Sanofi begins late-stage study of rotavirus vaccine in India

Sanofi announced Tuesday the start of a Phase III trial in India for its experimental tetravalent rotavirus vaccine, which includes antigens against serotypes G1, G2, G3 and G4. "We aim to provide an affordable vaccine to meet the still significant medical need in emerging markets, like India," remarked Olivier Charmeil, CEO of Sanofi Pasteur.

An earlier Phase I/II trial showed that all three doses of the vaccine evaluated in the study were safe, well tolerated and displayed good immunogenicity in healthy Indian infants. The late-stage trial, which will include around 1200 volunteers, is designed to show non-inferiority versus a currently licensed rotavirus vaccine with the use of three, ready-to-use liquid doses administered orally, starting from six-to-eight weeks of age, with the subsequent doses administered at four-week intervals.

Sanofi's live-attenuated bovine-human reassortant vaccine, which it gained through the acquisition of Shantha Biotechnics in 2009, is designed to prevent severe rotavirus gastroenteritis in infants and children, with each all-in-one dose containing an antacid. "Sanofi Pasteur wants to be in the position to target a major role in the growing rotavirus market in developing countries, with a key focus on the Gavi market, in public markets for non-Gavi countries, as well as private segments in emerging markets," Charmeil noted.

Currently marketed rotavirus vaccines include GlaxoSmithKline's Rotarix and Merck & Co.'s RotaTeq.

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