Sanofi Pasteur, the vaccines division of Sanofi, announced today the start of a phase III clinical trial in India for its investigational rotavirus vaccine, developed and manufactured by its affiliate Shantha Biotechnics in Hyderabad, India. The trial is designed to show non-inferiority against a currently licensed 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 4 weeks intervals. Close to 1,200 volunteers are being sought at 12 clinical trial sites in India. Shantha’s investigational rotavirus vaccine includes antigens against serotypes G1, G2, G3 and G4.
A phase I/II study was carried out with the long-term aim to produce a locally licensed vaccine that is safe and able to protect children against rotavirus gastroenteritis. Overall, the results showed that all three doses of the vaccine evaluated in the study were safe, well tolerated and displayed good immunogenicity (dose–response) in healthy Indian infants.
“We aim to provide an affordable vaccine to meet the still significant medical need in emerging markets, like India, and through partnerships with organizations like Gavi, the Vaccine Alliance”, commented Olivier Charmeil, Sanofi Pasteur’s President & CEO. “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.”
The World Health Organization (WHO) recommends that vaccination with rotavirus vaccines should be included in all national immunization programs. Gavi, has established an accelerated vaccine introduction initiative with the objective of driving the sustainable introduction of rotavirus vaccine in 30 Gavi-eligible countries by 2015. In addition, PATH, an international, non-profit organization to improve public health, is working to accelerate access to rotavirus vaccines and sustain their implementation and use in countries where children need them most urgently.