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Poliovirus Vaccine Inactivated

Class: Vaccines
ATC Class: J07BF03
VA Class: IM100
Brands: IPOL, Kinrix (combination), Pediarix, Pentacel (combination)

Introduction

Inactivated virus vaccine.1 9 101 135 Poliovirus vaccine inactivated (IPV) contains 3 strains of inactivated poliovirus (types 1, 2, and 3) and is used to stimulate active immunity to poliovirus.1 9 97 98 100 135 Also commercially available in fixed combination with diphtheria, tetanus, and pertussis antigens (DTaP-IPV; Kinrix),167 in fixed combination with diphtheria, tetanus, pertussis, and hepatitis B virus antigens (DTaP-HepB-IPV; Pediarix),106 and in combination with diphtheria, tetanus, pertussis, and Haemophilus influenza type b (Hib) antigens (DTaP-IPV/Hib; Pentacel).168 Other poliovirus vaccines (e.g., poliovirus vaccine live oral [OPV]; no longer commercially available in the US) may be available in other countries.9 101 102 164

Uses for Poliovirus Vaccine Inactivated

Prevention of Poliomyelitis

Prevention of poliomyelitis caused by poliovirus types 1, 2, and 3 in infants ≥6 weeks of age, children, adolescents, and adults.1

Poliomyelitis is an acute viral infection that involves the GI tract and occasionally the CNS.9 97 Poliovirus infection is spread by the fecal-oral and respiratory routes.1 9 44 57 97 105 129 166 Most poliovirus infections are asymptomatic or result in nonspecific flu-like symptoms.1 9 97 105 129 Aseptic meningitis reported in ≤5% of patients within a few days after minor illness had subsided.1 97 Rapid onset of asymmetric acute flaccid paralysis reported in ≤2% of infections;1 97 129 residual paralytic disease occurs in some patients.1 9 97 There were approximately 600,000 cases of paralytic poliomyelitis worldwide and ≥10,000–20,000 cases in the US each year before poliovirus vaccines became available.9 93 95 104 129 Wild-type poliovirus infection has been eliminated in the US.9 17 19 41 43 44 86 91 93 95 97 100 Efforts are ongoing to eradicate poliomyelitis worldwide.9 102 164 181

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USPHS Advisory Committee on Immunization Practices (ACIP), AAP, and American Academy of Family Physicians (AAFP) recommend that all infants and children receive primary immunization against poliomyelitis initiated at 2 months of age, unless contraindicated.9 97 145 153 (See Contraindications under Cautions.)

ACIP, AAP, and AAFP also recommend catch-up vaccination for all children and adolescents ≤17 years of age who are unvaccinated or incompletely vaccinated against poliomyelitis.97

For internationally adopted children whose immune status is uncertain, vaccinations can be repeated or serologic tests performed to confirm immunity.101 For IPV, ACIP states that the simplest approach is to revaccinate according to the US recommended immunization schedule.101 (See Dosage and Administration.) Alternatively, serologic tests for neutralizing antibody to poliovirus can be performed if available; revaccination is unnecessary in those with protective titers to all 3 poliovirus types.101

ACIP and AAP do not recommend routine immunization against poliomyelitis in immunocompetent adults.9 97 98 145 175

ACIP and others state that previously unvaccinated adults at increased risk of exposure to poliovirus should receive IPV.9 97 98 102 152 This includes all travelers to areas where poliomyelitis is endemic or epidemic (including countries with recent proven wild poliovirus circulation and neighboring countries), health-care personnel in close contact with patients who may be excreting wild-type polioviruses, laboratory personnel handling specimens that may contain polioviruses, and members of communities or specific population groups with disease caused by wild-type poliovirus.1 9 97 102 109 150 152 Adults at increased risk who do not have documentation of vaccination status should be considered unvaccinated.9

Immunocompromised individuals, including those with HIV infection, may be vaccinated against poliovirus using IPV.1 97 101 102 103 151 169 170 The fact that the vaccine may be less immunogenic in immunocompromised individuals should be considered.1 97 101 102 103 106 109 150 151 168 (See Individuals with Altered Immunocompetence under Cautions.)

