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Updated: Jun 24, 2026

Assays for the Specific Growth Rate and Cell-binding Ability of Rotavirus
Published on: January 28, 2019
A live attenuated human rotavirus vaccine
1Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Division of Infectious Diseases, Department of Pediatrics, Cincinnati, Ohio 45229, USA. David.Bernstein@cchmc.org
Insights
Rotarix is a safe and effective live oral rotavirus vaccine for children, offering 85-100% efficacy against severe gastroenteritis. This vaccine, administered in two doses, protects against common rotavirus serotypes worldwide.
Area of Science:
- Pediatrics
- Vaccinology
- Virology
Background:
- Rotavirus infections are a primary cause of severe gastroenteritis in young children globally.
- Development of effective vaccines is crucial for reducing childhood morbidity and mortality.
Purpose of the Study:
- To review the development and clinical evaluation of Rotarix, a live oral rotavirus vaccine.
- To summarize the safety and efficacy data from large-scale clinical trials.
Main Methods:
- Development of Rotarix involved attenuation of a wild-type human rotavirus strain (89-12, G1P[8]) through multiple tissue culture passages.
- Extensive safety and efficacy trials were conducted, involving over 100,000 children worldwide.
Main Results:
- Rotarix demonstrated a favorable safety profile, with no association with intussusception.
- The vaccine is highly immunogenic and provides 85-100% efficacy against severe rotavirus gastroenteritis and hospitalization.
- Protection extends to the most common circulating human rotavirus serotypes.
Conclusions:
- Rotarix is a safe and effective vaccine for preventing rotavirus gastroenteritis in children.
- The vaccine is globally available and recommended as a two-dose oral regimen starting from 6 weeks of age.
Abstract:
Rotavirus infections are the leading cause of severe gastroenteritis in young children worldwide. This review provides a summary of the development of a live oral rotavirus vaccine, Rotarix (GlaxoSmithKline, Rixensart, Belgium) developed from a single protective G1P[8] human strain. To attenuate the wild-type virus, the original isolate, 89-12, was passaged multiple times in tissue culture. Large safety and efficacy trials that have included more than 100,000 children around the world have shown the vaccine is safe and not associated with intussusception. The vaccine is highly immunogenic and protective against disease caused by all the most common circulating human serotypes. Efficacy against severe rotavirus gastroenteritis and hospitalization has ranged from 85-100%. Rotarix is available in the European Union, most countries in Latin America, Australia, and numerous other countries around the world. The vaccine is administered as two oral doses with at least four weeks between doses. The first dose may be administered from the age of 6 weeks, and both doses should be completed by 24 weeks of age.
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