Statistical Challenges in Vaccine Clinical Studies: An FDA Perspective
*Amelia Dale Horne, FDA-CBER 

Keywords: Vaccine, Safety, Efficacy, Immunogenicity

This presentation will summarize some of the major statistical issues the FDA must consider in the overall evaluation of preventive vaccines. These issues relate to study design, conduct, and analysis. Ultimately, the FDA must make regulatory decisions regarding licensure and label indications with respect to efficacy, immunogenicity, and safety of the vaccines that are under review. Current issues of interest in evaluating these vaccines will be discussed.