Adverse reactions of a pertussis toxoid vaccine in a double-blind placebo-controlled trial.

In the Gothenburg study, 3,450 infants were randomly assigned to receive three subcutaneous injections of acellular pertussis vaccine consisting of peroxide-inactivated pertussis toxin with diphtheria and tetanus toxoids (DTP-toxoids) or DT-toxoids alone under blind conditions at three, five and 12 months of age. Safety of the vaccinations was assessed by direct contact with the families in the week following each injection. No serious vaccine-associated adverse reactions were observed, in either group. The frequency of fever and local reactions increased by dose. Redness and swelling were slightly but significantly more frequent in recipients of DTP-toxoids compared to the DT group.