18 months of age, erythema, swelling, or tenderness occurred at the injection site in 0.5-1.4, 2.7-11.4, or 13.5-29.4% of patients, respectively, within 6 hours of a dose.1 In another study using a similar IPV formulation (propagated in primary monkey kidney cells rather than VERO cells), transient local effects such as erythema, induration, and pain occurred at the injection site within 48 hours in 1-13% of vaccine recipients;1,28 however, the frequency and severity of these effects were comparable to those observed with placebo.28

Systemic Effects

In a study in children who received IM doses of the IPV formulation available for use in the US concurrently with a dose of diphtheria and tetanus toxoids and whole-cell pertussis vaccine adsorbed (DTP; no longer available in the US) or a dose of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DTaP) at a separate site at 2, 4, and 18 months of age, fever (exceeding 38°C), irritability, tiredness, anorexia, or vomiting occurred in 0.5-4.2, 6.7-64.5, 4-60.7, 1.3-16.6, or 1.3-2.8%, respectively, occurred in children within 48 hours after vaccination; persistent crying occurred in up to 1.4% of children within 72 hours after vaccination.1 In another study evaluating use of a similar IPV formulation (propagated in primary monkey kidney cells rather than VERO cells) administered concurrently with DTP at a different site, fever (39°C or greater) occurred in up to 38% of vaccine recipients and irritability, sleepiness, fussiness, and crying also occurred.1,28 Although the incidence of fever and other systemic effects in both studies was similar to that reported when DTP or DTaP was administered alone (without IPV), it was not possible to attribute adverse effects to a particular vaccine.1,28

Although a causal relationship has not been established between administration of IPV and Guillain-Barré syndrome (GBS), GBS was temporally related to administration of an IPV formulation that differs from the formulation commercially available for use in the US.1

Although a causal relationship was not established, deaths have been reported in temporal association with administration of IPV to infants.1

In 1955, paralytic poliomyelitis occurred in a cluster of IPV vaccine recipients and their contacts and apparently resulted from a production problem that caused incomplete inactivation of the polioviruses contained in one manufacturer's IPV formulation.7,16,20,21,27,42,43,44,96,108,110 No cases of vaccine-associated paralysis have been reported with subsequent formulations or with available formulation of IPV.7,16,20,21,27,42,43,44,96,138,139 A few batches of IPV produced between 1954 and 1961 were contaminated with a simian virus known to be oncogenic in hamsters (SV-40); however, improved manufacturing procedures, including testing for the presence of the virus, have ensured that SV-40 has not been present in any IPV formulation produced in the US since 1961.7,43,44,135

DTaP-IPV (Kinrix®)

In a US clinical study, children 4-6 years of age were randomized to receive either the fixed-combination vaccine containing IPV and diphtheria, tetanus, and pertussis antigens (DTaP-IPV; Kinrix^®) or control vaccines (DTaP [Infanrix^®] and IPV administered concomitantly at different sites) for the fifth DTaP dose and fourth IPV dose in the primary vaccination series.223 Both groups also received measles, mumps, and rubella virus vaccine live (MMR) concurrently at a different site.223 Adverse effects occurring within 4 days of vaccination were solicited from parents and included local injection site reactions (pain, redness, increase in arm circumference, swelling) and systemic effects (drowsiness, fever, loss of appetite).223 Those who received Kinrix^® had a slightly higher incidence of grade 3 pain (preventing normal daily activities) and fever exceeding 38°C (1.6 and 6.5%, respectively) compared with those who received control vaccines (0.6 and 4.4%, respectively),223 The incidence of local swelling and increase in arm circumference (swelling involving at least 50% of the injected upper arm length and associated with an increase in mid-upper arm circumference greater than 30 mm) was similar in both groups.223

DTaP-IPV (Quadracel®)

In a clinical study, children 4-6 years of age were randomized to receive either the fixed-combination vaccine containing IPV and DTaP (DTaP-IPV; Quadracel^®) or DTaP (Daptacel^®) and IPV administered concomitantly at different sites.221 Both groups also received MMR and varicella virus vaccine live concurrently at 2 other separate sites.221 Local and systemic adverse effects occurring within 7 days of vaccination were solicited.221 The incidence of pain, change in limb circumference, erythema, and swelling in those who received Quadracel^® was 77, 68, 59, and 40%, respectively, and was similar to that reported when DTaP and IPV were administered separately (77, 65, 53, and 36%, respectively).221 The incidence of myalgia, malaise, headache, and fever in those who received Quadracel^® was 54, 35, 16, and 6%, respectively, and was similar to that reported when DTaP and IPV were administered separately (53, 33, 17, and 7%, respectively).221

DTaP-HepB-IPV (Pediarix®)

Adverse effects reported in at least 25% of patients following any dose of the fixed-combination vaccine containing IPV and diphtheria, tetanus, pertussis, and hepatitis B antigens (DTaP-HepB-IPV; Pediarix®) are local reactions at the injection site (pain, erythema, swelling), loss of appetite, drowsiness, fever, and irritability/fussiness.106

In a US clinical study in infants who received a 3-dose primary series (at 2, 4, and 6 months of age) of either the fixed-combination vaccine (DTaP-HepB-IPV; Pediarix®) or control vaccines (IPV, DTaP [Infanrix^®], and HepB [Engerix-B^®] administered concomitantly at separate sites), adverse effects occurring within 4 days of vaccination were solicited from parents and included local injection site reactions (pain, redness, swelling) and systemic effects (fever, drowsiness, irritability/fussiness, loss of appetite).106 All infants also received Haemophilus influenzae type b (Hib) vaccine and pneumococcal 7-valent conjugate vaccine concomitantly at separate sites.106 There was a higher incidence of redness and swelling with the fixed-combination vaccine compared with administration of the individual components of the vaccine.106 There also was a higher incidence of fever (38°C or higher) after each of the 3 doses of the fixed-combination vaccine compared with when the vaccines were given separately.106 Fever was highest on the day of vaccination and the day following vaccination; almost all episodes of fever resolved within the 4-day period following vaccination.106

