Diseases and vaccines
Rotavirus vaccine clinical recommendations and regulatory issues
The development of live, attenuated rotavirus vaccines: A manufacturer's resource guide (2006)
PATH, GAVI Alliance
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.
Guidelines to assure the quality, safety and efficacy of live attenuated rotavirus vaccines (oral) (2005)
WHO
Intended for use by National Regulatory Authorities NRAs and vaccine
manufacturers, this document provides guidelines on production, quality control, and safety/efficacy evaluation of live,
attenuated, oral rotavirus vaccines.
Prevention of rotavirus gastroenteritis among infants and children: Recommendations of the Advisory Committee on Immunization Practices (2006)
US Centers for Disease Control and Prevention (CDC). Morbidity and Mortality Weekly Report. 55(RR-12).
This report provides background on the development of RotaTeq®, Merck's vaccine against rotavirus, and recommendations for its use in the prevention of rotavirus through immunization.
Rotarix® international data sheet (2004)
GlaxoSmithKline
This informational sheet contains prescription information for administration of Rotarix® vaccine.
RotaTeq® package insert (2006)
Merck & Co, Inc.
This document provides information on and directions for administration of Merck's rotavirus vaccine.
Strategic Advisory Group of Experts (SAGE) recommendations (2006)
WHO. Weekly Epidemiological Record. 81(1):8.
This issue of the WHO's weekly newsletter provides recommendations and commentary from a SAGE meeting that recognized the safety of rotavirus vaccines among the populations studied and called for clinical trials to determine the vaccines' safety and efficacy in African and Asian pediatric populations.