Akula, Venkateshwar Rao
Bhate, Amit Suresh
Gillurkar, Chandrasekhar S.
Kushwaha, Jitendra Singh
Singh, Ajeet Pratap
Singh, Chandramani
Pandey, Anil Kumar https://orcid.org/0000-0002-4885-8191
K. K, Shivaraj
Rai, Sanjay K.
Vadrevu, Krishna Mohan https://orcid.org/0009-0002-2477-4580
,
Ganneru, Brunda
Chiteti, Siddharth Reddy
Kataram, Sreenivas
Ella, Raches
Prasad, Sai. D
Article History
Received: 10 June 2023
Accepted: 21 March 2025
First Online: 23 April 2025
Competing interests
: The authors declare no competing interest. K.M.V., B.G., S.R.C., K.S., R.E., and S.P. are employees of Bharat Biotech, with no stock options or incentives. A.V.R., A.R.B., C.S.G., J.S.K., A.P.S., C.S., A.K.P., S.K.K., and S.K.R. were principal investigators representing the study sites. Authors from Bharat Biotech and Principal Investigators had final responsibility for the decision to submit for publication. The study sponsor had no role in biostatistical analysis and in writing the report, which was done by the Contract Research Organization (CRO). CRO is responsible for unblinding. K.M.V. and S.R.C. from Bharat Biotech, and the contract research organization had full access to the data in the study, after unblinding.