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
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 9
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