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Persons using assistive technology might not be able to fully access information in this file. For assistance, please send e-mail to: mmwrq@cdc.gov. Type 508 Accommodation and the title of the report in the subject line of e-mail. Notice to Readers FDA Approval of a Haemophilus b Conjugate Vaccine Combined by Reconstitution with an Acellular Pertussis VaccineOn 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:
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
* 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. Disclaimer All MMWR HTML versions of articles are electronic conversions from ASCII text into HTML. This conversion may have resulted in character translation or format errors in the HTML version. Users should not rely on this HTML document, but are referred to the electronic PDF version and/or the original MMWR paper copy for the official text, figures, and tables. An original paper copy of this issue can be obtained from the Superintendent of Documents, U.S. Government Printing Office (GPO), Washington, DC 20402-9371; telephone: (202) 512-1800. Contact GPO for current prices. **Questions or messages regarding errors in formatting should be addressed to mmwrq@cdc.gov.Page converted: 09/19/98 |
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