Depending on age and vaccination status, IPV may be given as a monovalent vaccine (IPOL)1 or as a fixed-combination vaccine containing IPV and other antigens.106 167 168 ACIP states that use of a combination vaccine generally is preferred over separate injections of the equivalent component vaccines;180 considerations should 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.180

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).167

The commercially available fixed-combination vaccine containing diphtheria, tetanus, pertussis, hepatitis B, and poliovirus antigens (DTaP-HepB-IPV; Pediarix) can be used as a 3-dose series for immunization in infants and children 6 weeks through 6 years of age born to HBsAg-negative women when doses of IPV, DTaP, and HepB vaccine are indicated and there are no contraindications to any of the individual components.106 ACIP states this fixed-combination vaccine also may be used to complete the HepB vaccination series in infants 6 weeks through 6 years of age born to HBsAg-positive women.162 Pediarix should not be used for the initial dose of HepB vaccine that is indicated in neonates.97 106 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

The combination vaccine containing diphtheria, tetanus, pertussis, poliovirus, and Haemophilus b (Hib) antigens (DTaP-IPV/Hib; Pentacel) can be used as a 4-dose series for immunization in infants and children 6 weeks through 4 years of age when doses of IPV, DTaP, and Hib vaccine are indicated and there are no contraindications to any of the individual components.168 173 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.168 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,168 173 data are not available on safety and immunogenicity in such infants and children.168

Poliovirus Vaccine Inactivated Dosage and Administration

Administration

IPV (IPOL) is administered by IM or sub-Q injection.1 Do not administer IV.1

DTaP-IPV (Kinrix), DTaP-HepB-IPV (Pediarix), and DTaP-IPV/Hib (Pentacel) are administered by IM injection.106 167 168 Do not administer these combination vaccines sub-Q, IV, or intradermally.106 167 168

May be given simultaneously with other age-appropriate vaccines during the same health-care visit (using different syringes and different injection sites).101 167 168 173 When multiple vaccines are administered during a single health-care visit, separate injection sites by at least 1 inch (if anatomically feasible) to allow appropriate attribution of any local adverse effects that may occur.101

IPV (IPOL)

Administer IPV (IPOL) by IM injection or by sub-Q injection.1 98 101

Shake vaccine well immediately prior to administration.165 IPOL should be clear and colorless.1

Do not mix with any other vaccine or solution.101

Since syncope may occur following vaccination, observe vaccinees for approximately 15 minutes after the vaccine dose.101 If syncope occurs, observe patient until symptoms resolve.101 Syncope after vaccination occurs most frequently in adolescents and young adults.101

IM Injection

Depending on patient age, administer IM into the deltoid muscle or anterolateral thigh.1 101 168 For adults and adolescents, administer IM into the deltoid muscle.1 101 In children ≥3 years of age, IM injections should be made into the deltoid muscle if muscle mass is adequate; alternatively, the anterolateral thigh can be used.1 101 168 In children ≤2 years of age, IM injections should preferably be made in the anterolateral aspect of the thigh.1 101 168

To ensure delivery into muscle, IM injections should be made at a 90° angle to the skin using a needle length appropriate for the individual’s age and body mass, the thickness of adipose tissue and muscle at the injection site, and the injection technique.101 171 172 Consider anatomic variability, especially in the deltoid, and use clinical judgement to avoid inadvertent underpenetration or overpenetration of muscle.171 172

Generally do not administer vaccines into buttock muscle in children because of potential for injection-associated injury to sciatic nerve.101

Although some experts state that aspiration (i.e., pulling back on the syringe plunger after needle insertion and before injection) can be performed to ensure that a blood vessel has not been entered, ACIP and AAP state this procedure is not required because large blood vessels are not present at recommended IM injection sites.101

Sub-Q Injection

Depending on patient age, administer sub-Q into the upper-outer triceps area or anterolateral thigh.101 For infants <1 year of age, sub-Q injections should preferably be administered into the anterolateral thigh; sub-Q injections can also be administered into the upper-outer triceps of an infant, if necessary.101 For children ≥1 year of age, adolescents, and adults, the upper-outer triceps area is preferred.101

To ensure appropriate delivery, sub-Q injections should be made at a 45° angle using a 5/8-inch, 23- to 25-gauge needle.101

