GlaxoSmithKline, which awaits the Indian regulatory approval for its newly developed vaccine to prevent rotavirus infection in children, is all set to launch the clinical trials in the country by April.
The multi-centric vaccine trials will be conducted in five major centres including New Delhi, Chandigarh and Mumbai. The company is currently in the process of appointing investigators and recruiting volunteers in all these centres, informed Dr Sanjoy K Datta, director, Clinical R&D and Medical Affairs, Vaccines- South Asia, of GSK Biologicals.
GSK, the world major in vaccines, introduced the vaccine-Rotarix in Mexico as a first step of the company's global launch, in January this year. Rotavirus infection, the leading cause of severe diarrhoea and vomiting in infants and young children between 6 and 36 months worldwide, is fatal if untreated as the sickest children become dehydrated from 10 to 20 episodes of diarrhoea in a single day.
Globally, rotavirus infections account for approximately 138 million cases of infantile gastroenteritis each year and are responsible for approximately 440,000 deaths per year globally, said Dr Datta.
Dr Datta informed that Rotarix would be launched in many other Latin American countries and Asia Pacific countries, in 2005. The product has been already filed in more than 20 countries worldwide. "In the case of Rotarix, the company has focused its clinical and regulatory strategy first on countries where the medical need for a rotavirus vaccine is high," he added.
As part of the global trials for Rotarix, more than 70,000 infants were enrolled and the studies were conducted in Europe, the US, Latin America, Africa and Asia. The Phase III clinical study in over 60,000 infants aged 6 weeks to 6 months conducted in 11 Latin American countries and in Finland confirmed that the vaccine is safe and well tolerated.
Dr Datta said that in the earlier trials, the vaccine has demonstrated up to 90 per cent efficacy against severe rotavirus-related gastroenteritis in the first year of life. It has also demonstrated protection against circulating strains that were different from the vaccine strain.
The rotavirus vaccine has been in development at GSK Biologicals since 1997 when it was in-licensed from AVANT Immunotherapeutics. The vaccine was originally developed by Dr Richard Ward at the Children's Hospital of Cincinnati.