The consideration about study design and implementation of vaccine clinic trials

Abstract

The safety of prophylactic vaccine is one of the key points both in clinical trials and evaluation. Based on the review practice of vaccine registration clinical trials in recent years, we puts forward a series of thoughts and suggestions on the common problems of safety study on vaccine, including the hypothesis of safety study, the consideration of inclusion/exclusion criteria and suspension/termination criteria for study; the routine requirements of safety study and some special issue such as medical laboratory test index, vaccine virus shedding and safety of adjuvant, and further clarifies the requirements of safety observation on sequential enrollment; also emphasized the scientific judgment of causality and the quality of safety monitoring. It can be used for reference by vaccine researchers and to explore appropriate solutions to promote vaccine research & development and risk control in China.