Combination Vaccines Containing IPV and Other Antigens

Administer DTaP-IPV (Kinrix), DTaP-HepB-IPV (Pediarix), and DTaP-IPV/Hib (Pentacel) by IM injection.106 167 168

Shake vaccine well immediately prior to administration to provide a uniform, turbid, white suspension.106 167 168 Discard vaccine if it contains particulates, appears discolored, or cannot be resuspended with thorough agitation.106 167 168

Do not mix Kinrix, Pediarix, or any component of Pentacel with any other vaccine or solution.101 106 167

IM Injection

Depending on patient age, administer by IM injection into the deltoid muscle or anterolateral thigh.101 106 168 In children ≥3 years of age, IM injections should be made into the deltoid muscle if muscle mass is adequate; alternatively, the anterolateral thigh can be used.101 106 168 In children ≤2 years of age, the preferred site for IM injection is the anterolateral aspect of the thigh.101 106 168

Vaccines generally should not be administered into buttock muscle in children because of the potential for injection-associated injury to sciatic nerve.101

To ensure delivery into muscle, IM injections should be made at a 90° angle to the skin using a needle length appropriate for the individual’s age and body mass, the thickness of adipose tissue and muscle at the injection site, and the injection technique.101 171 172 Consider anatomic variability, especially in the deltoid, and use clinical judgement to avoid inadvertent underpenetration or overpenetration of muscle.171 172

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).168

Prior to administration, reconstitute a vial of lyophilized ActHIB vaccine by adding the entire contents of a vial of the DTaP-IPV vaccine according to manufacturer's instructions to provide a combined preparation containing diphtheria, tetanus, pertussis, IPV, and Hib antigens.168 Shake thoroughly until a cloudy, uniform suspension is obtained.168

Administer Pentacel immediately after reconstitution.168

Dosage

Dosing schedule varies according to the individual's age and immunization status.1 9 97 145

IPV (IPOL) is used in adults, adolescents, and infants and children ≥6 weeks of age.1

DTaP-IPV (Kinrix) is used only in children 4 years through 6 years of age,167 DTaP-HepB-IPV (Pediarix) is used only in infants and children 6 weeks through 6 years of age,106 and DTaP-IPV/Hib (Pentacel) is used only in infants and children 6 weeks through 4 years of age.168

The complete IPV vaccine series must be administered to ensure optimal protection.101

Medically stable preterm and low-birthweight infants generally should be vaccinated at the usual chronologic age using usual dosage.97 101 (See Pediatric Use under Cautions.)

Interruptions resulting in an interval between doses longer than recommended should not interfere with the final immunity achieved; there is no need to administer additional doses or start the vaccination series over.1 97 101 145

Pediatric Patients

Prevention of Poliomyelitis
Infants and Children 6 Weeks through 6 Years of Age (IPV; IPOL)
IM or Sub-Q

Each dose is 0.5 mL.1

Primary immunization consists of a series of 4 doses.1 9 97 145 179

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

ACIP, AAP, and AAFP recommend that IPV doses be given at 2, 4, 6 through 18 months, and 4 through 6 years of age.9 97 145 179 If a dose was not given at 4–6 years of age, give a booster dose as soon as feasible.179

Initial dose may be given as early as 6 weeks of age,1 97 102 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.97 145 179 However, a fourth dose is not necessary if the third dose was given at ≥4 years of age and at least 6 months after the previous dose.145

Stem cell recipients: Optimum regimen not identified; AAP recommends a 3-dose series with doses given at 12, 14, and 24 months after transplant.97

Children and Adolescents 7 through 18 Years of Age (IPV; IPOL)
IM or Sub-Q

Each dose is 0.5 mL.1

Primary immunization or catch-up vaccination consists of a series of 4 doses.1 9 97 145

Minimum interval between first and second IPV dose and between second and third IPV dose is 4 weeks; minimum interval between third and fourth IPV dose is 6 months.179

Incompletely vaccinated individuals: Give remaining doses to complete the 4-dose primary vaccination series.1 9 97

Stem cell recipients: Optimum regimen not identified; AAP recommends a 3-dose series with doses given at 12, 14, and 24 months after transplant.97

