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ARTICLE | Clinical News

Rotavac: Phase III data

May 20, 2013 7:00 AM UTC

Data from the intent-to-treat (ITT) population of 6,799 infants aged 6-7 weeks at the time of enrollment in a double-blind, Indian Phase III trial showed that oral Rotavac met the primary endpoint of reducing the incidence of severe rotavirus diarrhea vs. placebo. Specifically, Rotavac reduced the endpoint by 57.3% during the first year of life vs. placebo (p<0.0001). In the per protocol (PP) population consisting of subjects that received all 3 doses of Rotavac or placebo (n=6,541), Rotavac significantly reduced the endpoint by 56.4% during the first year of life vs. placebo (p<0.0001). Bharat said protection from severe rotavirus diarrhea continued to a median age of 17 months at the time of analysis. In the ITT population, Rotavac also significantly reduced severe gastroenteritis requiring hospitalization or supervised rehydration therapy vs. placebo (p<0.0001).

Subjects received 3 doses of Rotavac or placebo at 6, 10 and 14 weeks of age co-administered with childhood vaccines against diphtheria, pertussis, tetanus, influenza B, HBV and polio. Data were presented at the International Symposium on Rotavirus Vaccines for India in New Delhi. The vaccine was developed in collaboration with the India's Department of Biotechnology, NIH's National Institute of Allergy and Infectious Diseases (NIAID), the U.S. Centers for Disease Control and Prevention, Stanford University School of Medicine, the Bill & Melinda Gates Foundation and Program for Appropriate Technology in Health (PATH). ...