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Every year, an estimated 425,000 infants in developing Asian and African countries die of rotavirus infections. In two multicenter, double-blind trials, researchers assessed the efficacy and safety of RotaTeq, an oral pentavalent rotavirus vaccine, in such countries. Both trials were partially funded by the vaccine maker.
Zaman and colleagues randomized 2036 infants in rural Bangladesh and urban and periurban Vietnam to receive three doses of vaccine or placebo at about 6, 10, and 14 weeks of age. The investigators did not test for HIV or exclude HIV-positive infants. Participants received other routine vaccines, including oral poliovirus vaccine. Median age was 21 months at study end.
In per-protocol analysis, vaccine efficacy against severe…