Poliovirus Vaccine Inactivated (Monograph)

Brand name: IPOL
Drug class: Vaccines
ATC class: J07BF03
VA class: IM100

Poliovirus Vaccine Inactivated is also contained as an ingredient in the following combinations:
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined

Medically reviewed by Drugs.com on Feb 21, 2024. Written by ASHP.

Introduction

Inactivated virus vaccine.^{1 9 105 135 166} 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 9 105 135 166} Also commercially available in fixed-combination vaccines 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 and combination vaccine containing diphtheria, tetanus, pertussis, poliovirus, and Haemophilus influenza type b (Hib) antigens (DTaP-IPV/Hib; Pentacel).²²⁴ Other poliovirus vaccines (e.g., poliovirus vaccine live oral [OPV]; no longer commercially available in the US) may be available in other countries.^{9 105 115 164 166 182}

Uses for Poliovirus Vaccine Inactivated

Prevention of Poliomyelitis

Prevention of poliomyelitis caused by poliovirus types 1, 2, and 3 in infants and children 6 weeks through 17 years of age and in certain adults.^{1 9 105 166 199}

Poliomyelitis is an acute viral infection that involves the GI tract and occasionally the CNS.^{9 105} Polioviruses generally are transmitted by the fecal-oral and respiratory routes.^{1 9 44 57 105 129 169} Most poliovirus infections are asymptomatic;^{1 9 105 129 166} 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 and with complete recovery (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 and with complete recovery.^{105 166} In <2% of infections, there is rapid onset of asymmetric acute flaccid paralysis;^{1 105 129} residual paralytic disease occurs in about 66% of these patients.^{1 9 16 105} 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 95 129} Wild-type poliovirus infection has been eliminated in the US.^{9 17 19 41 43 44 86 91 93 95 105} Efforts are ongoing to eradicate poliomyelitis worldwide.^{9 115 182 183 184 186}

USPHS Advisory Committee on Immunization Practices (ACIP), AAP, and others recommend that all infants and children receive primary immunization against poliomyelitis initiated at 2 months of age.^{1 9 105 166 199} These experts also recommend catch-up vaccination for all children and adolescents ≤17 years of age who are unvaccinated or incompletely vaccinated against poliomyelitis.^{105 166 199}

For internationally adopted children whose immune status is uncertain, vaccinations can be repeated or serologic tests performed to confirm immunity.¹³⁴ For IPV, ACIP states that the simplest approach is to revaccinate those <18 years of age according to the recommended US immunization schedule.¹³⁴ (See Dosage and Administration.) Alternatively, serologic tests for specific antibody to poliovirus can be performed if available; repeat doses are unnecessary in those with protective titers against all 3 poliovirus types, but complete the age-appropriate IPV vaccination schedule.¹³⁴

ACIP and others do not recommend routine immunization against poliomyelitis in adults ≥18 years of age.^{1 9 105 166 200} However, IPV is recommended in unvaccinated adults at increased risk of exposure to poliovirus.^{1 9 105 115 166} 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, and laboratory personnel handling specimens that may contain polioviruses.^{1 9 105 115 115 166} 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.^{1 105 134 151 155 156} The possibility that the vaccine may be less immunogenic in immunocompromised individuals should be considered.^{1 105 106 134 224} (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.^{106 221 223 224} Use of a combination vaccine generally is preferred over separate injections of the equivalent component vaccines;^{105 134 199} 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.¹³⁴

DTaP-IPV (Kinrix): Can be used in children 4 through 6 years of age to provide fifth dose of DTaP vaccination series and fourth dose of IPV vaccination series in those receiving primary immunization with Infanrix (DTaP) and/or Pediarix (DTaP-HepB-IPV) when there are no contraindications to any of the individual components.²²³

DTaP-IPV (Quadracel): Can be used in children 4 through 6 years of age to provide fifth dose of DTaP vaccination series and fourth or fifth dose of IPV vaccination series in those receiving primary immunization with Pentacel (DTaP-IPV/Hib) and/or Daptacel (DTaP).^{221 222}

