PEDIATRICS Vol. 92 No. 6 December 1993, pp. 827-832
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Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Pertussis and Haemophilus influenzae Type b Vaccine in Young Infants

Peter R. Paradiso PhD1, Deborah A. Hogerman 1, Dace Viceps Madore PhD1, Harry Keyserling MD2, James King MD3, Keith S. Reisinger MD4, Mark M. Blatter MD4, Edward Rothstein MD5, Henry H. Bernstein DO5, Pennridge Pediatric Associates5, and Jill Hackell MD6

1 From Lederle-Praxis Biologicals, West Henrietta, NY
2 From Emory University School of Medicine, Atlanta, GA
3 From University of Maryland, Baltimore
4 From Pittsburgh Pediatric Research, Upper St Clair, PA
5 From Pennridge Pediatrics, Sellersville, PA
6 From Lederle-Praxis Biologicals, Pearl River, NY.

Objective. To study the safety and immunogenicity of a combined diphtheria-tetanus-pertussis (DTP)-Haemophilus influenzae type b (HbOC) vaccine (TETRAMUNE) in infants as young as 2 months of age as compared to separate administration of DTP and HbOC.

Methods. Two-month-old infants were randomized to receive three doses 2 months apart of either DTP-HbOC as a single 0.5-mL injection or to receive 0.5 mL of DTP and HbOC concurrently in separate legs. Local and systemic adverse reactions were monitored within 72 hours of each immunization, and immunogenicity of each of the four vaccine components was measured.

Results. The incidence of both local and systemic adverse events following the tetravalent vaccine was similar to the incidence following separate vaccine administration. After three doses of vaccine, the response to each of the vaccine components was higher in the combined vaccine when compared to separate administration. In the case of the Haemophilus influenzae type b component, this enhancement was also seen after two doses. The response to the combined vaccine was consistent among the three lots tested as was the enhancement over separate administration.

Conclusions. The DTP-HbOC vaccine was safe and immunogenic in young infants and was generally more immunogenic than separate vaccination with DTP and HbOC. The use of such a combined vaccine reduces the number of injections given to young infants by half and is an important step toward improving vaccine delivery.

Key Words: Haemophilus influenzae type b vaccine • diphtheria-tetanus-pertussis vaccine • immunization

Submitted on December 4, 1992
Accepted on June 14, 1993




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