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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: PATH, GAVI Alliance

Published: 2006

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831 KB PDF

Resource types: Report, PATH resource

Diseases/vaccines: Rotavirus

Topics: Disease/vaccine specific information

Regions: Global