Infants and Children 6 Weeks through 4 Years of Age (DTaP-IPV/Hib; Pentacel)
IM

Each dose is 0.5 mL.168

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.168 173

In previously unvaccinated infants and children 6 weeks through 4 years of age, Pentacel is given in a series of 4 doses.168 Give doses at 2, 4, 6, and 15 through 18 months of age.168 Initial dose usually given at 2 months of age, but may be given as early as 6 weeks of age.168

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, give an additional booster dose of age-appropriate vaccine containing IPV (IPOL or Kinrix) at 4 through 6 years of age.168 179 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, give a fifth dose of DTaP (Daptacel) at 4 through 6 years of age.168 Pentacel should not be used for the booster dose of DTaP indicated at 4 through 6 years of age; however, if a dose of Pentacel is inadvertently given to a child ≥5 years of age, ACIP states the dose may be counted as a valid dose.173

In infants and 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 if doses of DTaP and Hib vaccine also are indicated and there are no contraindications to any of the individual components.168 173

In infants and 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 series if doses of IPV and Hib vaccine also are indicated and there are no contraindications to any of the individual components.168 173

In infants and 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 also are indicated and there are no contraindications to any of the individual components.168 173 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.168

Infants and Children 6 Weeks through 6 Years of Age (DTaP-HepB-IPV; Pediarix)
IM

Each dose is 0.5 mL.106

May be used when immunization against diphtheria, tetanus, pertussis, hepatitis B, and poliovirus is indicated in infants and children 6 weeks through 6 years of age born to HBsAg-negative women.106 ACIP states this fixed-combination vaccine also may be used in infants 6 weeks through 6 years of age born to HBsAg-positive women.162

In previously unvaccinated infants and children 6 weeks through 6 years of age, Pediarix is given in a series of 3 doses.106 Give doses at 2, 4, and 6 months of age (at 6- to 8-week intervals, preferably 8-week intervals).106 Initial dose usually 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, administer a dose of monovalent IPV (IPOL) at 4 through 6 years of age.106 145

To complete the recommended primary and booster regimen against diphtheria, tetanus, and pertussis in children who received a 3-dose series of Pediarix, administer a fourth or fifth dose of DTaP if indicated.106 Manufacturer recommends that Infanrix be used for the fourth dose of DTaP at 15 through 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.106 167

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 HepB 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 HepB vaccine also are indicated and there are no contraindications to any of the individual components.106 Data 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 HepB vaccine (monovalent or combination vaccine), Pediarix may be used to complete the 3-dose HepB vaccine series if doses of IPV and DTaP also are indicated and there are no contraindications to any of the individual components.106 Do not use for the initial dose of HepB vaccine that is indicated in neonates.97 106 Although a 3-dose series of Pediarix may be used in infants who received a dose of HepB vaccine at or shortly after birth,106 manufacturer states 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 those who previously received >1 dose of HepB vaccine.106

Children 4 through 6 Years of Age (DTaP-IPV; Kinrix)
IM

Each dose is 0.5 mL.167

May be used when immunization against diphtheria, tetanus, pertussis, and poliovirus is indicated in children 4 through 6 years of age.167

Used to provide the fifth dose of the DTaP vaccination series and the fourth dose of the IPV vaccination series in children 4 through 6 years of age receiving primary immunization with Infanrix (DTaP) and/or Pediarix (DTaP-HepB-IPV).167

Adults

Prevention of Poliomyelitis
Adults ≥19 Years of Age at Increased Risk of Exposure to Poliovirus (IPV; IPOL)
IM or Sub-Q

Each dose is 0.5 mL.1

Primary immunization in previously unvaccinated adults consists of a series of 3 doses.1 9 97 102

Give first dose on selected date; give second dose 1–2 months after first dose; give third dose 6–12 months after second dose.1 9 97 102 Alternatively, if there is insufficient time to follow recommended regimen, give 3 doses at least 4 weeks apart.1 9 97 102 If only 1–2 months are available, give 2 doses at least 4 weeks apart.1 9 97 102 If <1 month available, give a single dose to provide partial protection.1 9 97 102 152 If individual continues to be at increased risk, give remaining doses to complete the 3-dose primary vaccination series.97 102

