Evaluation of a combined tetravalent diphtheria, tetanus, whole-cell pertussis and hepatitis B candidate vaccine administered to healthy infants according to a three-dose vaccination schedule.

A vaccine combining hepatitis B with diphtheria, tetanus and whole-cell Bordetella pertussis (DTPwHBV) would facilitate the attainment of universal vaccination of infants against hepatitis B. A candidate vaccine was administered to 42 infants beginning at 7-15 weeks of age. Antibodies were measured from pre- and postvaccination blood samples. After three doses, at least 94.9% of the infants were protected against hepatitis B, diphtheria and tetanus. Responses to B. pertussis were considered adequate. No serious adverse events were reported. These results indicate that this candidate vaccine is safe and immunogenic when administered to infants according to a three-dose schedule, with doses 2 months apart.