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Sanofi Pasteur, the vaccine division of Sanofi, today said it has started phase-III clinical trials for its investigational rotavirus vaccine in India.
The vaccine has been developed and manufactured by its affiliate Shantha Biotechnics in Hyderabad.
The trial is designed to show non-inferiority against a currently licensed vaccine, with use of three, ready-to-use liquid doses administered orally, said the company.
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Sanofi is looking for about 1,200 volunteers at 12 clinical trial sites in India, it said.
"We aim to provide an affordable vaccine to meet the still significant medical needs in emerging markets, like India, and through partnerships with organisations like Gavin, the Vaccine Alliance," said Olivier Charmeil, Sanofi Pasteur's president.
India has the largest disease burden for rotavirus gastroenteritis in the world, according to Harish Iyer, CEO of Shatha. "This vaccine has the potential to offer great benefits for the children in India", he said.
