The Development of Live, Attenuated Rotavirus Vaccines: A Manufacturer's Resource Guide
This guide is a compilation of publicly available information about the manufacturing process of rotavirus vaccines, and aims to provide a resource for manufacturers interested in developing and registering an attenuated, oral rotavirus vaccine. Highlights cover various decisions to be made during development; examples of preclinical studies, manufacturing processes, assay procedures, and clinical trial strategies; and advantages and disadvantages of multiple scenarios at each development milestone.
Author(s): PATH, GAVI Alliance
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