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 IPV and diphtheria, tetanus, pertussis, 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 concomitantly at separate 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) concomitantly at separate sites.224 The incidence of swelling or tenderness at the injection site in those who received DTaP-IPV/Hib (Pentacel®) was 5-9.7% or 39.2-56.1%, respectively, and was similar to that reported with DTaP vaccine alone (4-10.3% or 38.2-51.1%, respectively).224 The incidence of fever (38°C or higher) after the first, second, and third dose was 5.8, 10.9, and 16.3%, respectively, after the fixed-combination vaccine and 9.3, 16.1, and 15.8%, 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 47.3-59.3% or 68-76.9%, respectively after the fixed-combination vaccine compared with 47.9-58.5% or 67.1-75.8%, 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 IPV, 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.1 (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 IPV and should be provided with a copy of the appropriate Vaccine Information Statement (available at the CDC website [Web]).1,162,163 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.1 Clinicians or individuals can report any adverse reactions that occur following vaccination to VAERS at 800-822-7967 or [Web].1

IPV

IPV is contraindicated in individuals with a history of hypersensitivity to any ingredient in the vaccine, including phenoxyethanol, formaldehyde, neomycin, streptomycin, and polymyxin B.1 (See Allergy to Neomycin or Other Anti-infectives under Precautions and Contraindications: Sensitivity Reactions, in Cautions.) If anaphylaxis or anaphylactic shock occurs within 24 hours after administration of a dose of IPV, no further doses of the vaccine should be given.1

DTaP-IPV (Kinrix®)

The fixed-combination vaccine containing IPV and diphtheria, tetanus and pertussis antigens (DTaP-IPV; Kinrix^®) is contraindicated in those with a history of a severe allergic reaction (e.g., anaphylaxis) to any ingredient in the vaccine (including neomycin, polymyxin B) or following a previous dose of any vaccine containing diphtheria, tetanus, pertussis, or poliovirus antigens.223

Kinrix^® also is contraindicated (because of the pertussis antigen) in individuals who had encephalopathy (e.g., coma, decreased consciousness, prolonged seizures) within 7 days of a prior dose of a vaccine containing pertussis antigens that could not be attributed to another identifiable cause and in individuals with progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy.223

DTaP-IPV (Quadracel®)

The fixed-combination vaccine containing IPV and DTaP (DTaP-IPV; Quadracel^®) is contraindicated in those with a history of severe allergic reaction (e.g., anaphylaxis) to any ingredient in the vaccine or following a previous dose of any vaccine containing diphtheria, tetanus, pertussis, or poliovirus antigens.221

Quadracel^® also is contraindicated (because of the pertussis antigen) in individuals who had encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days of a previous dose of a vaccine containing pertussis antigens that could not be attributed to another identifiable cause and in individuals with progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy.221

DTaP-HepB-IPV (Pediarix®)

The fixed-combination vaccine containing IPV and diphtheria, tetanus, pertussis, and hepatitis B antigens (DTaP-HepB-IPV; Pediarix^®) is contraindicated in individuals with a history of hypersensitivity to any ingredient in the vaccine (e.g., yeast, neomycin, polymyxin B) or a history of serious allergic reaction (e.g., anaphylaxis) temporally associated with a previous dose of the vaccine or any vaccine component.106 The manufacturing process for the hepatitis B vaccine component of DTaP-HepB-IPV (Pediarix^®) involves baker's yeast ( Saccharomyces cerevisiae ) and the final product contains yeast protein (no more than 5%);106 therefore, the manufacturer states the vaccine is contraindicated in individuals hypersensitive to yeast.106

Pediarix also is contraindicated (because of the pertussis antigen) in individuals who had encephalopathy (e.g., coma, decreased consciousness, prolonged seizures) within 7 days of a previous dose of a vaccine containing pertussis antigens that could not be attributed to another identifiable cause and in individuals with progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy.106

DTaP-IPV/Hib (Pentacel®)

The combination vaccine containing IPV and diphtheria, tetanus, pertussis, and Hib antigens (DTaP-IPV/Hib; Pentacel^®) is contraindicated in individuals with a history of 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

Pentacel^® also is contraindicated (because of the pertussis antigen) 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

Sensitivity Reactions

Hypersensitivity reactions, including anaphylactic reactions and anaphylactic shock, have been reported during postmarketing experience following administration of IPV.1 Rash and urticaria also have been reported.1

All known precautions to prevent adverse reactions, including a review of the patient's history with respect to possible hypersensitivity to the vaccine or similar vaccines should be considered.1,106,223,224

Epinephrine and other appropriate agents should be available in case an immediate allergic reaction occurs following administration of IPV.1,106,221,223,224

Additional vaccine doses should not be administered to individuals who developed anaphylaxis or anaphylactic shock within 24 hours after a previous dose.1,106,223,224

Allergy to Neomycin or Other Anti-infectives

The possibility that allergic reactions to anti-infective agents used in the production of commercially available IPV (neomycin, polymyxin B, streptomycin) or combination vaccines containing IPV (neomycin, polymyxin B) could occur should be considered.1,9,106,151,223,224 Although purification procedures eliminate measurable amounts of these anti-infectives, trace amounts may be present in the vaccines.1,9,106,151,221,223,224

Neomycin allergy usually is characterized by a delayed-type (cell-mediated) hypersensitivity reaction, such as contact dermatitis, rather than an anaphylactic reaction.134 The US Public Health Service Advisory Committee on Immunization Practices (ACIP) states that vaccines containing trace amounts of neomycin should not be used in individuals with a history of anaphylactic reaction to neomycin, but use of such vaccines may be considered in those with a history of a delayed-type hypersensitivity reaction to neomycin if benefits of vaccination outweigh risks.134

Latex Sensitivity

Some components (i.e., tip cap, plunger) of the single-dose prefilled syringes of DTaP-IPV (Kinrix^®) or single-dose prefilled syringes of DTaP-HepB-IPV (Pediarix^®) contain dry natural latex;106,223 the vial stoppers are latex-free.106,223

Some individuals may be hypersensitive to natural latex protein and appropriate precautions should be taken if this preparation is administered to individuals with a history of latex sensitivity.134,223

ACIP states that vaccines supplied in vials or syringes containing dry natural rubber or natural rubber latex may be administered to individuals with latex allergies other than anaphylactic allergies (e.g., history of contact allergy to latex gloves), but should not be used in those with a history of severe (anaphylactic) allergy to latex, unless the benefits of vaccination outweigh the risk of a potential allergic reaction.134

Individuals with Altered Immunocompetence

Because IPV is an inactivated vaccine, it may be used when indicated in individuals with altered immunocompetence;1,105,134,155,156,224 however, the possibility that these individuals may not have an adequate antibody response to the vaccine should be considered.1,105,134 If possible, IPV should be administered prior to initiation of immunosuppressive therapy or should be deferred until immunosuppressive therapy is discontinued.134 (See Drug Interactions: Immunosuppressive Agents.)

