PARIS (dpa-AFX) - Drugmaker Sanofi's (SNYNF, SNY) vaccines division, Sanofi Pasteur, Tuesday announced 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 in healthy Indian infants.
Copyright RTT News/dpa-AFX