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^®*) combined by reconstitution with diphtheria and tetanus toxoids and acellular pertussis vaccine (DTaP) (Tripedia^®†) for use as the fourth dose in the childhood vaccination series. This combination vaccine will be sold under the trade name TriHIBit^TM. On July 31, 1996, Tripedia^® was licensed for the initial four doses of the diphtheria, tetanus, and pertussis vaccination series.¹ TriHIBit^TM 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