Case definitions.

Abstract

The definition of a case of pertussis is an essential point in evaluating and comparing the results from the seven studies on pertussis vaccines presented at the Symposium. An assessment of the impact of case definition on the evaluation of vaccine efficacy has been performed on the Italian data-set, by comparing the clinical presentation of cough illnesses which were laboratory-confirmed as B. pertussis infection with those not-confirmed, by study vaccine. The results show that the estimate of vaccine efficacy is greatly variable by the choice of case definition and dependent on the study design. The assessment of the effect of each vaccine should be performed by using various clinical endpoints and the method used in detection of suspected cases in each study should be carefully evaluated to verify comparability of results.