Sanofi Pasteur, the vaccines division of Sanofi, has started 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.
Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, rare diseases, consumer healthcare, emerging markets and animal health.
| Company Name | CMP |
|---|---|
| Sun Pharma. Inds. | 1938.85 |
| Dr. Reddys Labs. | 1269.80 |
| Cipla | 1441.70 |
| Zydus Lifesciences | 1159.85 |
| Lupin | 2502.90 |
| View more.. | |
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