DTaP-HepB-IPV (Pediarix): Can be used as 3-dose primary series in infants and children 6 weeks through 6 years of age born to HBsAg-negative women when doses of DTaP, HepB, and IPV are indicated and there are no contraindications to any of the individual components.¹⁰⁶ ACIP states also may be used to complete HepB vaccination series in infants 6 weeks through 6 years of age born to HBsAg-positive women^{† [off-label]}.²⁰⁸ Should not be used for initial HepB dose indicated in neonates.^{105 106} For prevention of poliomyelitis in infants and children 6 weeks through 6 years of age, may be used for initial 3 doses in IPV series or may be used to complete first 3 doses of IPV series in those who have received 1 or 2 doses of another IPV vaccine.¹⁰⁶

DTaP-IPV/Hib (Pentacel): Can be used as 4-dose series in infants and children 6 weeks through 4 years of age when doses of DTaP, IPV, and Hib vaccine are indicated and there are no contraindications to any of the individual components.^{173 224} 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,^{173 224} data are not available on safety and immunogenicity in such infants and children.²²⁴

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

Poliovirus Vaccine Inactivated Dosage and Administration

Administration

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

DTaP-IPV (Kinrix, Quadracel), DTaP-HepB-IPV (Pediarix), DTaP-IPV/Hib (Pentacel): Administer by IM injection.^{106 221 223 224} Do not administer sub-Q, IV, or intradermally.^{106 221 223 224}

Syncope (vasovagal or vasodepressor reaction; fainting) may occur following vaccination;^{106 134 223} may be accompanied by transient neurologic signs (e.g., visual disturbance, paresthesia, tonic-clonic limb movements).^{106 223} Occurs most frequently in adolescents and young adults.¹³⁴ Have procedures in place to avoid falling injury and 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, observe patient until symptoms resolve.¹³⁴

May be given simultaneously with other age-appropriate vaccines.^{134 173 223 224} (See Interactions.)

When multiple vaccines are administered during a single health-care visit, give each parenteral vaccine with a different syringe and at different injection sites.¹³⁴ Separate injection sites by at least 1 inch (if anatomically feasible) to allow appropriate attribution of any local adverse effects that may occur.¹³⁴

IPV (IPOL)

Shake vaccine well immediately prior to IM or sub-Q administration; should appear clear and colorless.¹

Do not mix with any other vaccine or solution.¹³⁴

IM Injection

Depending on patient age, administer IM into anterolateral muscles of thigh or deltoid muscle.^{1 134 224} In infants and children 6 weeks through 2 years of age, anterolateral thigh is preferred;^{1 134} alternatively, 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, deltoid muscle preferred.^{1 134 221}

Avoid administering into gluteal area or areas where there may be a major nerve trunk.¹³⁴ If gluteal muscle is chosen for infants <12 months of age because of special circumstances (e.g., physical obstruction of other sites), it is essential that clinician identify anatomical landmarks prior to injection.¹³⁴

To ensure delivery into muscle, make IM injections 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 injection site, and injection technique.¹³⁴

Sub-Q Injection

Make sub-Q injections into upper-outer triceps area or anterolateral thigh.¹³⁴ In infants <1 year of age, anterolateral thigh preferred.¹³⁴

To ensure appropriate delivery, administer sub-Q injections at a 45° angle using a 5/8 inch, 23- to 25-gauge needle.¹³⁴

Combination Vaccines Containing IPV and Other Antigens

Administer DTaP-IPV (Kinrix, Quadracel), DTaP-HepB-IPV (Pediarix), and DTaP-IPV/Hib (Pentacel) by IM injection.^{106 221 223 224}

Depending on patient age, administer IM into anterolateral muscles of thigh or deltoid muscle.^{106 134 221 223 224} In infants and children 6 weeks through 2 years of age, anterolateral thigh is preferred;^{106 134 224} alternatively, 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, deltoid muscle preferred.^{134 221 223}

Avoid administering into gluteal area or areas where there may be a major nerve trunk.¹³⁴ If gluteal muscle is chosen for infants <12 months of age because of special circumstances (e.g., physical obstruction of other sites), it is essential that clinician identify anatomical landmarks prior to injection.¹³⁴

To ensure delivery into muscle, make IM injections 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.^{106 134 171 172}

DTaP-IPV (Kinrix)

Do not mix with any other vaccine.²²³

Shake vial or prefilled syringe vigorously immediately prior to use.²²³ Should appear as a uniform, turbid, white suspension after shaking;²²³ discard if it contains particulate matter, is discolored, or cannot be resuspended.²²³

DTaP-IPV (Quadracel)

Do not mix with any other vaccine.²²¹

Shake single-dose vial well immediately prior to use.²²¹ Should appear as a uniform, white, cloudy suspension after shaking;²²¹ discard if it contains particulate matter, is discolored, or cannot be resuspended.²²¹

