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.