The Design and Analysis of Vaccine Trials for Zika and Dengue

Several Zika virus vaccine candidates are proceeding through early phase safety and immunogenicity testing. In this talk, we describe statistical methods for the rapid conduct of phase III vaccine trials for those candidates that proceed to phase III testing. For dengue we describe statistical considerations for a population-level, phase IV trial, with a licensed tetravalent dengue vaccine in Yucatan State, Mexico, for measuring population-level effectiveness.