Sanofi Pasteur MSD, a joint venture of French drug major Sanofi-Aventis' vaccines division and USA-based Merck & CO, has presented new data on its RotaTeq oral rotavirus vaccine, at the International Congress for Infectious Diseases in Kuala Lumpur, Malaysia.
Combined results of the REST trial and its extension FES, show that the pentavalent oral vaccine provided a 94% efficacy over 3.1 years in reducing hospitalizations and accident and emergency department visits due to rotavirus gastroenteritis. These results were consistent with data gathered at one year and two years of follow-up.
The double-blind, placebo-controlled, Phase III clinical REST study enrolled almost 70,000 infants worldwide and administered RotaTeq or placebo at four to 10 week intervals. The FES extension study tracked patients every 12 weeks to determine if any hospital visits had been required due to the disease. Rotateq has shown efficacy against five rotavirus types: G1, G2, G3, G4 and G9. These five cause more than 98% of pediatric rotavirus disease in Europe, the firm notes.
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