Anorexia and vomiting occurred with frequencies not significantly different as reported when DTP was given alone without IPV or OPV. (12)
Although no causal relationship between IPOL vaccine and GBS has been established, (28) GBS has been temporally related to administration of another inactivated poliovirus vaccine.
The following adverse events have been identified during postapproval 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. Adverse events were included based on one or more of the following factors: severity, frequency of reporting or strength of evidence for a causal relationship.
- 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, and somnolence
- Skin and subcutaneous tissue disorders: rash, urticaria
The National Vaccine Injury Compensation Program, established by the National Childhood Vaccine Injury Act of 1986, requires physicians and other healthcare providers who administer vaccines to maintain permanent vaccination records and to report occurrences of certain adverse events to the US Department of Health and Human Services. Reportable events include those listed in the Act for each vaccine and events specified in the package insert as contraindications to further doses of that vaccine. (38) (39) (40)
Reporting by parents or guardians of all adverse events after vaccine administration should be encouraged. Adverse events following immunization with vaccine should be reported by healthcare providers to the US Department of Health and Human Services (DHHS) Vaccine Adverse Event Reporting System (VAERS). Reporting forms and information about reporting requirements or completion of the form can be obtained from VAERS through a toll-free number 1-800-822-7967. (38) (39) (40)
Healthcare providers also should report these events to the Pharmacovigilance Department, Sanofi Pasteur Inc., Discovery Drive, Swiftwater, PA 18370 or call 1-800-822-2463.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The vial and its packaging should be inspected prior to use for evidence of leakage or a faulty seal. If evidence of such defects are observed, the vaccine should not be used. Do not remove the vial stopper or the metal seal holding it in place.
After preparation of the injection site, using a suitable sterile needle and aseptic technique, 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. IPOL should not be combined through reconstitution or mixed with any other vaccine.
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.
DO NOT ADMINISTER VACCINE INTRAVENOUSLY.
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.
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 0.5 mL doses given at a 1 to 2 month interval and a third 0.5 mL 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 0.5 mL doses of IPOL vaccine should be given at least 1 month apart. If less than 1 month is available, a single 0.5 mL 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 0.5 mL 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 0.5 mL dose of IPOL vaccine.
The preferred injection site of IPOL vaccine for adults is in the deltoid area.
NDC: 50090-1693-0 5 mL in a VIAL, MULTI-DOSE / 1 in a PACKAGE
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- Unpublished data available from Sanofi Pasteur SA.
- Unpublished data available from Sanofi Pasteur Inc.
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Product Information as of May 2020
Sanofi Pasteur SA
Marcy L’Etoile France
US Govt License #1724
Sanofi Pasteur Inc.
Swiftwater PA 18370 USA
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