Concomitant Illness

A history of clinical poliomyelitis (usually caused by only a single poliovirus type) or a history of incomplete immunization with OPV does not contraindicate use of IPV; therefore, the vaccine may be used to complete primary immunization in such individuals.1,134

The decision whether to administer or delay administration of IPV in an individual with a current or recent acute illness depends largely on the severity of symptoms and etiology of the illness.134,146,147,148 The manufacturer states that vaccination of individuals with any acute, febrile illness should be deferred until after recovery.1 ACIP, AAP, and other experts state that minor acute illness, such as mild upper respiratory infection (with or without fever) or mild diarrhea, does not preclude vaccination.9,105,134,146,147,148 However, vaccination of individuals with moderate or severe acute illness should be deferred until they have 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

Individuals with Bleeding Disorders

ACIP states that vaccines may be given IM to individuals who have bleeding disorders or are receiving anticoagulant therapy if a clinician familiar with the patient's bleeding risk determines that the preparation can be administered 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 If an IM vaccine is used in an individual with a bleeding disorder who is receiving antihemophilic factor or other similar therapy, the IM vaccine can be scheduled shortly after a scheduled dose of such therapy to minimize the risk of bleeding.134

The vaccine recipient and/or their family should be advised about the risk of hematoma from IM injections.134

Use of Combination Vaccines

When the fixed-combination vaccine containing diphtheria, tetanus, pertussis, and poliovirus antigens (DTaP-IPV; Kinrix^®, Quadracel^®),221,223 fixed-combination vaccine containing diphtheria, tetanus, pertussis, hepatitis B, and poliovirus antigens (DTaP-HepB-IPV; Pediarix^®),106 or combination vaccine containing diphtheria, tetanus, pertussis, poliovirus, and Hib antigens (DTaP-IPV/Hib; Pentacel^®)224 is used, the adverse effects, cautions, and precautions associated with each antigen should be considered.

For more complete information regarding the adverse effects, precautions, and contraindications associated with use of vaccines that contain diphtheria, tetanus, and pertussis 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 more complete information regarding the adverse effects, precautions, and contraindications associated with use of vaccines that contain hepatitis B antigens, see Cautions in Hepatitis B Vaccine 80:12.

For more complete information regarding the adverse effects, precautions, and contraindications associated with use of vaccines that contain Hib antigens, see Cautions in Haemophilus b Vaccine 80:12.

Limitations of Vaccine Efficacy

IPV and combination vaccines containing IPV may not protect all vaccine recipients against poliomyelitis.1,106,221

To ensure optimal protection, the complete IPV vaccination series must be administered.134

Administration of 2 doses of IPV results in seroconversion to poliovirus types 1, 2, and 3 in 95% of recipients; administration of 3 doses results in seroconversion in 99-100% of recipients.105

Improper Storage and Handling

Improper storage or handling of vaccines may reduce vaccine potency and can result 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 IPV (IPOL^®), DTaP-IPV (Kinrix^®, Quadracel^®), DTaP-HepB-IPV (Pediarix^®), or DTaP-IPV/Hib (Pentacel^®) that has been mishandled or has not been stored at the recommended temperature should not be administered.1,106,134 (See Chemistry and Stability: Stability.)

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

Safety and efficacy of IPV in children younger than 6 weeks of age have not been established.1

Safety and efficacy of DTaP-IPV (Kinrix^®, Quadracel^®) have not been established in children younger than 4 years of age or in children 7 years of age or older.221,223

Safety and efficacy of DTaP-HepB-IPV (Pediarix^®) have not been established in infants younger than 6 weeks of age or in children 7 years of age or older.106 Safety and efficacy of Pediarix^® in infants 6 weeks through 6 months of age were established on the basis of clinical studies; safety and efficacy in those 7 months through 6 years of age are supported by evidence in infants 6 weeks through 6 months of age.106

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

Because apnea has been reported following IM administration of vaccines in some infants born prematurely, decisions regarding use of IM vaccines in infants born prematurely should be based on consideration of the individual infant's medical status and potential benefits and possible risks of vaccination.106

Geriatric Precautions

DTaP-IPV (Kinrix^®, Quadracel^®), DTaP-HepB-IPV (Pediarix^®), and DTaP-IPV/Hib (Pentacel^®) are not indicated for use in adults, including geriatric adults.106,221,223,224

Mutagenicity and Carcinogenicity

In a study using doses equivalent to the usual human dosage, IPV did not induce micronuclei formation in a mouse micronucleus assay.81 Long-term animal studies to evaluate the mutagenic and carcinogenic potential of IPV or combination vaccines containing IPV have not been conducted.1,223

Pregnancy, Fertility, and Lactation

Pregnancy

Animal reproduction studies have not been performed to date with IPV.1 It is not known if the vaccine can cause fetal harm when administered to pregnant women.1 IPV should be administered during pregnancy only when clearly needed.1,9,105,134

Pregnant women generally do not need to be immunized against poliomyelitis unless they are at substantial risk of imminent exposure to infection (e.g., traveling to areas of high risk).9,105 If a pregnant woman is unvaccinated or incompletely vaccinated and requires immediate protection against poliovirus because of planned travel to a country or area where wild-type poliovirus is actively circulating, CDC states that IPV can be administered as recommended for other adults.115 (See Travelers under Uses: Primary Immunization.)

