COMPARISON OF 13 ACELLULAR PERTUSSIS VACCINES - ADVERSE REACTIONS

Objective. To compare the reactogenicity of a licensed conventional wh ole-cell (WCL) and 13 acellular pertussis vaccines that differed in th e source, manufacture, and quantity of included antigens; all vaccines included diphtheria and tetanus toxoids. Methods. Healthy infants wer e enrolled through six university-based vaccine and treatment evaluati on units and were randomized to receive one of the study vaccines at 2 , 4, and 6 months of age. Parents recorded the occurrence of fever, re dness, swelling, pain, fussiness, drowsiness, anorexia, and use of ant ipyretics for 2 weeks after each inoculation; nurses interviewed paren ts on the third day and at each succeeding visit; long-term follow-up information was collected from parents and medical records 1 year afte r the third immunization. Results. Of 2200 vaccinated infants, 2189 co ntributed reaction data after 6375 vaccinations. For every acellular v accine, every monitored reaction except vomiting occurred at a signifi cantly lower frequency and severity than was seen with WCL. The groups receiving acellular pertussis vaccines differed significantly with re spect to redness, swelling, pain, and vomiting, but not with respect t o fussiness, antipyretic use, drowsiness, or anorexia.