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Body System As A Whole
In earlier studies with the vaccine grown in primary monkey kidney cells, transient local reactions at the site of injection were observed.3 Erythema, induration and pain occurred in 3.2%, 1% and 13%, respectively, of vaccinees within 48 hours post-vaccination. Temperatures of ≥ 39°C ( ≥ 102°F) were reported in 38% of vaccinees. Other symptoms included irritability, sleepiness, fussiness, and crying. Because IPV was given in a different site but concurrently with Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed (DTP), these systemic reactions could not be attributed to a specific vaccine. However, these systemic reactions were comparable in frequency and severity to that reported for DTP given alone without IPV.12 Although no causal relationship has been established, deaths have occurred in temporal association after vaccination of infants with IPV.37
Four additional US studies using IPOL vaccine in more than 1,300 infants,12 between 2 to 18 months of age administered with DTP at the same time at separate sites or combined have demonstrated that local and systemic reactions were similar when DTP was given alone.
Table 212: Percentage of Infants Presenting
with Local or Systemic Reactions at 6, 24, and 48 Hours of Immunization with
IPOL Vaccine Administered Intramuscularly Concomitantly at Separate Sites with Sanofi¶
Whole-Cell DTP Vaccine at 2 and 4 Months of Age and with Sanofi Acellular
Pertussis Vaccine (Tripedia ) at 18 Months of Age
|REACTION||AGE AT IMMUNIZATION|
|6 Hrs.||24 Hrs.||48 Hrs.||6 Hrs.||24 Hrs.||48 Hrs.||6 Hrs.||24 Hrs.||48 Hrs.|
|Local, IPOL vaccine alone§|
|Erythema > 1”||0.50%||0.50%||0.50%||1.00%||0.00%||0.00%||1.40%||0.00%||0.00%|
|Fever > 102.2°F||1.00%||0.50%||0.50%||2.00%||0.50%||0.00%||0.00%||0.00%||4.20%|
|Persistent Crying||Percentage of infants within 72 hours after immunization was 0.0% after dose one, 1.4% after dose two, and 0.0% after dose three.|
|¶ Sanofi Pasteur Inc. formerly known as Aventis Pasteur Inc.
§ Data are from the IPOL vaccine administration site, given intramuscularly.
* The adverse reaction profile includes the concomitant use of Sanofi whole-cell DTP vaccine or Tripedia vaccine with IPOL vaccine. Rates are comparable in frequency and severity to that reported for whole-cell DTP given alone.
† Children who have been vaccinated with Tripedia 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
Reporting Of Adverse Events
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.
Read the Ipol (poliovirus vaccine inactivated) Side Effects Center for a complete guide to possible side effects
There are no known interactions of IPOL vaccine with drugs or foods. Concomitant administration of other parenteral vaccines, with separate syringes at separate sites, is not contraindicated. The first two doses of IPOL vaccine may be administered 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, acellular pertussis, Hib, or hepatitis B vaccines used concomitantly or in combination with IPOL vaccine, no interferences have been observed on the immunological end points accepted for clinical protection.11,16,36 (See DOSAGE AND ADMINISTRATION section.)
3. McBean AM, et al. Serologic response to oral polio vaccine and enhanced-potency inactivated polio vaccines. Am J Epidemiol 128: 615-628, 1988.
12. Unpublished data available from Sanofi Pasteur Inc.
28. ACIP. Poliomyelitis prevention in the United States: introduction of a sequential vaccination schedule of Inactivated Poliovirus Vaccine followed by Oral Poliovirus Vaccine. MMWR 46: No. RR-3, 1997.
37. Stratton, R. et al. Adverse Events Associated with Childhood Vaccines. Polio Vaccines. National Academy Press, 295-299, 1994.
38. CDC. Vaccine Adverse Event Reporting System - United States. MMWR 39: 730-733, 1990.
39. CDC. National Childhood Vaccine Injury Act. Requirements for permanent vaccination records and for reporting of selected events after vaccination. MMWR 37: 197-200, 1988.
40 Food & Drug Administration. New Reporting Requirements for Vaccine Adverse Events. FDA Drug Bull 18 (2), 16-18, 1988.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 11/30/2015
Additional Ipol Information
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