DTaP-IPV (Kinrix^®, Quadracel^®), DTaP-HepB-IPV (Pediarix^®), and DTaP-IPV/Hib (Pentacel^®) are not indicated for use in adults, including pregnant women.106,221,223,224

Fertility

It is not known if IPV can affect fertility.1

Lactation

It is not known whether antigens contained in IPV are distributed into milk.1 The manufacturer states that IPV should be used with caution in nursing women.1 Although specific data are not available, ACIP and AAP state that breast-feeding is not a contraindication to administration of inactivated vaccines since inactivated vaccines do not multiply within the body and such vaccines appear to pose no special problems for the mother or her nursing infant.9,105,134 CDC states that breast-feeding is not a contraindication for use of IPV in the infant or mother.115

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]) or specific immune 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 The US Public Health Service Advisory Committee on Immunization Practices (ACIP) states that inactivated vaccines such as poliovirus vaccine inactivated (IPV) may be given simultaneously with (using different syringes and different injection sites) or at any interval before or after immune globulin preparations.134

Immunosuppressive Agents

Individuals receiving immunosuppressive therapy (e.g., corticotropin, corticosteroids, alkylating agents, antimetabolites, radiation therapy) may have a diminished immunologic response to vaccines, including IPV,1,105,221,223,224 and administration of the vaccine generally should be deferred until immunosuppressive therapy is discontinued.134 Individuals who are immunized within 2 weeks prior to or while receiving chemotherapy or radiation therapy should be considered unimmunized and should be revaccinated at least 3 months after such therapy is discontinued if immune competence has been restored.134

Vaccines

Although specific studies may not be available evaluating concurrent administration of IPV with each antigen, simultaneous 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.1,105,134

Immunization with IPV 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, rotavirus, meningococcal disease, pneumococcal disease, and varicella.105,134,199 However, unless combination vaccines appropriate for the age and vaccination status of the recipient are used, each parenteral vaccine should be administered using a different syringe and different injection site.134

Inactivated Vaccines and Toxoids

IPV may be administered concomitantly with or at any interval before or after other inactivated vaccines or toxoids routinely used in children or adults.134

Diphtheria and Tetanus Toxoids and Pertussis Vaccines

IPV may be administered concomitantly with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DTaP) or with diphtheria and tetanus toxoids adsorbed at separate sites using different syringes.1,14,68,69,134 Alternatively, IPV is commercially available in fixed combination with DTaP (DTaP-IPV; Kinrix^®, Quadracel^®),221,223 in fixed combination with DTaP and hepatitis B vaccine (DTaP-HepB-IPV; Pediarix^®),106 and in combination with DTaP and Hib vaccine (DTaP-IPV/Hib; Pentacel^®).224 Depending on the age and vaccination status of the child, these combination vaccines can be used instead of separate injections of DTaP and IPV when indicated and if there are no contraindications to any of the individual components.106,134,221,223,224 (See Combination Vaccines Containing IPV and Other Antigens under Primary Immunization: Infants and Children, in Uses.)

Extemporaneous vaccine combinations of DTaP and IPV should not be prepared by admixing IPV and DTaP in the same syringe.138,139

Haemophilus b Vaccines

IPV may be administered concomitantly with Hib vaccines using separate syringes and different injection sites.1,9,68,75,76,134 Alternatively, IPV is commercially available in combination with DTaP 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 IPV and Hib vaccine when indicated and if there are no contraindications to any of the individual components.224 (See Combination Vaccines Containing IPV and Other Antigens under Primary Immunization: Infants and Children, in Uses.)

Studies have evaluated concomitant administration of IPV with Hib polysaccharide conjugate (tetanus toxoid conjugate) vaccine (PRP-T; ActHIB^®).68,74,75 In a study in infants who received a fixed combination of IPV and DTP with PRP-T at 2, 4, and 6 months of age administered concurrently at separate sites using separate syringes or mixed in the same syringe, systemic reactions were similar in both groups and local reactions occurred in 15-27 and 11-24% of patients, respectively.74 There was no difference in antibody response to IPV or diphtheria toxoid adsorbed between the groups; however, antibodies elicited by PRP-T, tetanus toxoid adsorbed, and pertussis antigens were lower in infants who received the vaccines in the same syringe at the same site compared with those who received the fixed combination of DTP and IPV at one site and PRP-T at another site.74 Similar results (i.e., lower antibody titers elicited by tetanus toxoid adsorbed and pertussis antigens) were observed in another study in infants who received DTP combined with IPV and PRP-T in the same syringe at a single site or a fixed combination vaccine of DTP and IPV at a single site (without PRP-T).75 Although the clinical relevance of this difference in antibody response is unclear,74 a protective response generally is attained when DTP, IPV, and PRP-T are administered in the same syringe.75

Hepatitis B Vaccine

IPV may be administered concomitantly with hepatitis B vaccine using different syringes and different injection sites.1,105,134,199 Alternatively, IPV is commercially available in fixed combination with DTaP and hepatitis B vaccine (DTaP-HepB-IPV; Pediarix^®).106 Depending on the age and vaccination status of the child, this combination vaccine can be used instead of separate injections of DTaP and hepatitis B vaccine when indicated and if there are no contraindications to any of the individual components.106 (See Combination Vaccines Containing IPV and Other Antigens under Primary Immunization: Infants and Children, in Uses.)