Incompletely vaccinated adults: Give remaining doses to complete the 3-dose primary vaccination series.1 9 97

Adults who previously received a primary vaccination series of IPV or OPV and are at increased risk: Give a single dose of IPV as a supplemental (booster) dose.1 97 102 152 The need for more than 1 adult supplemental (booster) dose not established.9 102

Special Populations

Hepatic Impairment

No specific dosage recommendations.1

Renal Impairment

No specific dosage recommendations.1

Geriatric Patients

No specific dosage recommendations.1

Cautions for Poliovirus Vaccine Inactivated

Contraindications

  • IPV (IPOL)
  • Hypersensitivity to any ingredient in the vaccine (including phenoxyethanol, formaldehyde, neomycin, streptomycin, polymyxin B).1

  • Anaphylaxis or anaphylactic shock within 24 hours after a previous dose of IPV.1

  • Fixed-combination Vaccine Containing DTaP and IPV (DTaP-IPV; Kinrix,
  • Severe allergic reaction (e.g., anaphylaxis) to any ingredient in the vaccine (e.g., neomycin, polymyxin B) or after previous dose of any vaccine containing diphtheria, tetanus, pertussis, or poliovirus antigens.167

  • Encephalopathy (e.g., coma, decreased consciousness, prolonged seizures) within 7 days of a dose of pertussis-containing vaccine.106 167 168

  • Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy.167

  • Fixed-combination Vaccine Containing DTaP, HepB, and IPV (DTaP-HepB-IPV; Pediarix)
  • Severe allergic reaction (e.g., anaphylaxis) to any ingredient in the vaccine (e.g., yeast, neomycin, polymyxin B) or after previous dose of any vaccine containing diphtheria, tetanus, pertussis, hepatitis B, or poliovirus antigens.109

  • Encephalopathy (e.g., coma, decreased consciousness, prolonged seizures) within 7 days of a dose of pertussis-containing vaccine that is not attributed to another identifiable cause.106

  • Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy.106

  • Fixed-combination Vaccine Containing DTaP, IPV, and Hib (DTaP-IPV/Hib; Pentacel)
  • Severe allergic reaction (e.g., anaphylaxis) to any ingredient in the vaccine or after previous dose of the vaccine or any vaccine containing diphtheria, tetanus, pertussis, poliovirus, or Hib antigens.168

  • Encephalopathy (e.g., coma, decreased consciousness, prolonged seizures) within 7 days of a dose of pertussis-containing vaccine.168

  • Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy.168

Warnings/Precautions

Warnings

Guillain-Barré Syndrome

Guillain-Barré syndrome (GBS) has been temporally associated with administration of a previously available IPV formulation.1 Causal relationship to IPV not established.1

Mortality

Infant deaths have been temporally associated with administration of IPV.1 Causal relationship to IPV not established.1

Sensitivity Reactions

Hypersensitivity Reactions

Take 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.1 106 167 168

Epinephrine and other appropriate agents should be readily available in case an immediate allergic reaction occurs.1 106 167 168

Do not administer additional vaccine doses to individuals who developed anaphylaxis or anaphylactic shock temporally associated with a previous dose.1 106 167 168

Allergy to Neomycin or Other Anti-infectives

IPV (IPOL): Contains trace amounts of neomycin (<5 ng), streptomycin (<200 ng), and polymyxin B (<25 ng).1 Contraindicated in individuals who have experienced an anaphylactic reaction to neomycin, streptomycin, or polymyxin.1 97

DTaP-IPV (Kinrix): Contains trace amounts of neomycin (≤0.05 ng) and polymyxin B (≤0.01 ng).167 Manufacturer states the vaccine is contraindicated in individuals hypersensitive to neomycin and/or polymyxin B.167

DTaP-HepB-IPV (Pediarix): Contains trace amounts of neomycin (≤0.05 ng) and polymyxin B (≤0.01 ng).106 Manufacturer states the vaccine is contraindicated in individuals hypersensitive to neomycin and/or polymyxin B.106

DTaP-IPV/Hib (Pentacel): Contains trace amounts of neomycin (<4 pg) and polymyxin B (<4 pg).168

