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 gets nod to conduct Phase 3 clinical trials of Sputnik-V in India
Phase 3 clinical trials of Sputnik-V will be conducted on 1,500 people as part of the randomised, double-blind, parallel-group, placebo-controlled study in India.
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UPDATED: January 16, 2021 08:44 IST
The Phase 3 trials of Sputnik-V are likely to start by January end in India. (Photo: AFP)
Hyderabad-based Dr Reddy s Laboratories has received approval from the Drugs Control General of India (DCGI) to conduct Phase 3 clinical trials for Russia s Sputnik-V Covid-19 vaccine candidate in India.
The Phase 3 trials of Sputnik-V will be conducted on 1,500 people as part of the randomised, double-blind, parallel-group, placebo-controlled study in India.
Earlier this week, the Data and Safety Monitoring Board (DSMB) reviewed the safety data from the phase 2 clinical trial of the Sputnik V vaccine and recommended phase 3 recruitment.
Dr Reddy’s gets nod to conduct Phase 3 clinical trial for Sputnik V vaccine in India
January 16, 2021
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Dr. Reddy’s Laboratories Ltd has 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 1,500 subjects as part of the randomized, double-blind, parallel-group, placebo-controlled study in India.
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.