Pneumococcal Vaccines

IPV may be administered concurrently with pneumococcal 13-valent conjugate vaccine (PCV13; Prevnar 13^®) or pneumococcal 23-valent vaccine (PPSV23; Pneumovax^® 23) using separate syringes and injection sites.105,134

In clinical studies evaluating PCV13 (Prevnar 13^®) in infants, the pneumococcal vaccine was administered concurrently with the first 3 doses of a fixed-combination vaccine containing IPV (DTaP-HepB-IPV; Pediarix^®) at 2, 4, and 6 months of age.181

Live Vaccines

Measles, Mumps, Rubella, and Varicella Virus Vaccines Live

IPV can be given concurrently at separate sites with age-appropriate live viral vaccines, including measles, mumps, and rubella virus vaccine live (MMR) and varicella virus vaccine live.9,105,134

Rotavirus Vaccine

Rotavirus vaccines (Rotarix^®, RotaTeq^®) have been administered concomitantly with IPV without a decrease in immune response to either vaccine.176,177,178 Oral rotavirus vaccine may be administered concomitantly with or at any interval before or after IPV.134

Other Information ⬆ ⬇

[Section Outline]

Polioviruses and Poliovirus Infection
Response to IPV
Duration of Immunity
Chemistry
Stability

Pharmacology

Poliovirus vaccine inactivated (IPV) stimulates active immunity to poliovirus infection.1,2,93,44,129 IPV contains inactivated poliovirus type 1 (Mahoney strain), poliovirus type 2 (MEF-1 strain), and poliovirus type 3 (Saukett strain) and principally induces humoral immunity by eliciting production of specific antipoliovirus antibodies.1,16,44,64,117 The specific antibodies bind to antigenic sites on wild-type poliovirus and neutralize the virus preventing it from spreading to the CNS.19,55,59,117 The immunologic response following administration of IPV is not identical to that following administration of poliovirus vaccine live oral (OPV; no longer commercially available in the US).7,44,93,111,113,117 Although both vaccines stimulate similar humoral responses and stimulate local secretory (mucosa) IgA antibody responses, OPV induces a local secretory (mucosal) immune response that is more extensive than that induced by IPV.3,7,17,19,28,41,42,43,44,58,93,111,113,117,129 (See Pharmacology: Response to IPV.) Although the clinical importance has not been fully elucidated, the antigenic structure of the inactivated poliovirus type 3 contained in IPV differs slightly from wild-type poliovirus type 3 and from the type 3 strain used in OPV.59,64

Polioviruses and Poliovirus Infection

Polioviruses are RNA viruses belonging to the genus Enterovirus .16,56,105,166 They are closely related to other enteroviruses such as Coxsackie A and Coxsackie B viruses, Echoviruses, and Enteroviruses 68-71.16,56,105 Although there are 3 immunologically defined poliovirus serotypes (poliovirus types 1, 2, and 3), there are a variety of subtypes.9,56,57 Acute paralytic poliomyelitis may be caused by naturally occurring (wild-type) polioviruses or by circulating vaccine-derived polioviruses (cVDPVs) that have acquired virulence properties (neurovirulence and transmissibility).105,183,184 In addition, vaccine-associated paralytic poliomyelitis (VAPP) can occur in recipients of OPV or their close contacts.105 VAPP is a rare event that occurs sporadically when OPV is administered and the vaccine virus reverts to neurovirulence and causes paralysis in the vaccine recipient or a nonimmune contact.184 Poliovirus type 1 is the most frequent cause of wild-type paralytic infections and the most frequent cause of wild-type poliomyelitis epidemics.129 Poliovirus types 2 and 3 are the most frequent causes of VAPP related to use of OPV.56,87,93

Polioviruses generally are transmitted by the fecal-oral route and acquired by ingestion, but can be acquired by inhalation.1,9,16,44,57,105,129,166 In developed countries with good hygienic conditions, infection most frequently occurs via droplet infection (e.g., through salivary contamination, coughing);16,139 in developing countries with less hygienic conditions, infection probably occurs via fecal contact.16 Poliovirus infection most commonly occurs in infants and young children under 5 years of age,105,129,169 70-90% of reported cases of naturally occurring poliomyelitis occur in individuals younger than 3 years of age.129 In temperate climates, poliovirus infections are most common in the summer and fall; however, in the tropics, the seasonal pattern is variable and less predictable.105,129,166

Following infection, polioviruses multiply in the pharynx and intestines and spread to the blood and lymphatic system.16,19,57,166 If viremia persists, the viruses subsequently can invade the CNS, eventually destroying motorneurons and causing flaccid paralysis of a single limb to quadriplegia, respiratory failure, and rarely death.16,19,57,166 Initial symptoms from poliovirus infection include fever, fatigue, headache, vomiting, stiffness in the neck, and pain in the limbs and usually begin 1-3 weeks after exposure.9,16,105,129,139 The incubation period following infection ranges from 3-35 days.9,16,105,129,139,105 For nonparalytic poliomyelitis, the incubation period usually is 3-6 days;105,166 for the onset of paralysis in paralytic poliomyelitis, the incubation period usually is 7-21 days.105,166 The period of greatest communicability is shortly before and after the onset of clinical illness when the virus is present in the throat (about 1-2 weeks) and is being excreted in high concentrations in the feces (from 2 weeks to 2 months).9,44,105

Poliovirus infection can range from minor illness to fatal infections.57,105,166 The majority of infected individuals (72-95%) are asymptomatic;1,9,16,105,129,166 these individuals may shed virus in the stool and are able to transmit the virus to others.166 About 24% of infections consist of nonspecific flu-like symptoms (e.g., low-grade fever and sore throat) without clinical or laboratory evidence of CNS invasion;105,166 these infections are characterized by complete recovery in less than a week and are known as abortive poliomyelitis.105,166 Nonparalytic aseptic meningitis (sometimes with paresthesia) occurs in 1-5% of patients, usually within a few days after a prodrome similar to that of minor illness;1,16,105,166 symptoms typically last 2-10 days and are followed by complete recovery.166

In less than 2% of poliovirus infections, there is rapid onset of asymmetric acute flaccid paralysis with areflexia of the involved limb.1,105,129,166 Paralytic symptoms in these patients usually begin 1-18 days after prodromal symptoms and progress for 2-3 days.166 Residual paralytic disease involving the motor neurons (paralytic poliomyelitis) occurs in approximately 66% of individuals with acute motor neuron disease.16,105 The case-fatality rate for paralytic polio generally is 2-5% among children and up to 15-30% among adults,166 but is 25-75% in patients who have bulbar involvement.166 Approximately 25-40% of individuals who contracted paralytic poliomyelitis during childhood develop a postpolio syndrome 15-40 years later;9,105,166 the postpolio syndrome is noninfectious and is characterized by slow and irreversible exacerbation of weakness, usually occurring in muscle groups involved during the original infection, and muscle and joint pain.9,105,166