DTaP-HepB-IPV (Pediarix)

Do not mix with any other vaccine.¹⁰⁶

Shake prefilled syringe vigorously immediately prior to use.¹⁰⁶ Should appear as a uniform, turbid, white suspension after shaking;¹⁰⁶ discard if it contains particulate matter, is discolored, or cannot be resuspended.¹⁰⁶

DTaP-IPV/Hib (Pentacel)

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

Reconstitute single-dose vial of lyophilized ActHIB vaccine by adding entire contents of single-dose vial of DTaP-IPV vaccine according to manufacturer's instructions to provide a combined preparation containing diphtheria, tetanus, pertussis, poliovirus, and Hib antigens.²²⁴ Gently swirl until a cloudy, uniform white to off-white (yellow tinge) suspension is obtained.²²⁴

Administer immediately after reconstitution.²²⁴

Do not mix any component of DTaP-IPV/Hib (Pentacel) with any other vaccine or solution.²²⁴

Dosage

Dosing schedule varies according to the individual's age and immunization status.^{1 9 105 199}

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

Medically stable preterm and low-birthweight infants generally should be vaccinated at the usual chronologic age using usual dosage.^{105 134} (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 vaccination series over.^{1 105 134 199}

Pediatric Patients

Prevention of Poliomyelitis

Infants and Children 6 Weeks through 6 Years of Age (IPV; IPOL)

Each dose is 0.5 mL.¹

Primary immunization consists of a series of 4 doses.^{1 9 105 179 199}

ACIP, AAP, and others recommend that IPV doses be given at 2, 4, 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, give a booster dose as soon as feasible.¹⁷⁹

Initial 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 and at least 6 months after the previous dose.^{105 199}

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.^{105 179 199} 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)^{179 199} since lower seroconversion rates may occur.¹⁷⁹

Children and Adolescents 7 through 17 Years of Age (IPV; IPOL)

Each dose is 0.5 mL.¹

Primary immunization or catch-up vaccination consists of a series of 4 doses.^{1 9 105 199}

Incompletely vaccinated individuals: Give remaining doses to complete the 4-dose primary vaccination series.^{1 9 105} Fourth dose not necessary in those who received third dose at ≥4 years of age and at least 6 months after previous dose.¹⁹⁹

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

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.^{105 179 199}

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

Each dose is 0.5 mL.²²⁴

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 infants and children 6 weeks through 4 years of age, Pentacel is given in a series of 4 doses.²²⁴ Give doses at 2, 4, 6, and 15 through 18 months of age.²²⁴ Initial dose usually 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, give an additional booster dose of age-appropriate vaccine containing IPV (IPOL or Kinrix) 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, give a fifth dose of DTaP (Daptacel) 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 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 vaccination series if doses of DTaP and Hib vaccine also are indicated and there are no contraindications to any of the individual components.^{173 224}

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 vaccination series if doses of IPV and Hib vaccine also are indicated and there are no contraindications to any of the individual components.^{173 224}

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 vaccination series when doses of IPV and DTaP 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

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

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^{† [off-label]}.²⁰⁸

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.^{106 199}

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.^{106 223}

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 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.^{105 106} 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, Quadracel)

Each dose is 0.5 mL.^{221 223}

May be used when immunization against diphtheria, tetanus, pertussis, and poliovirus is indicated in children 4 through 6 years of age.^{221 223}

Kinrix: Used to provide fifth dose of DTaP vaccination series and fourth dose of IPV vaccination series in children 4 through 6 years of age receiving primary immunization with Infanrix (DTaP) and/or Pediarix (DTaP-HepB-IPV).²²³

Quadracel: Used to provide fifth dose of DTaP vaccination series and fourth or fifth dose of IPV vaccination series in those receiving primary immunization with Pentacel (DTaP-IPV/Hib) and/or Daptacel (DTaP).^{221 222}

Adults

Prevention of Poliomyelitis

Adults ≥18 Years of Age at Increased Risk of Exposure to Poliovirus (IPV; IPOL)

Each dose is 0.5 mL.¹

Primary immunization in previously unvaccinated adults consists of a series of 3 doses.^{1 9 105 166}

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 9 105 166} Alternatively, if there is insufficient time to follow recommended regimen, give 3 doses at least 4 weeks apart.^{1 9 105 166} If only 1–2 months are available, give 2 doses at least 4 weeks apart.^{1 9 105 166} If <1 month available, give a single dose to provide partial protection.^{1 9 105 166}

