A two-year follow-up study has shown that Rotateq rotavirus vaccine has reduced cases of severe rotavirus gastroenteritis in infants in developing countries by 48% in Asia and 39% in Africa.
The randomised, placebo-controlled clinical trial was designed to evaluate the efficacy of three doses of the oral pentavalent vaccine in preventing severe rotavirus gastroenteritis versus placebo.
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The vaccine was trialed in Bangladesh, Vietnam, Ghana, Kenya and Mali in infants between four and 12 weeks of age.
The primary endpoint was rotavirus gastroenteritis occurrence anytime after 14 days following the third dose, until the end of the trial.
In Asia, there were 38 reported cases of severe rotavirus gastroenteritis in the vaccine group of 1,018 infants who received Rotateq, compared to the 71 reported cases in the same size placebo group, resulting in a vaccine efficiency of 48.3%.
In Africa, 2,733 infants received Rotateq and 2,735 received a placebo. There were 79 reported cases of severe rotavirus gastroenteritis in the vaccine group, compared to 129 reported cases in the placebo group, resulting in vaccine efficiency of 39.3%.
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