COVID-19: Dr Reddy s gets DCGI nod for Phase 3 clinical trials for Sputnik V vaccine
Earlier this week, the Data and Safety Monitoring Board (DSMB) reviewed safety data from Phase 2 clinical trials of the Sputnik V vaccine for COVID-19, and recommended Phase 3 recruitment.
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Drugs Control General of India (DCGI) to conduct Phase 3 clinical trials for the
Sputnik V vaccine for COVID-19.
The Phase 3 study of Sputnik V will be conducted on 1,500 subjects as part of the randomised, double-blind, parallel-group, placebo-controlled study in the country, the Hyderabad-based firm said in a regulatory filing.
Earlier this week, the Data and Safety Monitoring Board (DSMB) reviewed safety data from the Phase 2 clinical trial of the vaccine and recommended Phase 3 recruitment.
Dr Reddy s Laboratories on Friday said it has received approval from the Drugs Control General of India (DCGI) to conduct phase 3 clinical trial for the Sputnik V vaccine for COVID-19.