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

Adults who previously received a primary vaccination series of IPV or OPV or a combination of IPV and OPV in childhood and are at increased risk: Give a supplemental (booster) dose of IPV.^{1 9 105 115 166 235} The need for more than a single lifetime booster dose not established.^{9 105 115 166 235}

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

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.²²³

• Encephalopathy (e.g., coma, decreased consciousness, prolonged seizures) within 7 days of a dose of pertussis-containing vaccine that is not attributable to another identifiable cause.²²³

• Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy.²²³

DTaP-IPV (Quadracel)

• 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.²²¹

• Encephalopathy (e.g., coma, decreased consciousness, prolonged seizures) within 7 days of a dose of pertussis-containing vaccine that is not attributable to another identifiable cause.²²¹

• Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy.²²¹

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.¹⁰⁶

• 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

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.²²⁴

• Encephalopathy (e.g., coma, decreased consciousness, prolonged seizures) within 7 days of a dose of pertussis-containing vaccine.²²⁴

• Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy.²²⁴

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

Postmarketing reports of hypersensitivity reactions, including anaphylactic reaction and anaphylactic shock, following administration of IPV.¹ Rash and urticaria also reported.¹

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.^{1 106 223 224}

Epinephrine and other appropriate agents should be readily available in case an immediate allergic reaction occurs.^{1 106 221 223 224}

Do not administer additional vaccine doses to individuals who developed anaphylaxis or anaphylactic shock temporally associated with a previous dose.^{1 106 223 224}

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

DTaP-IPV (Kinrix): Contains trace amounts of neomycin (≤0.05 ng) and polymyxin B (≤0.01 ng).²²³ Manufacturer states the vaccine is contraindicated in individuals with severe hypersensitive (e.g., anaphylaxis) to neomycin and/or polymyxin B.²²³

DTaP-IPV (Quadracel): Contains trace amounts of neomycin (<4 pg) and polymyxin B (<4 pg).²²¹

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 with severe hypersensitivity (e.g., anaphylaxis) to neomycin and/or polymyxin B.¹⁰⁶

DTaP-IPV/Hib (Pentacel): Contains trace amounts of neomycin (<4 pg) and polymyxin B (<4 pg).²²⁴

Neomycin allergy usually results in delayed-type (cell-mediated) hypersensitivity reactions manifested as contact dermatitis.^{105 134} 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.^{105 134}

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.²²³

DTaP-IPV (Quadracel): Contains phenoxyethanol (0.6%) and residual formaldehyde (≤5 mcg) from the manufacturing process.²²¹

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).²²⁴

Yeast Allergy

DTaP-HepB-IPV (Pediarix): Manufacturing process for HepB 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 caps) of single-dose prefilled syringes of DTaP-IPV (Kinrix) and DTaP-HepB-IPV (Pediarix) may contain natural rubber latex;^{106 223} vial stoppers are latex-free.^{106 223}

Some individuals may be hypersensitive to natural latex proteins.^{106 134 223} Take appropriate precautions if one of these preparations 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 risk of a potential allergic reaction.¹³⁴ Contact-type allergy is the most common type of latex sensitivity.¹³⁴

General Precautions

Individuals with Altered Immunocompetence

May be administered to individuals immunosuppressed as the result of disease or immunosuppressive therapy,^{1 134 155 156 224} but consider possibility that the immune response to the vaccine and efficacy may be reduced in these individuals.^{1 105 106 134 221 223 224} (See Specific Drugs under Interactions.)

Recommendations regarding use of IPV or combination vaccines containing IPV in HIV-infected adults, adolescents, and children are the same as those for individuals who are not HIV infected.^{105 134 155 156} Consider possibility that immunization may be less effective in HIV-infected individuals than in immunocompetent individuals.^{105 134}

Decreased titers to poliovirus types 1, 2, and/or 3 reported in previously immune transplant recipients.^{61 62 63 105} Revaccination with inactivated vaccines (e.g., IPV) should generally be initiated 6 months after autologous or allogeneic hematopoietic stem cell transplant.¹³⁴

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.^{106 223 224}

Concomitant Illness

A decision to administer or delay vaccination in an individual with a current or recent febrile illness depends on the severity of symptoms and etiology of the illness.^{1 134}

Minor acute illness, such as mild diarrhea or mild upper respiratory tract infection (with or without fever), generally does not preclude vaccination, but defer vaccination in individuals with moderate or severe acute illness (with or without fever).^{105 134}

Limitations of Vaccine Effectiveness

May not protect all vaccine recipients against poliomyelitis.^{1 221 224}

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

Duration of Immunity

Duration of immunity following primary immunization with IPV not known,^{115 166} but probably is prolonged and may be lifelong.^{105 115 166}

Routine booster doses of IPV not recommended.¹ A single supplemental (booster) dose of IPV recommended in certain adults at increased risk of poliomyelitis.^{1 9 105 115 235} (See Adults under Dosage and Administration.)

