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Abstract:
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In the late stage vaccine development, it is common that more than one formulation is proposed in the Phase II proof-of-concepts (POC) trial. These proposed formulations generally have the equal level of importance and will all be considered as primary endpoints, therefore multiplicity needs to be adjusted for the multiple primary endpoints. The Hochberg Approach is a popular approach to control the family-wise Type I Error Rate under this scenario. In the presentation, we will first briefly explain why the Hochberg approach is preferable to other approaches. Then, we will illustrate the application of the Hochberg approach in a Phase II POC Trial of the Merck Pneumococcal Vaccine Program and evaluate how this will impact the formulation selection before proceeding to Phase III trials.
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