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Notice to Readers FDA Approval of a Haemophilus b Conjugate Vaccine Combined by Reconstitution with an Acellular Pertussis Vaccine

On September 27, 1996, the Food and Drug Administration (FDA) licensed a Haemophilus b Conjugate Vaccine (ActHIB{Registered} * ) combined by reconstitution with diphtheria and tetanus toxoids and acellular pertussis vaccine (DTaP) (Tripedia{Registered} ** ) for use as the fourth dose in the childhood vaccination series. This combination vaccine will be sold under the trade name TriHIBit{Trademark}. On July 31, 1996, Tripedia{Registered} was licensed for the initial four doses of the diphtheria, tetanus, and pertussis vaccination series (1). TriHIBit{Trademark} is the first vaccine to be licensed in the United States that combines DTaP with a Haemophilus b Conjugate Vaccine.

The Advisory Committee on Immunization Practices (ACIP), the Committee on Infectious Diseases of the American Academy of Pediatrics, and the American Academy of Family Physicians recommend that children routinely receive a series of five doses of vaccine against diphtheria, tetanus, and pertussis before age 7 years and four doses of vaccine against Haemophilus influenzae type b (Hib) disease before age 2 years (2-7). The first four doses of the diphtheria, tetanus, and pertussis vaccination series should be administered at ages 2, 4, 6, and 15-18 months and the fifth dose at age 4-6 years. If diphtheria, tetanus, and whole-cell pertussis vaccine (DTP) is used as a fourth dose, it may be administered as early as 12 months of age provided that 6 months have elapsed since the third dose.

The following evidence supports the use of TriHIBit{Trademark} for the fourth dose of the diphtheria, tetanus, pertussis, and Hib vaccination series:

  1. In clinical studies, children aged 15-20 months who previously had received three doses of Haemophilus b Conjugate Vaccine and DTP were administered either Tripedia{Registered} and ActHIB{Registered} vaccines at separate sites or combined as a single injection. In both groups, following administration of the fourth dose, 100% of children had serologic evidence of long-term protection from invasive Hib disease, diphtheria, and tetanus (Connaught Laboratories, Inc., unpublished data). The proportions of children who had at least fourfold antibody responses to pertussis toxin measured by enzyme-linked immunosorbent assay or Chinese hamster ovary cell assay were greater than or equal to 85% in both groups; a smaller proportion of children who had received the combined vaccine had at least fourfold antibody response to filamentous hemagglutinin, but the clinical importance of this difference is not known.

  2. The rates of local reactions, fever, and other common systemic symptoms following receipt of Tripedia{Registered} inoculations were lower than those following DTP vaccination for each of the first four doses in the series (5,8; Connaught Laboratories, Inc., unpublished data). In randomized trials, the local reactions were mild following administration of TriHIBit{Trademark} as a fourth dose as a single injection or ActHIB{Registered} simultaneously with Tripedia{Registered} as two injections at separate sites. Rates of both local and systemic reactions were similar between children who had received vaccines combined or separate (Connaught Laboratories, Inc., unpublished data).

  3. Protective efficacy of TriHIBit{Trademark} when used as a fourth dose in the childhood vaccination series has not been evaluated in a clinical trial. This vaccine has been licensed for use as the fourth dose on the basis of seroconversion and safety data.

Because of the reduced frequency of adverse reactions and high efficacy, ACIP recommends DTaP for routine use for all doses of the pertussis vaccination series (1). TriHIBit{Trademark} can be administered as the fourth dose of the vaccination series at age 15-18 months following administration of either DTaP or DTP. TriHIBit{Trademark} has not been licensed for use as the first three doses of the vaccination series. Vaccine should be used immediately (within 30 minutes) after reconstitution. A complete ACIP statement providing recommendations for use of DTaP and DTaP combined with Haemophilus b Conjugate Vaccine is being developed.

References

  1. CDC. Food and Drug Administration approval of an acellular pertussis vaccine for the initial four doses of the diphtheria, tetanus, and pertussis vaccination series. MMWR 1996;45:676-7.

  2. CDC. Diphtheria, tetanus, and pertussis: recommendations for vaccine use and other preventive measures: recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 1991;40(no. RR-10).

  3. American Academy of Pediatrics. Report of the Committee on Infectious Diseases. Elk Grove Village, Illinois: American Academy of Pediatrics, Committee on Infectious Diseases, 1991.

  4. CDC. Pertussis vaccination: acellular pertussis vaccine for reinforcing and booster use -- supplementary ACIP statement: recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 1992;41(no. RR-1).

  5. CDC. Pertussis vaccination: acellular pertussis vaccine for the fourth and fifth doses of the DTP series: update to the supplementary ACIP statement: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 1992;41(no. RR-15).

  6. CDC. Haemophilus b conjugate vaccines for prevention of Haemophilus influenzae type b disease among infants and children two months of age and older: recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 1991;40(no. RR-1).

  7. CDC. Recommendations for use of Haemophilus b conjugate vaccines and a combined diphtheria, tetanus, pertussis, and Haemophilus b vaccine: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 1993;42(no. RR-13).

  8. Decker MD, Edwards KM, Steinhoff MC, et al. Comparison of 13 acellular pertussis vaccines: adverse reactions. Pediatrics 1995;96(suppl):557-66.

* Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) is manufactured by Pasteur Merieux Serums & Vaccines S.A. ActHIB is identical to Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) -- OmniHIB (distributed by SmithKline Beecham Pharmaceuticals). Use of trade names and commercial sources is for identification only and does not imply endorsement by the Public Health Service or the U.S. Department of Health and Human Services. 

** Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, prepared and distributed as Tripedia{Registered} by Connaught Laboratories, Inc. (Swiftwater, Pennsylvania), was licensed July 31, 1996, for use in infants. The purified acellular pertussis vaccine component is produced by BIKEN/Tanabe Corporation (Osaka, Japan) and is combined with diphtheria and tetanus toxoids manufactured by Connaught Laboratories, Inc.




Use of trade names and commercial sources is for identification only and does not imply endorsement by the U.S. Department of Health and Human Services.

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