Ipol

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  • Vaccines
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Ipol Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Trivalent poliovirus vaccine; inactivated; whole virus grown in monkey kidney cells; IM or SC inj.

    Pharmacological Class

    IPV.

    How Supplied

    Multidose vial (10 doses)—1

    Storage

    • Store in the refrigerator at 2°C to 8°C (35°F to 46°F). Protect from light.

    Manufacturer

    Sanofi Pasteur, Inc.

    Mechanism of Action

    Poliomyelitis is caused by poliovirus Types 1, 2, or 3. Poliovirus Vaccine Inactivated induces the production of neutralizing antibodies against each type of virus which are related to protective efficacy.

    Ipol Indications

    Indications

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

    Ipol Dosage and Administration

    Adult

    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.

    Adult

    General Recommendations

    • Inject IM or SC in deltoid area. Each dose is 0.5mL.

    • Routine primary vaccination in adults ≥18yrs of age residing in the US: not recommended.

    • Unimmunized adults who are potentially exposed to wild poliovirus and have not been adequately immunized: 2 doses at a 1–2 month interval and a third dose 6–12 months later. 

    • Persons with previous wild poliovirus disease who are incompletely immunized or unimmunized should be given additional doses of Ipol vaccine if they fall into 1 or more of the following categories:

      • Travelers to regions or countries where poliomyelitis is endemic or epidemic. 

      • Healthcare workers in close contact with patients who may be excreting polioviruses. 

      • Laboratory workers handling specimens that may contain polioviruses. 

      • Members of communities or specific population groups with disease caused by wild polioviruses.

    Children

    <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.

    Children

    • Safety and efficacy have not been established in children less than 6 weeks of age.

    • Inject IM or SC in midlateral thigh for infants and small children and in deltoid area for older children. Each dose is 0.5mL.

    • Full IPV schedule: One dose at 2 months, 4 months, 6–18 months, and 4–6 years of age. Do not administer the vaccine more frequently than 4 weeks apart. The first dose may be administered as early as 6 weeks of age. Oral polio vaccine (OPV) is no longer available and is not recommended for routine immunization.

    • Incompletely vaccinated: review immunization status and consider supplemental immunization as follows for adults. Time intervals between doses longer than those recommended for routine primary immunization do not necessitate additional doses as long as a final total of four doses is reached.

    Ipol Contraindications

    Contraindications

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

    Ipol Boxed Warnings

    Not Applicable

    Ipol Warnings/Precautions

    Warnings/Precautions

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

    Pregnancy Considerations

    • It is not known whether Ipol vaccine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 

    • Only administer the Ipol vaccine to pregnant women if clearly needed.

    Nursing Mother Considerations

    • It is not known whether Ipol vaccine is excreted in human milk. 

    • Exercise caution when Ipol vaccine is administered to a nursing woman.

    Pediatric Considerations

    • Safety and effectiveness of Ipol vaccine in infants below 6 weeks of age have not been established.

    Ipol Pharmacokinetics

    See Literature

    Ipol Interactions

    Interactions

    Immunosuppressants: may get suboptimal response.

    Interactions

    • Ipol vaccine has no known interactions with drugs or foods.

    • Concomitant administration of other parenteral vaccines with separate syringes at separate sites is not contraindicated.

    • For the first 2 doses of Ipol: may administer at separate sites using separate syringes concomitantly with DTaP, acellular pertussis, Haemophilus influenzae type b (Hib), and hepatitis B vaccines. 

    • From historical data on the antibody responses to diphtheria, tetanus, whole-cell or acellular pertussis, Hib, or hepatitis B vaccines used concomitantly with IPOL vaccine, no interferences have been observed on the immunological endpoints accepted for clinical protection.

    • Immunosuppressants: may get suboptimal response.

    Ipol Adverse Reactions

    Adverse Reactions

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

    Adverse Reactions

    Body System as a Whole

    • Transient local reactions: erythema, induration, and pain.

    • Temperatures of ≥39°C (≥102°F).

    • Other symptoms included irritability, sleepiness, fussiness, anorexia, and crying.

    Digestive System

    • Anorexia and vomiting.

    Post-Marketing Experience

    • The following adverse events have been identified during post-approval use of Ipol vaccine. Because these events are reported voluntarily from a population of uncertain size, it may not be possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. 

      • Blood and lymphatic system disorders: lymphadenopathy 

      • General disorders and administration site conditions: agitation, injection site reaction including injection site rash and mass 

      • Immune system disorders: type I hypersensitivity including allergic reaction, anaphylactic reaction, and anaphylactic shock 

      • Musculoskeletal and connective tissue disorders: arthralgia, myalgia 

      • Nervous system disorders: convulsion, febrile convulsion, headache, paresthesia, somnolence, syncope 

      • Skin and subcutaneous tissue disorders: rash, urticaria 

    Ipol Clinical Trials

    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. 

     

    Ipol Note

    Not Applicable

    Ipol Patient Counseling

    See Literature

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