Response to IPV

Although the immunologic response to IPV initially was evaluated using inactivated poliovirus vaccines with less than optimal potencies, additional studies have been performed to evaluate the immune response to various enhanced-potency IPV vaccines produced using viral strains propagated in human diploid cells, primary monkey kidney cells, and VERO cells.1,2,3,14,26,28,54,58,82,83,110,117,119,137

Results of studies using IPV vaccines with potencies similar to the vaccine available for use in the US indicate that administration of 2 doses (at 2 and 4 months of age) or 3 doses (at 2, 4, and 12 or 18 months of age) results in seroconversion and high titers of specific serum antibodies against poliovirus types 1, 2, and 3 in 98-100% of healthy infants and children.1,2,28,58,83,93,129 The seroconversion rate following administration of a single dose of the vaccine appears to depend on the age of the infant and the presence or absence of maternal antibody.14,124 The seroconversion rate in infants younger than 6 months of age who receive a single IPV dose is highly variable (27-90%) and difficult to assess since maternal antibody may be present.2,14,28,40,58,83,117 When a single dose of IPV is administered at 6 months of age or older, the seroconversion rate has been reported to be 90% or greater.124

IPV induces the production of neutralizing antibodies against each type of virus, which are related to protective efficacy.1 In addition to a humoral response, IPV elicits some local IgA antibody production, principally in the pharynx.19,44,51,52,58,93,111,113,114 This local response is not as extensive as that seen with OPV since replication of the live, attenuated viruses following oral administration of OPV stimulates the production of secretory (mucosal) IgA antibody in both nasopharyngeal and intestinal secretions.7,17,19,44,58,93,111,113,129 A local immune response is considered to be important in reducing the rate of transmission of wild-type polioviruses from immune individuals.17,44,113,114 While the local immunity induced by IPV may be sufficient to decrease pharyngeal shedding of the virus and block respiratory spread of wild-type poliovirus, it has little effect on fecal excretion of the virus.1,28,41,42,43,44,111,113,114,129 Although the effect of IPV on herd immunity and on reducing circulation of wild-type virus in the community has not been fully elucidated, there is some evidence that IPV contributes to herd immunity in countries and populations with high levels of hygiene where transmission of the virus occurs principally via droplet infection.41,44,114 It has been suggested that IPV may be less effective in reducing circulation of wild-type virus in countries or populations where the fecal-oral route of poliovirus transmission predominates.41,44,114

In one study in healthy children designed to compare the immunologic response of primary immunization with 3 doses of IPV (IPV-IPV-IPV), 3 doses of OPV (OPV-OPV-OPV), or sequential regimens using a combination of the vaccines (IPV-OPV-OPV or IPV-IPV-OPV), doses were administered at 2, 4, and 12 months of age.2 Results indicate that 2 doses of either IPV or OPV or a dose of IPV followed by OPV induce detectable serum antibodies to all 3 poliovirus types in more than 94% of children.2 After the third dose, high serum antibody concentrations to all 3 poliovirus types were present in 95-100% of vaccinees; however, mean serum antibody titers varied considerably among the groups.2 IPV-IPV-OPV induced the greatest serum antibody response to poliovirus type 1, IPV-OPV-OPV induced the greatest response to poliovirus type 2, and IPV-IPV-IPV induced the greatest response to poliovirus type 3.2 Local immune responses (as measured by neutralizing and IgA antibody titers in nasopharyngeal specimens) after the first dose were highest in vaccinees who received OPV; however, after the third dose, antibody titers in nasopharyngeal specimens in those who received OPV-OPV-OPV were not substantially greater than in those who received IPV-OPV-OPV.2 In the group of infants who received OPV-OPV-OPV, 29% shed polioviruses in feces 2 months after the first OPV dose, 43% shed the viruses 1 month after the second dose, and 13% shed the viruses after the third dose.2 In the group who received IPV-OPV-OPV, fecal shedding of polioviruses occurred in 62% 1 month after the second vaccine dose (first dose of OPV) and in 14% after the third vaccine dose (second dose of OPV).2 In one British study comparing results in children who received a single IPV dose followed by 2 OPV doses with those in children who received 3 doses of OPV at 2, 3, and 4 months of age, detectable antibody levels to poliovirus types 1, 2, and 3 were similar in both groups and the rate of viral excretion of type 3 poliovirus following the second dose of vaccine was less in children who had received IPV for the first dose than in those who had received OPV.128

The immunologic response to IPV may be reduced in individuals with altered immunocompetence, including patients with human immunodeficiency virus (HIV) infection.65 In one study in HIV-infected adults who were immune to poliomyelitis, administration of a single booster dose of IPV resulted in a marked increase in serum antibody titers in those with absolute helper/inducer (CD4⁺, T4⁺) T-cell counts exceeding 200/mm³ but not in those with lower T-cell counts.66 In another study in hemophilic patients 6-40 years of age who were immune to poliomyelitis as the result of prior immunization, administration of a single dose of IPV resulted in similar immune responses in patients who were either seronegative for HIV or seropositive with asymptomatic HIV infection; however, there was no evidence of an immunologic response to the IPV dose in hemophilic patients who had symptomatic HIV infection.65

Duration of Immunity

The duration of immunity following primary immunization with IPV is not known,115,166 but probably is prolonged and may be lifelong.105,115,166

There is evidence from studies evaluating previously available IPV vaccines that serum antibody levels induced by the vaccine tend to decline during the first year following vaccination, but then are maintained at a lower level for at least 6-12 years.2,38,43,47,82,83 In a study in children who received primary immunization with 3 doses of IPV, 3 doses of OPV, or a sequential regimen that included 1 or 2 doses of IPV followed by OPV, serum antibody titers decreased during the first 2 years and then remained stable for the next 2 years following all 4 regimens.38

Administration of an additional dose of IPV or OPV in individuals who previously received primary immunization with either IPV or OPV alone or with sequential regimens that include both vaccines generally results in a booster effect and rapid increases in serum antibody titers.4,5,38,43,54

