Sanofi Pasteur launches Indian trial of new rotavirus vaccine

Sanofi Pasteur has announced the commencement of a phase III clinical trial in India for a promising investigational rotavirus vaccine.

Developed and manufactured by the company's Hyderabad-based affiliate Shantha Biotechnics, the vaccine is being studied in three ready-to-use liquid doses administered orally, with the trial intended to show non-inferiority against a currently licensed product.

Almost 1,200 volunteers are being sought at 12 clinical trial sites in India for the study, which will administer the vaccine starting from six to eight weeks of age, with subsequent doses given at four-week intervals.

The live, oral, ready-to-use tetravalent rotavirus vaccine candidate is designed to protect young children from severe diarrhoea and includes antigens against serotypes G1, G2, G3 and G4.

Olivier Charmeil, Sanofi Pasteur's president and chief executive officer, said: "We aim to provide an affordable vaccine to meet the still significant medical need in emerging markets, like India, and through partnerships with organisations like Gavi, the vaccine alliance."

This comes after the firm successfully concluded the final phase III trial of its groundbreaking dengue vaccine candidate last month.