PEDIATRICS Vol. 96 No. 3 September 1995, pp. 557-566
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Comparison of 13 Acellular Pertussis Vaccines: Adverse Reactions

Michael D. Decker MD, MPH1, Kathryn M. Edwards MD2, Mark C. Steinhoff MD3, Margaret B. Rennels MD4, Michael E. Pichichero MD5, Janet A. Englund MD6, Edwin L. Anderson MD7, Maria A. Deloria BS8, and George F. Reed PhD8

1 Departments of Preventive Medicine, Medicine (Infectious Diseases), Vanderbilt University School of Medicine, Nashville, TN
2 Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN
3 Departments of International Health and Pediatrics, Johns Hopkins University, Baltimore, MD
4 Department of Pediatrics and the Center for Vaccine Development, University of Maryland School of Medicine, Baltimore
5 Department of Pediatrics, University of Rochester School of Medicine, Rochester, NY
6 Departments of Microbiology and Immunology and Pediatrics, Baylor College of Medicine, Houston, TX
7 Department of Medicine, St Louis University School of Medicine, Bethesda, MD
8 Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, Bethesda, MD

Objective. To compare the reactogenicity of a licensed conventional whole-cell (WCL) and 13 acellular pertussis vaccines that differed in the source, manufacture, and quantity of included antigens; all vaccines included diphtheria and tetanus toxoids.

Methods. Healthy infants were enrolled through six university-based vaccine and treatment evaluation 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, redness, swelling, pain, fussiness, drowsiness, anorexia, and use of antipyretics for 2 weeks after each inoculation; nurses interviewed parents on the third day and at each succeeding visit; long-term follow-up information was collected from parents and medical records 1 year after the third immunization.

Results. Of 2200 vaccinated infants, 2189 contributed reaction data after 6375 vaccinations. For every acellular vaccine, every monitored reaction except vomiting occurred at a significantly lower frequency and severity than was seen with WCL. The groups receiving acellular pertussis vaccines differed significantly with respect to redness, swelling, pain, and vomiting, but not with respect to fussiness, antipyretic use, drowsiness, or anorexia.

Conclusion. Although there were differences among the acellular vaccines, none was consistently the most or least reactogenic; all were associated with substantially fewer and less severe adverse reactions than a standard commercial whole-cell vaccine. Selection of acellular vaccines for further development and for introduction into efficacy trials can give priority to assessments of immunogenicity and purity, with comparative reactogenicity a secondary consideration.




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