Chemistry and Stability

Chemistry

IPV

Poliovirus vaccine inactivated (IPV) is a noninfectious, sterile suspension containing 3 strains of inactivated poliovirus: type 1 (Mahoney strain), type 2 (MEF-1 strain), and type 3 (Saukett strain).1,9,135,139 Various formulations of IPV vaccines have been available worldwide, and international standards have permitted use of various viral strains with acceptable immunogenic potential and various cell culture substrates for propagation of the virus.1,2,3,14,26,28,54,58,82,83,109,110,117,119,135

IPV commercially available for use in the US (IPOL^®) is prepared using VERO cells (a continuous line of monkey kidney cells) and a microcarrier culture technique.1,9,135 The poliovirus strains are propagated separately in cultures of VERO cells, harvested, concentrated, purified, inactivated with formaldehyde, and suspended in a phosphate-buffered sodium chloride solution.1,9,135 The VERO cells are grown in Eagle MEM modified medium, supplemented with newborn calf serum that has been tested for adventitious agents prior to use and originates from countries free of bovine spongiform encephalopathy (BSE).1 For viral growth, the culture medium is replaced by M-199, without calf serum.1 After clarification and filtration, viral suspensions are concentrated by ultrafiltration and purified by 3 liquid chromatography steps (2 anion exchange columns and a gel filtration column).1 After reequilibration of the purified viral suspension with M-199 and adjustment of the antigen titer, the monovalent viral suspensions are inactivated with 1:4000 formaldehyde at temperatures exceeding 37°C for at least 12 days.1 Each 0.5-mL dose of IPV contains phenoxyethanol 0.5% and formaldehyde 0.02% or less as preservatives.1 IPV does not contain thimerosal.1 Anti-infectives are added during the manufacturing process; although purification procedures eliminate measurable amounts, less than 200, 25, and 5 ng of streptomycin, polymyxin B, and neomycin, respectively, may remain in each 0.5-mL dose of IPV.1 IPV occurs as a clear, colorless suspension.1

IPV commercially available for use in the US meets standards established by the Center for Biologics Evaluation and Research of the US Food and Drug Administration.135 Potency of the vaccine meets requirements of the specific monkey potency test by virus neutralizing antibody production based on comparison with the US reference poliovirus antiserum preparation and is expressed in terms of the D antigen content.1,17,64,110 The D antigen is one of two major antigenic components of intact polioviruses (the other is the C antigen) and is considered the primary epitope.64,110 The IPV vaccine commercially available for use in the US has enhanced potency and contains an increased amount of antigen per dose compared with formulations available for use in the US prior to 1988.1,17,19,26,93,109,110,149 The D-antigen content of each lot of IPV is determined in vitro using the D-antigen enzyme-linked immunosorbent assay (ELISA).1 Each 0.5-mL dose of IPV commercially available for use in the US contains 40 D antigen units (DU) of poliovirus type 1, 8 DU of poliovirus type 2, and 32 DU of poliovirus type 3.1,110

Although no extraneous protein capable of producing allergenic effects in humans is added to the final virus production medium for IPV,135,138 there is a possibility that small quantities of residual DNA may be present in the vaccine.138,139 The concentration of residual calf protein does not exceed 1 part per million.1 Prior to inactivation, the virus harvests are tested to ensure the absence of active poliovirus using specific tissue culture and monkey tests, the absence of B virus and Mycobacterium tuberculosis using specific mouse, guinea pig, and monkey tests; the absence of SV-40 virus using specific tissue culture tests; the absence of lymphocyte choriomeningitis virus using the mouse test; and the absence of other active viruses using the tissue culture safety test.135

Combination Vaccines Containing IPV and Other Antigens

DTaP-IPV (Kinrix®)

DTaP-IPV (Kinrix^®) is a fixed-combination vaccine containing diphtheria, tetanus, pertussis, and poliovirus antigens.223

The diphtheria, tetanus, and pertussis antigens contained in Kinrix^® are identical to those contained in Infanrix^® diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DTaP) vaccine and in Pediarix^® (DTaP-HepB-IPV) vaccine.223 For information about these DTaP antigens, see Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed/Tetanus Toxoid and Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed 80:08.

After vigorous shaking, Kinrix^® occurs as a homogeneous, turbid, white suspension.223 Each 0.5-mL dose of Kinrix^® is formulated to contain 25 Lf of diphtheria toxoid, 10 Lf of tetanus toxoid, 58 mcg of pertussis antigens, 40 DU of Type 1 poliovirus, 8 DU of Type 2 poliovirus, and 32 DU of Type 3 poliovirus.223 Each 0.5 mL of Kinrix^® also contains 4.5 mg sodium chloride, not more than 0.6 mg of aluminum adjuvant, not more than 100 mcg of polysorbate 80, and not more than 100 mcg of residual formaldehyde.223 Although neomycin and polymyxin B are used in the manufacturing process of the poliovirus antigen component, Kinrix^® contains no more than 0.05 and 0.01 ng, respectively, of these anti-infectives per dose.223 Kinrix^® does not contain thimerosal or any other preservatives.223

DTaP-IPV (Quadracel®)

DTaP-IPV (Quadracel^®) is a fixed-combination vaccine containing diphtheria, tetanus, pertussis, and poliovirus antigens.221

The pertussis antigens contained in Quadracel^® are identical to those contained in DTaP (Daptacel^®).221 For information about DTaP antigens, see Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed/Tetanus Toxoid and Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed 80:08.

After shaking, Quadracel^® occurs as a uniform, white, cloudy suspension.221 Each 0.5-mL dose of Quadracel^® is formulated to contain 15 Lf of diphtheria toxoid, 5 Lf of tetanus toxoid, 48 mcg of pertussis antigens, 40 DU of Type 1 poliovirus, 8 DU of Type 2 poliovirus, and 32 DU of Type 3 poliovirus.221 Each 0.5 mL of Quadracel^® also contains 1.5 mg aluminum phosphate adjuvant (0.33 mg aluminum), approximately 10 ppm of polysorbate 80, not more than 5 mcg of residual formaldehyde, less than 50 ng of residual glutaraldehyde, no more than 50 ng of residual bovine serum albumin, 3.3 mg of 2-phenoxyethanol (not as a preservative), less than 4 pg of neomycin, and less than 4 pg of polymyxin B sulfate.221 Quadracel^® does not contain thimerosal or any other preservatives.221

DTaP-HepB-IPV (Pediarix®)

DTaP-HepB-IPV (Pediarix^®) is a fixed-combination vaccine containing diphtheria, tetanus, pertussis, hepatitis B, and poliovirus antigens.106

The diphtheria, tetanus, and pertussis antigens contained in Pediarix^® are identical to those contained in Infanrix^® (DTaP) vaccine and in Kinrix^® (DTaP-IPV) vaccine.106,223 For information on these DTaP antigens, see Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed/Tetanus Toxoid and Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed 80:08. The hepatitis B antigen contained in Pediarix^® is identical to that contained in Engerix-B^® hepatitis B vaccine.106 For information on this hepatitis B antigen, see Hepatitis B Vaccine 80:12.

