Vaccines:

Indications for: IPOL

Poliomyelitis immunization (virus Types 1, 2, and 3).

Clinical Trials:

  • Poliovirus Vaccine Inactivated induces the production of neutralizing antibodies against each type of virus which are related to protective efficacy. Approval in the US was based upon demonstration of immunogenicity and safety in US children. 

    • 219 infants received 3 doses of a similar enhanced IPV at 2, 4, and 18 months of age manufactured by the same process as Ipol vaccine except the cell substrate for IPV was using primary monkey kidney cells. 

    • Seroconversion to all 3 types of poliovirus was demonstrated in 99% of these infants after 2 doses of vaccine given at 2 and 4 months of age. Following the third dose of vaccine at 18 months of age, neutralizing antibodies were present at a level of ≥1:10 in 99.1% of children to Type 1 and 100% of children to Types 2 and 3 polioviruses. 

  • In 3 US-clinical studies, Ipol vaccine was administered to more than 700 infants between 2 to 18 months of age using IPV only schedules and sequential IPV-OPV schedules. 

    • Seroprevalence rates for detectable serum neutralizing antibody (DA) at a ≥1:4 dilution were 95% to 100% (Type 1); 97% to 100% (Type 2) and 96% to 100% (Type 3) after two doses of IPOL vaccine depending on studies. 

  • In one study, the persistence of DA in infants receiving 2 doses of Ipol vaccine at 2 and 4 months of age was 91% to 100% (Type 1), 97% to 100% (Type 2), and 93% to 94% (Type 3) at twelve months of age. In another study, (12) 86% to 100% (Type 1), 95% to 100% (Type 2), and 82% to 94% (Type 3) of infants still had DA at 18 months of age.

  • In US trials and field studies conducted outside the US, Ipol vaccine, or a combination vaccine containing Ipol vaccine and DTP, was administered to more than 3,000 infants between 2 to 18 months of age using IPV only schedules and immunogenicity data are available from 1,485 infants.

    • After 2 doses of vaccine given during the first year of life, seroprevalence rates for detectable serum neutralizing antibody (neutralizing titer ≥1:4) were 88% to 100% (Type 1); 84% to 100% (Type 2) and 94% to 100% (Type 3) of infants, depending on studies. 

    • When 3 doses were given during the first year of life, post-dose 3 DA ranged between 93% to 100% (Type 1); 89% to 100% (Type 2) and 97% to 100% (Type 3) and reached 100% for Types 1, 2, and 3 after the fourth dose given during the second year of life (12 to 18 months of age). 

  • In infants immunized with three doses of an unlicensed combination vaccine containing Ipol vaccine and DTP given during the first year of life, and a fourth dose given during the second year of life, the persistence of detectable neutralizing antibodies was 96%, 96%, and 97% against poliovirus Types 1, 2, and 3, respectively, at six years of age. DA reached 100% for all types after a booster dose of Ipol vaccine combined with DTP vaccine. 

 

Adult Dosage:

Give by IM or SC inj in deltoid area. Each dose is 0.5mL. Routine primary vaccination in adults ≥18yrs of age residing in the US: not recommended. Previously unvaccinated with risk of exposure to poliovirus: 2 doses at a 1–2 month interval and a 3rd dose 6–12 months later. Incompletely vaccinated with risk of exposure to poliovirus: give at least 1 dose to complete series; may require additional doses to complete primary series. Completely vaccinated with risk of exposure to poliovirus: may give booster dose.

Children Dosage:

<6wks: not established. Give by IM or SC inj in midlateral thigh (for infants and small children) or deltoid area (for older children). Each dose is 0.5mL. Primary series: 3 doses ≥8wks apart usually given at 2mos, 4mos, and 6–18mos of age and a booster dose at 4–6yrs of age. Incompletely vaccinated: review immunization status and consider supplemental immunization as follows for adults. Oral polio vaccine (OPV) is no longer available and is not recommended for routine immunization.

IPOL Contraindications:

Hypersensitivity to formaldehyde, neomycin, streptomycin, or polymyxin B. May defer in acute febrile illness.

IPOL Warnings/Precautions:

Have epinephrine inj (1:1000) available. Immunodeficiency. Pregnancy. Nursing mothers.

IPOL Classification:

IPV.

IPOL Interactions:

Immunosuppressants: may get suboptimal response.

Adverse Reactions:

Local irritation, fever, sleepiness, fussiness, decreased appetite; syncope.

How Supplied:

Multidose vial (10 doses)—1