The study results demonstrated that Rotarix prevented the disease in 61.2% of these infants. It also showed that Rotarix provided broad protection against diverse circulating rotavirus strains and is generally well-tolerated.
Reportedly, in South Africa and Malawi, more than 4 900 infants were enrolled in clinical trials examining the efficacy of Rotarix. Healthy babies were randomised (1:1:1) to receive placebo followed by two doses of Rotarix, three doses of Rotarix or three doses of placebo, respectively, at six, ten and 14 weeks of age with routine childhood vaccines, including oral poliovirus vaccine.
In the study, the episodes of gastroenteritis caused by circulating wild-type rotavirus during the first year of life were assessed through active follow-up and graded for severity using the Vesikari scale.
The trial was designed to accumulate data from Africa and include populations that would be broadly representative of those in developing countries. These data suggest that, when introduced into standard childhood vaccination schedules in similar settings across Africa, Rotarix is expected to have a considerable public health benefit.