Neomycin allergy usually results in delayed-type (cell-mediated) hypersensitivity reactions manifested as contact dermatitis.97 101 ACIP and AAP state 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 delayed-type neomycin hypersensitivity if benefits of vaccination outweigh risks.97 101

Allergy to Certain Preservatives

IPV (IPOL): Contains trace amounts of phenoxyethanol (0.5%) and formaldehyde (0.02%).1 Manufacturer states the vaccine is contraindicated in individuals hypersensitive to these preservatives.1

DTaP-IPV (Kinrix): Contains residual formaldehyde (≤100 mcg) from the manufacturing process.167

DTaP-HepB-IPV (Pediarix): Contains residual formaldehyde (≤100 mcg) from the manufacturing process.106

DTaP-IPV/Hib (Pentacel): Contains trace amounts of phenoxyethanol (0.6%) and formaldehyde (≤ 5 mcg).168

Yeast Allergy

DTaP-HepB-IPV (Pediarix): Manufacturing process for hepatitis B vaccine component involves baker's yeast (Saccharomyces cerevisiae) and final product contains yeast protein (≤5%).106 Manufacturer states the vaccine is contraindicated in individuals hypersensitive to yeast.106

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;106 167 the vial stoppers are latex-free.106 167

Some individuals may be hypersensitive to natural latex proteins.101 106 167 Take appropriate precautions if one of these preparations is administered to individuals with a history of latex sensitivity.101 167

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.101

General Precautions

Individuals with Altered Immunocompetence

May be administered to individuals immunosuppressed as the result of disease or immunosuppressive therapy.1 101 102 103 151 168 169 Consider the possibility that the immune response to the vaccine may be reduced in these individuals.1 101 102 103 106 150 168 (See Specific Drugs under Interactions.)

Decreased titers to poliovirus types 1, 2, and/or 3 reported in previously immune transplant recipients.61 62 63 97 Consider IPV vaccination after stem cell transplant.97 (See Dosage and Administration.)

History of Previous Seizures

To reduce the possibility of postvaccination fever in infants or children with a history of previous seizures, an appropriate antipyretic may be given at the time of vaccination and for the next 24 hours.106 167 168

Concomitant Illness

Delay administration in individuals with acute febrile illness until symptoms have subsided.1 101 ACIP states that minor illness (with or without fever) generally does not preclude vaccination.101

Individuals with Bleeding Disorders

Because of the risk of hematoma in individuals with bleeding disorders and in those receiving anticoagulant therapy, ACIP recommends that IPV be given sub-Q when possible in these individuals.101

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.101 In these cases, use a fine needle (23 gauge) to administer the vaccine and apply firm pressure to the injection site (without rubbing) for ≥2 minutes.101 If patient is receiving therapy for hemophilia, administer the IM vaccine shortly after a scheduled dose of such therapy.101

Advise individual and/or their family about the risk of hematoma from IM injections.101

Use of Fixed Combinations

When the fixed-combination vaccine containing diphtheria, tetanus, pertussis, and poliovirus antigens (DTaP-IPV; Kinrix) is used, consider the cautions and precautions associated with each antigen.167

When the fixed-combination vaccine containing diphtheria, tetanus, pertussis, hepatitis B virus, and poliovirus antigens (DTaP-HepB-IPV; Pediarix) is used, consider the cautions and precautions associated with each antigen.106

When the combination vaccine containing diphtheria, tetanus, pertussis, poliovirus, and Hib antigens (DTaP-IPV/Hib; Pentacel) is used, consider the cautions and precautions associated with each antigen.168

Limitations of Vaccine Effectiveness

May not protect all vaccine recipients against poliomyelitis.1 168

To ensure optimal protection, the complete IPV vaccination series must be administered.101

Administration of 2 doses of IPV results in seroconversion and high antibody titers against poliovirus types 1, 2, and 3 in 95% of recipients; administration of 3 doses results in seroconversion in 99–100% of recipients.97

Duration of Immunity

Immunity is prolonged; immunity may be lifelong.97

Routine booster doses of IPV not recommended.1 A single supplemental (booster) dose of IPV can be considered in adults at increased risk of poliomyelitis.1 97 102 (See Adults under Dosage and Administration.)

