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, Dr Reddy's Laboratories said in a regulatory filing.
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.
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 the safety data from the phase 2 clinical trial of the vaccine and recommended the phase 3 recruitment.
In its report, the DSMB had concluded that no safety concerns were identified and the study met the primary endpoints of safety.
“This is an important milestone in the progress of this pivotal clinical trial of the vaccine. We expect to commence the phase III study within this month and will continue to fast-track our efforts to bring in a safe and efficacious vaccine for the Indian population,” Dr Reddy’s Laboratories Co-chairman and Managing Director G V Prasad said.
In September 2020, the drug major had partnered with the Russian Direct Investment Fund (RDIF) to conduct the clinical trials of the Sputnik V vaccine and for its distribution rights in India.
Sputnik V, developed by the Gamaleya National Research Institute of Epidemiology and Microbiology, was registered by the Ministry of Health of Russia and became the world’s first registered vaccine against COVID-19 based on the established human adenoviral vector platform.
The vaccine’s efficacy is confirmed at 91.4 per cent based on data analysis of the final control point of clinical trials in Russia.
Currently, the vaccine’s clinical trials are underway in the UAE, Egypt, Venezuela and Belarus, while it has been registered in Algeria, Argentina, Belarus, Bolivia and Serbia for inoculation.