ADVERSE REACTIONS AND ANTIBODY-RESPONSE TO 4 DOSES OF ACELLULAR OR WHOLE-CELL PERTUSSIS-VACCINE COMBINED WITH DIPHTHERIA AND TETANUS TOXOIDS IN THE FIRST 19 MONTHS OF LIFE

To assess the safety, immunogenicity, and lot consistency of a Jive-co mponent acellular pertussis vaccine combined with diphtheria and tetan us toxoid (Connaught Laboratories Limited), we randomly allocated 432 infants to receive one of three lots of an acellular pertussis vaccine or a single lot of whole cell pertussis vaccine. Infants were immuniz ed at 2, 4 and 6 months of age and between 17 and 19 months of age. Lo cal and systemic adverse reactions were reported significantly more fr equently by recipients of the whole cell than acellular vaccine after each dose. The antibody response against pertussis toxin, filamentous hemagglutinin, and 69 kDa protein was of greater magnitude in acellula r pertussis vaccine recipients than whole cell pertussis vaccine recip ients. Small differences were detected amongst the vaccine lots tested . We conclude that the acellular pertussis vaccine is safe and immunog enic for the first four doses in children under 2 years of age. Copyri ght (C) 1996 Elsevier Science Ltd.