Use of Fixed Combinations

When fixed-combination vaccine containing diphtheria, tetanus, pertussis, and poliovirus antigens (DTaP-IPV; Kinrix, Quadracel) used, consider cautions, precautions, and contraindications associated with each antigen.^{221 223}

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

When combination vaccine containing diphtheria, tetanus, pertussis, poliovirus, and Hib antigens (DTaP-IPV/Hib; Pentacel) used, consider cautions, precautions, and contraindications associated with each antigen.²²⁴

Improper Storage and Handling

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

Inspect all vaccines upon delivery and monitor during storage to ensure that the appropriate temperature is maintained.¹³⁴ (See Storage under Stability.)

Do not administer IPV (IPOL) or combination vaccines containing IPV that have been mishandled or have not been stored at the recommended temperature.^{1 106 134}

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

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).^{9 105 115}

DTaP-IPV (Kinrix, Quadracel), DTaP-HepB-IPV (Pediarix), and DTaP-IPV/Hib (Pentacel): Category C.^{106 221 223 224} Not indicated in adults, including pregnant women.^{106 221 223 224}

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.^{9 105 134} CDC states that breast-feeding is not a contraindication for use of IPV in the infant or mother.¹¹⁵

Pediatric Use

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

DTaP-IPV (Kinrix, Quadracel): Safety and efficacy not established in children <4 years of age or in children ≥7 years of age.^{221 223}

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 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.²²⁴

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

Geriatric Use

DTaP-IPV (Kinrix, Quadracel), DTaP-HepB-IPV (Pediarix), and DTaP-IPV/Hib (Pentacel): Not indicated in adults, including geriatric adults.^{106 221 223 224}

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.²²³

DTaP-IPV (Quadracel): Injection site reactions (pain, redness, increase in arm circumference, swelling), myalgia, malaise, headache.²²¹

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.²²⁴

Drug Interactions

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.^{1 105 134} 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.^{105 134 199} 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.^{134 224}

Specific Drugs

Stability

Storage

Parenteral

Injectable Suspension, for IM or Sub-Q Use

IPV (IPOL): 2–8°C; do not freeze.¹

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

Injectable Suspension, for IM Use

DTaP-IPV (Kinrix, Quadracel): 2–8°C.^{221 223} Do not freeze; discard if freezing occurs.^{221 223}

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

Kinrix, Quadracel, Pediarix: Do not contain thimerosal or any other preservatives.^{106 221 223}

For Injectable Suspension, for IM Use

DTaP-IPV/Hib (Pentacel): 2–8°C.²²⁴ Do not freeze; discard if freezing occurs.²²⁴

Use immediately after reconstitution.²²⁴

Does not contain thimerosal or any other preservatives.²²⁴

Actions

• 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

• IPV also available as fixed-combination vaccines containing diphtheria, tetanus, pertussis, and poliovirus antigens (DTaP-IPV; Kinrix, Quadracel), 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).^{106 221 223 224}

• 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 93 105 129} Essentially all healthy children (98–100%) develop protective antibodies following the recommended vaccination series.^{1 2 28 58 83 93 105 129} 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 [Web]).^{1 106 162 163 223 224}

• Advise patient and/or patient's parent or guardian of the risks and benefits of vaccination with IPV.^{1 106 223 224}

• Importance of receiving the complete primary immunization series to ensure the highest level of protection, unless contraindicated.^{1 106 223 224}

• Importance of informing clinicians if any adverse reactions occur.^{1 106 223 224} Clinicians or individuals can report any adverse reactions that occur following vaccination to Vaccine Adverse Event Reporting System (VAERS) at 800-822-7967 or [Web].^{106 224}

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.^{1 106 223 224}

• 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.^{1 106 223 224} (See Cautions.)

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.

Medical Disclaimer