All Times EDT
Keywords: vaccine, multivalent, immunogenicity
The development of multivalent vaccines with broader coverage is critical to meet the evolving medical and public health needs. The new generation of vaccine often contains most (if not all) serotypes in the previous generation, and additional serotypes to protect against the majority of the remaining infections. Take the pneumococcal conjugate vaccine (PCV) as an example, PCV7, PCV10, and PCV13 have been licensed since 2000, and the investigational PCV15 and PCV20 are currently under development. Typically, the comparison of the immunogenicity results between different generations is specifically performed for each of the shared serotypes, but the comparison for the additional serotypes in the new generation is controversial. One idea is to compare the immunologic responses of the additional serotypes in the new generation to the serotype with the lowest responses among the shared serotypes in the old generation directly, but such direct comparison is lack of clinical and statistical justification. In this presentation, we will propose a novel approach in comparing the additional serotypes between two generations of vaccine. This approach will be demonstrated by a set of simulation studies and illustrated by a real data example.