The trial will take place in 525 subjects at various sites.
The sites include AIIMS-Delhi, AIIMS-Patna and Meditrina Institute of Medical Sciences, Nagpur.
Bharat Biotech’s Covaxin has been recommended for trials on 2-18 year olds by a panel of experts. The approval was provided on Tuesday for phase II/III clinical trial.
The trial will take place in 525 subjects at various sites which include AIIMS Delhi and Patna and Meditrina Institute of Medical Sciences, Nagpur.
The Subject Expert Committee deliberated upon Bharat Biotech’s application seeking permission to conduct phase II/III clinical trials to evaluate the safety, reactogenicity and immunogenicity of Covaxin jabs in children aged 2 to 18 years.
"After detailed deliberation, the committee recommended for conduct of proposed phase II/III clinical trial of whole virion inactivated coronavirus vaccine in the 2 to 18 years age group subject to the condition that the firm should submit the interim safety data of phase II clinical trial along with DSMB recommendations to the CDSCO before proceeding to phase III part of the study," as informed by a source.
It may be noted that Covaxin is being used presently in adults in the ongoing vaccination drive in India.
(news source: TOI and TNIE).