Improper Storage and Handling

Improper storage or handling of vaccines may result in loss of vaccine potency and reduced immune response in vaccinees.101

Inspect all vaccines upon delivery and monitor during storage to ensure that the appropriate temperature is maintained.101

Do not administer IPV (IPOL) or combination vaccines containing IPV that have been mishandled or have not been stored at the recommended temperature.1 101 106 (See Storage under Stability.) If there are concerns about mishandling, contact the manufacturer or state or local health departments for guidance on whether the vaccine is usable.101

Specific Populations

Pregnancy

IPV (IPOL): Category C.1

Pregnant women generally do not need to be immunized against poliomyelitis unless they are at risk of imminent exposure to infection (e.g., traveling to areas of high risk).9 97 98 100 102

DTaP-IPV (Kinrix), DTaP-HepB-IPV (Pediarix), and DTaP-IPV/Hib (Pentacel) are not indicated for use in adults, including pregnant women.106 167 168

Lactation

IPV (IPOL): Not known whether antigens contained in IPV are distributed into milk.1 Use with caution in nursing women.1

Because inactivated vaccines do not multiply within the body, they should not pose any unusual problems for lactating women or their infants.9 97 101 CDC states that breast-feeding is not a contraindication for use of IPV in the infant or mother.102

Pediatric Use

IPV (IPOL): Safety and efficacy not established in children <6 weeks of age.1

DTaP-IPV (Kinrix): Safety and efficacy not established in children <4 years of age or in children ≥7 years of age.167

DTaP-HepB-IPV (Pediarix): Safety and efficacy 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 not established in infants <6 weeks of age or in children ≥7 years of age.106

DTaP-IPV/Hib (Pentacel): Safety and efficacy not established in infants <6 weeks of age or in children ≥5 years of age.168

Apnea has been reported following IM administration of vaccines in some infants born prematurely.106 Base decisions regarding when to administer an IM vaccine in infants born prematurely on consideration of the individual infant's medical status and potential benefits and possible risks of vaccination.106

Geriatric Use

DTaP-IPV (Kinrix), DTaP-HepB-IPV (Pediarix), and DTaP-IPV/Hib (Pentacel) are not indicated for use in adults, including geriatric adults.106 167 168

Common Adverse Effects

IPV (IPOL): Injection site reactions (tenderness, redness, swelling), irritability, fatigue, anorexia.1

DTaP-IPV (Kinrix): Injection site reactions (pain, redness, increase in arm circumference, swelling), drowsiness, fever, loss of appetite.167

DTaP-HepB-IPV (Pediarix): Injection site reactions (pain, redness, swelling), fever, drowsiness, fussiness/irritability, loss of appetite.106

DTaP-IPV/Hib (Pentacel): Injection site reactions (tenderness, redness, swelling, increased circumference of injected arm), fever, decreased activity/lethargy, inconsolable crying, fussiness/irritability.168

Interactions for Poliovirus Vaccine Inactivated

Other Vaccines

Although specific studies may not be available evaluating concurrent administration 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 97 101 Immunization with IPV can be integrated with immunization against diphtheria, tetanus, pertussis, Haemophilus influenzae type b (Hib), hepatitis A, hepatitis B, influenza, measles, mumps, rubella, rotavirus, meningococcal disease, pneumococcal disease, and varicella.97 101 145 However, unless commercially available 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.101 168

Specific Drugs

Drug

Interaction

Comments

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])

No evidence that immune globulin preparations interfere with immune response to IPV101

IPV may be given simultaneously with or at any interval before or after immune globulin preparations101

Immunosuppressive agents (e.g., alkylating agents, antimetabolites, corticosteroids, radiation)

Potential for decreased antibody response to vaccines101 167 168

If possible, avoid giving vaccines during chemotherapy or radiation101

If a vaccine dose is given during or within 2 weeks before immunosuppressive therapy is started, the vaccine dose should be repeated ≥3 months after immunosuppressive therapy is discontinued101

Vaccines generally should be administered 2 weeks prior to initiation of immunosuppressive therapy or deferred until ≥3 months after such therapy is discontinued101

Measles, mumps, and rubella vaccine (MMR)

Simultaneous administration of MMR vaccine and IPV does not interfere with the immune response or increase adverse effects of either vaccine97 101

