The choice of endpoint was most important for an efficacy vaccine trial. The objective of this paper is to gear toward answering questions about the rationality and scientificity of the primary endpoints choosing, case capturing and diagnosis strategy in our recently reported EV71 vaccine efficacy phase 3 trial. In order to obtain both high sensitivity and specificity in the case detecting, EV71-associated disease had been chosen as primary endpoint, a broad spectrum of clinical symptoms was surveyed, both the real-time RT-PCR and virus isolation were combined for the laboratory diagnosis, and serial specimens since disease onset were collected for assays. Though, the EV71 vaccine efficacy was well measured in the phase 3 trial, several potential factors could also have influences on the cases confirming. More evidence of EV71 vaccine efficacy will be demanded in post-marketing studies in the future.
Keywords: efficacy; enterovirus type 71; foot and mouth disease; hand; sensitivity; specificity; vaccine.