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Ipol

SIDE EFFECTS

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.3Erythema, 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 (poliovirus vaccine inactivated) 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 (poliovirus vaccine inactivated) 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 (TRIPEDIAR) AT 18 MONTHS OF AGE

REACTION AGE AT IMMUNIZATION
2 Months
(n=211)
4 Months
(n=206)
18 Months
(n=74)
6 Hrs. 24 Hrs. 48 Hrs. 6 Hrs. 24 Hrs. 48 Hrs. 6 Hrs. 24 Hrs. 48 Hrs.
Local, IPOL vaccinealone§
  Erythema > 1“ 0.5% 0.5% 0.5% 1.0% 0.0% 0.0% 1.4% 0.0% 0.0%
  Swelling 11.4% 5.7% 0.9% 11.2% 4.9% 1.9% 2.7% 0.0% 0.0%
  Tenderness 29.4% 8.5% 2.8% 22.8% 4.4% 1.0% 13.5% 4.1% 0.0%
Systemic*
  Fever> 102. 1.0% 0.5% 0.5% 2.0% 0.5% 0.0% 0.0% 0.0% 4.2%
  Irritability 64.5% 24.6% 17.5% 49.5% 25.7% 11.7% 14.7% 6.7% 8.0%
  Tiredness 60.7% 31.8% 7.1% 38.8% 18.4% 6.3% 9.3% 5.3% 4.0%
  Anorexia 16.6% 8.1% 4.3% 6.3% 4.4% 2.4% 2.7% 1.3% 2.7%
  Vomiting 1.9% 2.8% 2.8% 1.9% 1.5% 1.0% 1.3% 1.3% 0.0%
  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 (poliovirus vaccine inactivated) vaccine administration site, given intramuscularly.
* The adverse reaction profile includes the concomitant use of Sanofi whole-cell DTP vaccine or Tripedia vaccine with IPOL (poliovirus vaccine inactivated) 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.

Digestive System

Anorexia and vomiting occurred with frequencies not significantly different as reported when DTP was given alone without IPV or OPV.12

Nervous System

Although no causal relationship between IPOL (poliovirus vaccine inactivated) vaccine and GBS has been established,28 GBS has been temporally related to administration of another inactivated poliovirus vaccine.

Reporting of Adverse Events

The National Vaccine Injury Compensation Program, established by the National Childhood Vaccine Injury Act of 1986, requires physicians and other health-care 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 health-care 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

Health-care 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

DRUG INTERACTIONS

There are no known interactions of IPOL (poliovirus vaccine inactivated) 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 (poliovirus vaccine inactivated) 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 (poliovirus vaccine inactivated) vaccine, no interferences have been observed on the immunological end points accepted for clinical protection.11,16,36 (See DOSAGE AND ADMINISTRATION section.)

If IPOL (poliovirus vaccine inactivated) vaccine has been administered to persons receiving immunosuppressive therapy, an adequate immunologic response may not be obtained. (See PRECAUTIONS - General section.)

REFERENCES

3. McBean AM, et al. Serologic response to oral polio vaccine and enhanced-potency inactivated polio vaccines. Am J Epidemiol 128: 615-628, 1988

11. Unpublished data available from Sanofi Pasteur SA

16. Plotkin SA, et al. Inactivated polio vaccine for the United States: a missed vaccination opportunity. Pediatr Infect Dis J 14: 835839, 1995

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

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

Last reviewed on RxList: 2/20/2009
This monograph has been modified to include the generic and brand name in many instances.

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