IPOL vaccine is indicated for active immunization of infants (as young as 6 weeks of age), children and adults for the prevention of poliomyelitis caused by poliovirus Types 1, 2, and 3.²⁸

It is recommended that all infants (as young as 6 weeks of age), unimmunized children and adolescents not previously immunized be vaccinated routinely against paralytic poliomyelitis.²⁹ Following the eradication of poliomyelitis caused by wild poliovirus from the Western Hemisphere (including North and South America),³⁰ an IPV-only schedule was recommended to eliminate VAPP.⁷

All children should receive four doses of IPV at ages 2, 4, 6 to 18 months and 4 to 6 years. OPV is no longer available in the US and is not recommended for routine immunization.⁷ OPV is only recommended for special circumstances including the control of outbreaks.

Previous clinical poliomyelitis (usually due to only a single poliovirus type) or incomplete immunization with OPV are not contraindications to completing the primary series of immunization with IPOL vaccine.

Children of all ages should have their immunization status reviewed and be considered for 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 (see DOSAGE AND ADMINISTRATION section).

Routine primary poliovirus vaccination of adults (generally those 18 years of age or older) residing in the US is not recommended. Unimmunized adults who are potentially exposed to wild poliovirus and have not been adequately immunized should receive polio vaccination in accordance with the schedule given in the DOSAGE AND ADMINISTRATION section.²⁸

Persons with previous wild poliovirus disease who are incompletely immunized or unimmunized should be given additional doses of IPOL vaccine if they fall into one or more categories listed previously.

The following categories of adults are at an increased risk of exposure to wild polioviruses:^28,31

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

· Health-care 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.

IPOL vaccine should be used in all patients with immunodeficiency diseases and members of such patients´ households when vaccination of such persons is indicated. This includes patients with asymptomatic HIV infection, AIDS or AIDS-Related Complex, severe combined immunodeficiency, hypogammaglobulinemia, or agammaglobulinemia; altered immune states due to diseases such as leukemia, lymphoma, or generalized malignancy; or an immune system compromised by treatment with corticosteroids, alkylating drugs, antimetabolites or radiation. Immunogenicity of IPOL vaccine in individuals receiving immunoglobulin could be impaired and patients with an altered immune state may or may not develop a protective response against paralytic poliomyelitis after administration of IPV.³²

As with any vaccine, vaccination with IPOL vaccine may not protect 100% of susceptible individuals.

Use with other vaccines: refer to DOSAGE AND ADMINISTRATION section for this information.

Before administration, parenteral drug products should be checked visually for any deviation from normal appearance including container integrity. The syringe or vial and its packaging should be inspected prior to use for evidence of leakage, premature activation of the plunger, or a faulty tip seal. If evidence ofsuch defects are observed, the syringe should not be used.

After preparation of the injection site, immediately administer IPOL vaccine intramuscularly or subcutaneously. In infants and small children, the mid-lateral aspect of the thigh is the preferred site. In older children and adults, IPOL vaccine should be administered intramuscularly or subcutaneously in the deltoid area.

The syringe is intended for single use only, must not be reused, and must be disposed ofproperly and promptly following its use. To help avoid HIV (AIDS), HBV (Hepatitis), and other infectious diseases due to accidental needlesticks, contaminated needles should not be recapped or removed, unless there is no alternative or that such action is required by a specific medical procedure.

Care should be taken to avoid administering the injection into or near blood vessels and nerves. If blood or any suspicious discoloration appears in the syringe, do not inject but discard contents and repeat procedures using a new dose of vaccine administered at a different site.

The primary series of IPOL vaccine consists of three 0.5 mL doses administered intramuscularly or subcutaneously, preferably eight or more weeks apart and usually at ages 2, 4, and 6 to 18 months. Under no circumstances should the vaccine be given more frequently than four weeks apart. The first immunization may be administered as early as six weeks of age. For this series, a booster dose of IPOL vaccine is administered at 4 to 6 years of age.⁴¹

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 end points accepted for clinical protection.^11,16,36 (See DRUG INTERACTIONS section.) If the third dose of IPOL vaccine is given between 12 to 18 months of age, it may be desirable to administer this dose with Measles, Mumps, and Rubella (MMR) vaccine and/or other vaccines using separate syringes at separate sites,²⁸ but no data on the immunological interference between IPOL vaccine and these vaccines exist.

Children and adolescents with a previously incomplete series of polio vaccine should receive sufficient additional doses of IPOL vaccine to complete the series. OPV is no longer recommended for routine immunization and is recommended only in special circumstances⁷ (see General Recommendations section).

Interruption of the recommended schedule with a delay between doses does not interfere with the final immunity. There is no need to start the series over again, regardless of the time elapsed between doses.

The need to routinely administer additional doses is unknown at this time.²⁸

A primary series of IPOL vaccine is recommended for unvaccinated adults at increased risk of exposure to poliovirus. While the responses of adults to primary series have not been studied, the recommended schedule for adults is two doses given at a 1 to 2 month interval and a third dose given 6 to 12 months later. If less than 3 months but more than 2 months are available before protection is needed, three doses of IPOL vaccine should be given at least 1 month apart. Likewise, if only 1 or 2 months are available, two doses of IPOL vaccine should be given at least 1 month apart. If less than 1 month is available, a single dose of IPOL vaccine is recommended.²⁸

Adults who are at an increased risk of exposure to poliovirus and who have had at least one dose of OPV, fewer than three doses of conventional IPV or a combination of conventional IPV or OPV totaling fewer than three doses should receive at least one dose of IPOL vaccine. Additional doses needed to complete a primary series should be given if time permits.²⁸

Adults who are at an increased risk of exposure to poliovirus and who have previously completed a primary series with one or a combination of polio vaccines can be given a dose of IPOL vaccine.

The preferred injection site of IPOL vaccine for adults is in the deltoid area.

Syringe, without needle, 0.5 mL (10 per package — Product No. 49281-860-55

Vial, 10 Dose — Product No. 49281-860-10

CPTÒ Code: 90713

CPT is a registered trademark of the American Medical Association.

STORAGE

The vaccine is stable if stored in the refrigerator between 2° C and 8° C (35° F and 46° F). The vaccine must not be frozen.

REFERENCES

7. ACIP. Updated Recommendations of the Advisory Committee on Immunization Practices. Poliomyelitis Prevention in the United States. MMWR 49: No. RR-5, 2000

11. Unpublished data available from Aventis Pastuer SA

16. Plotkin SA, et al. Inactivated polio vaccine for the United States: a missed vaccination opportunity. Pediatr Infect Dis J 14: 835-839, 1995

28. ACIP. Poliomyelitis prevention in the United States: introduction ofa sequential vaccination schedule ofInactivated Poliovirus Vaccine followed by Oral Poliovirus Vaccine. MMWR 46: No. RR-3, 1997

29. WHO. Weekly Epidemiology Record 54: 82-83, 1979

30. Certification of poliomyelitis eradication — the Americas, 1994. MMWR 43: 720-722, 1994

31. Institute of Medicine. An evaluation of poliomyelitis vaccine poliomyelitis vaccine policy options. Washington, DC. National Academy of Sciences, 1988

32. ACIP. Immunization ofchildren infected with human T-lymphotropic virus type III/lymphadenopathy-associated virus. MMWR 35:595-606, 1986

36. Vidor E, et al. Fifteen-years experience with vero-produced enhanced potency inactivated poliovirus vaccine (eIPV). Ped Infect Dis J, 312-322, 1997

41. Recommended childhood immunization schedule — United States, 1999. MMWR 48: 12-16, 1999 Product information as of April 2005

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