IPV and MMR may be administered simultaneously (using different syringes and different injection sites)97 101

Rotavirus vaccine

Rotavirus vaccines (Rotarix, RotaTeq) have been administered concomitantly with IPV without a decrease in immune response to either vaccine176 177 178

Rotavirus vaccine may be administered concomitantly with or at any interval before or after IPV101

Vaccines, inactivated or toxoids

IPV does not affect immune response to diphtheria, tetanus, pertussis, Hib, or hepatitis B antigens1

May be administered concomitantly with or at any interval before or after inactivated vaccines or toxoids routinely used in infants and children101

Varicella vaccine

Simultaneous administration of varicella vaccine and IPV does not interfere with the immune response or increase adverse effects of either vaccine97 101

IPV and varicella vaccine may be administered simultaneously (using different syringes and different injection sites)97 101

Yellow fever vaccine

IPV may be given simultaneously (using different syringes and different injection sites) or at any interval before or after yellow fever vaccine101

Stability

Storage

Parenteral

For Injectable Suspension, for IM Use

DTaP-IPV/Hib (Pentacel): 2–8°C.168 Do not freeze; if freezing occurs, discard vaccine.168

Use immediately after reconstitution.168

Pentacel does not contain thimerosal or any other preservatives.168

Injectable Suspension, for IM or Sub-Q Use

IVP (IPOL): 2–8°C; do not freeze.1 165

IPOL does not contain thimerosal, but does contain 2-phenoxyethanol and formaldehyde as preservatives.1

Injectable Suspension, for IM Use

DTaP-IPV (Kinrix): 2–8°C.167 Do not freeze; if freezing occurs, discard vaccine.167

DTaP-HepB-IPV (Pediarix): 2–8°C.106 Do not freeze; if freezing occurs, discard vaccine.106

Kinrix and Pediarix do not contain thimerosal or any other preservatives.106 167

Actions

  • Poliovirus vaccine inactivated (IPV) contains poliovirus type 1 (Mahoney strain), type 2 (MEF-1 strain), and type 3 (Saukett strain) produced using monkey kidney cells (vero cells), purified, and inactivated with formalin.1

  • Commercially available as monovalent vaccine (IPOL).1 Also available as a fixed-combination vaccine containing diphtheria, tetanus, pertussis, and poliovirus antigens (DTaP-IPV; Kinrix), a fixed-combination vaccine containing diphtheria, tetanus, pertussis, hepatitis B, and poliovirus antigens (DTaP-HepB-IPV; Pediarix), and a kit that provides a combination vaccine containing diphtheria, tetanus, pertussis, poliovirus, and Hib antigens (DTaP-IPV/Hib; Pentacel).106 167 168

  • IPV stimulates active immunity to poliovirus infection by inducing production of highly specific antipoliovirus antibodies.1 2 44 64 93 117 129 The antibodies bind to antigenic sites on wild-type poliovirus and neutralize the virus, thus preventing it from spreading to the CNS.19 55 59 117

  • IPV is highly immunogenic.1 2 28 58 83 93 97 129 Essentially all healthy children (98–100%) develop protective antibodies following the recommended vaccination series.1 2 28 58 83 93 97 129 Over 90% of individuals ≥6 months of age develop protective antibodies after a single dose.124

Advice to Patients

  • Prior to administration of each vaccine dose, provide a copy of the appropriate CDC Vaccine Information Statement (VIS) to the patient or patient's legal representative as required by the National Childhood Vaccine Injury Act (VISs are available at ).1 106 163 167 168

  • Advise patient and/or patient's parent or guardian of the risks and benefits of vaccination with IPV.1 106 167 168

  • Importance of receiving the complete primary immunization series to ensure the highest level of protection, unless contraindicated.1 106 167 168

  • Importance of informing clinicians if any adverse reactions occur.1 106 167 168 Clinicians or individuals can report any adverse reactions that occur following vaccination to Vaccine Adverse Event Reporting System (VAERS) at 800-822-7967 or .106 168

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.1 106 167 168

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

  • Importance of informing patients of other important precautionary information.1 106 167 168 (See Cautions.)

Preparations

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

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 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

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions July 1, 2010. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

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

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