Pharma major Dr Reddy’s Laboratories Ltd on Friday announced that it has received approval from the Drugs Control General of India (DCGI) to conduct Phase 3 clinical trial for the Sputnik V vaccine in India.
The Phase 3 study of Sputnik V will be conducted on 1500 subjects as part of the randomised, double-blind, parallel-group, placebo-controlled study in India, the Hyderabad-based company said in a statement.
Earlier, the Data and Safety Monitoring Board (DSMB) reviewed the safety data from the Phase 2 clinical trial of the vaccine and recommended the Phase 3 recruitment. In its report, the DSMB concluded that no safety concerns were identified and the study met the primary endpoints of safety.
G.V. Prasad, Co-chairman and Managing Director, Dr Reddy’s Laboratories, termed this as an “important milestone in the progress of this pivotal clinical trial of the vaccine”. “We expect to commence the Phase 3 study within this month and will continue to fast-track our efforts…