On Mar. 30, 1993, the Food and Drug Administration (FDA) approved a combined diphtheria and tetanus toxoids and whole-cell pertussis vaccine (DTP) and Haemophilus b conjugate vaccine. TETRAMUNE Trademark, available from Lederle-Praxis Biologicals (Pearl River, New York), combines two previously licensed products, DTP (TRIIMMUNOL Registered, manufactured by Lederle Laboratories {Pearl River, New York}) and Haemophilus b conjugate vaccine (HibTITER Registered, manufactured by Praxis Biologics, Inc. {Rochester, New York}).

This vaccine has been licensed for use in children aged 2 months-5 years for protection against diphtheria, tetanus, pertussis, and Hib disease when indications for vaccination with DTP vaccine and Haemophilus b conjugate vaccine coincide. Based on demonstration of comparable or higher antibody responses to each of the components of the two vaccines, TETRAMUNE Trademark is expected to provide protection against Hib, as well as diphtheria, tetanus, and pertussis, equivalent to that of already licensed formulations of other DTP and Haemophilus b vaccines.

The Advisory Committee for Immunization Practices (ACIP) recommends that all infants receive a primary series of one of the licensed Haemophilus b conjugate vaccines beginning at 2 months of age and a booster dose at age 12-15 months. The ACIP also recommends that all infants receive a four-dose primary series of diphtheria and tetanus toxoids and pertussis vaccine at 2, 4, 6, and 15-18 months of age, and a booster dose at 4-6 years.