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PEDIATRICS Vol. 112 No. 6 December 2003, pp. e453-e459

Injection-Site Reactions to Booster Doses of Acellular Pertussis Vaccine: Rate, Severity, and Anticipated Impact

Danuta M. Skowronski, MD, MHSc, FRCPC*, Valencia P. Remple, RN, BSN, MSN*, Jane Macnabb, RN, BSN*, Karen Pielak, RN, MSN*, David M. Patrick, MD, FRCPC, MHSc*, Scott A. Halperin, MD{ddagger} and David Scheifele, MD§

* University of British Columbia Centre for Disease Control, Vancouver, British Columbia, Canada
{ddagger} Clinical Trials Research Center, Dalhousie University, IWK Health Centre, Halifax, Nova Scotia, Canada
§ Vaccine Evaluation Centre, British Columbia Children’s Hospital, Vancouver, British Columbia, Canada

Background. Acellular pertussis (aP)-containing vaccines cause fewer adverse events than whole-cell versions for primary doses. Booster doses, however, may be followed by extensive injection-site reactions. This study compares the frequency, severity, and impact of local reactions among children receiving 5 consecutive doses of an aP combination vaccine (including inactivated polio virus, conjugated Haemophilus influenzae type b antigen, and diphtheria and tetanus toxoids) to children receiving a mixed series of whole-cell and aP combination vaccines.

Methods. Participants were parents or guardians of children 4 to 6 years old immunized at public health clinics across British Columbia, Canada. This included 398 children receiving the fifth consecutive dose of an aP combination vaccine and 402 receiving the fifth dose in a mixed series consisting of at least 1 prior dose of whole-cell pertussis combination vaccine with the remainder as aP combination vaccine. A cross-sectional telephone survey evaluated the extent of local reactions 48 to 96 hours after immunization by asking participants to compare the size of redness and swelling with familiar household items such as Oreo cookies or coins. Associated discomfort and impact on recreational activities, health care utilization, parental time off work, and attitudes toward immunization were also assessed.

Results. Children who received the fifth consecutive dose of an aP combination vaccine more often experienced redness (24%) or swelling (16%) the size of an Oreo cookie or larger (≥46 mm) than children given a mixed series (10% and 9%, respectively) but less often experienced tenderness or limitation of movement at the injection site. Related health care utilization was low. There was no discernible effect on participation in recreational activities or parental attitudes toward vaccine; 90% would recommend the same vaccine to others with children of the same age.

Conclusions. We conclude that injection-site reactions are more extensive after the fifth consecutive dose of an aP combination vaccine compared with the fifth dose in a mixed series of whole-cell and aP combination vaccines. These reactions are unlikely to affect parental acceptance of immunization recommendations or health care utilization.

Key Words: adverse reactions • local adverse reactions • acellular pertussis vaccine • whole-cell pertussis vaccine • vaccine safety • booster doses

Abbreviations: wP, whole-cell pertussis • IPV, inactivated polio virus • Hib, Haemophilus influenzae type b antigen • DT, diphtheria • T, tetanus • aP, acellular pertussis • BC, British Columbia • Lf, limits of flocculation • CI, confidence interval • OR, odds ratio

Received for publication Feb 3, 2003; Accepted Jul 10, 2003.




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