GlaxoSmithKline to Trial Rotavirus Vaccine in India

The vaccines unit of UK-based drug major GlaxoSmithKline, GSK Biologicals, is to conduct clinical trials in India for its new vaccine for rotavirus, a highly virulent cause of potentially fatal gastroenteritis in young children, mainly in developing countries. The product, known as Rotarix, has already been launched in Mexico as the first step in a phased global launch. A five-centre trial will now be carried out in India.

The drug has already undergone trials on human subjects in several countries, although the recent scaling back of clinical trials restrictions in India will now enable GSK to broaden the scope of its studies. Further, the company may wish to see if the vaccine is effective against Asian variant strains of the virus, as appears from trials elsewhere. Such efforts are likely to be aided by India's large and ethnically diverse pool of potential trial volunteers.