Online Program

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Thursday, September 13
Thu, Sep 13, 4:15 PM - 5:30 PM
Lincoln 6
Statistical Challenges and Opportunities in Vaccine Development

Estimation of Correlates of Protection on Different Virus Strains Based on Clinical Vaccine Efficacy Trial (300764)

Martin Dupuy, Sanofi Pasteur 
*Ya Meng, Sanofi Pasteur 
Camille Salamand, Sanofi Pasteur 

Keywords: Vaccine, Clinical Efficacy trials, Correlates of Protection, Estimation

Correlates of Protection is generally used as the investigational endpoints to further evaluate the protection from a vaccine on top of the analysis of efficacy. In some infectious disease, there are different virus strains with homologous virus strains which could be interested to see the protection from a vaccine. Descriptive analyses with advanced modeling methodologies are applied to a phase 3 efficacy trials. The results are compared to the analyses of efficacy endpoints which could further support the bridging strategy commonly used for pivotal trials to avoid a phase 3 efficacy trial.