After vigorous shaking, Pediarix^® occurs as a homogeneous, turbid, white suspension.106 Each 0.5-mL dose of Pediarix^® is formulated to contain 25 Lf of diphtheria toxoid, 10 Lf of tetanus toxoid, 58 mcg of pertussis antigens, 10 mcg of HBsAg, 40 DU of Type 1 poliovirus, 8 DU of Type 2 poliovirus, and 32 DU of Type 3 poliovirus.106 Each 0.5 mL of Pediarix^® contains 4.5 mg sodium chloride, not more than 0.85 mg of aluminum adjuvant, not more than 100 mcg of polysorbate 80, and not more than 100 mcg of residual formaldehyde.106 Although neomycin and polymyxin B are used in the manufacturing process of the poliovirus antigen component, Pediarix^® contains no more than 0.05 and 0.01 ng, respectively, of these anti-infectives per dose.106 No more than 5% yeast protein may be present in Pediarix^® as part of the hepatitis B antigen component.106 Pediarix^® does not contain thimerosal or any other preservatives.106

DTaP-IPV/Hib (Pentacel®)

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 Haemophilus influenza type b (Hib) polysaccharide (tetanus toxoid conjugate) vaccine (ActHIB^®).224 The DTaP-IPV vaccine in the kit is used to reconstitute the Hib vaccine in 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 amount of PT and FHA antigens in Pentacel^® are twofold and fourfold higher, respectively, than that contained in Daptacel^®.224 For information on these DTaP antigens, see 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 Hib antigens, see Haemophilus b Vaccine 80:12.

Following reconstitution, each 0.5-mL of Pentacel^® contains 15 Lf of diphtheria toxoid, 5 Lf of tetanus toxoid, 48 mcg of pertussis antigens, 40 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 Pentacel^® 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 and polymyxin B are used in the manufacturing process of the poliovirus antigen component, Pentacel^® contains less than 4 pg of each anti-infective per dose.224

Stability

IPV

IPV should be refrigerated at 2-8°C,1 protected from light,1 and should not be frozen.1 Potency of IPV is destroyed by freezing.138 Of the 3 types of poliovirus contained in IPV, type 1 is the most susceptible to thermal degradation.110

Combination Vaccines Containing IPV and Other Antigens

DTaP-IPV (Kinrix^®) should be stored at 2-8°C and should not be frozen.223 If freezing occurs, the vaccine should be discarded.223

DTaP-IPV (Quadracel^®) should be stored at 2-8°C and should not be frozen.221 If freezing occurs, the vaccine should be discarded.221

DTaP-HepB-IPV (Pediarix^®) should be refrigerated at 2-8°C and should not be frozen.106 If freezing occurs, the vaccine should be discarded.106

The commercially available kit containing a fixed-combination vaccine containing DTaP-IPV vaccine and 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 Pentacel^® 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.

Poliovirus Vaccine Inactivated (IPV)

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Injectable suspension, for IM or subcutaneous use	40 D antigen units (DU) of Type 1 (Mahoney), 8 DU of Type 2 (MEF-1), and 32 DU of Type 3 (Saukett) per 0.5 mL	IPOL^®	Sanofi Pasteur

Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine (DTaP-IPV)

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Injectable suspension, for IM use	Diphtheria Toxoid 15 Lf units, Tetanus Toxoid 5 Lf units, Acellular Pertussis Vaccine 48 mcg (of pertussis antigen) and Poliovirus Type 1 40 DU, Poliovirus Type 2 8 DU, and Poliovirus Type 3 32 DU per 0.5 mL	Quadracel^®	Sanofi Pasteur
		Diphtheria Toxoid 25 Lf units, Tetanus Toxoid 10 Lf units, Acellular Pertussis Vaccine 58 mcg (of pertussis antigen) and Poliovirus Type 1 40 DU, Poliovirus Type 2 8 DU, and Poliovirus Type 3 32 DU per 0.5 mL	Kinrix^®	GlaxoSmithKline

Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (DTaP-HepB-IPV)

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Injectable suspension, for IM use	Diphtheria Toxoid 25 Lf units, Tetanus Toxoid 10 Lf units, Acellular Pertussis Vaccine 58 mcg (of pertussis antigen), Hepatitis B Surface Antigen 10 mcg, Poliovirus Type 1 40 DU, Poliovirus Type 2 8 DU, and Poliovirus Type 3 32 DU per 0.5 mL	Pediarix^®	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, Haemophilus b Polysaccharide 10 mcg, Tetanus Toxoid 24 mcg 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, Haemophilus b Polysaccharide 10 mcg, Tetanus Toxoid 24 mcg per 0.5 mL, ActHIB^®

Pentacel^®

Sanofi Pasteur

AHFS^® Drug Information. © Copyright, 1959-2024, Selected Revisions August 10, 2024. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, MD 20814.

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

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section name header

Introduction ⬇

AHFS Class:

Generic Name(s):

Uses ⬆ ⬇

Dosage and Administration ⬆ ⬇

Cautions ⬆ ⬇

Drug Interactions ⬆ ⬇

Other Information ⬆ ⬇

Preparations ⬆ ⬇

Poliovirus Vaccine Inactivated (IPV)

Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine (DTaP-IPV)

Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (DTaP-HepB-IPV)

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

Copyright ⬆ ⬇

References ⬆