Document is current
Any future updates will be listed below
-
Authors
Desai, Sajjad
Anil, K.
Potey, Anirudha Vyankatesh
Sindhu, Y.
Grappi, Silvia
Lapini, Giulia http://orcid.org/0000-0003-3596-9578
Manney, Satyaprasad
Tyagi, Parikshit
Montomoli, Emanuele
Poonawalla, Cyrus S.
Kulkarni, Prasad S. http://orcid.org/0000-0003-3625-9236
- License Information
-
More Information
Article History
Received: 25 August 2022
Accepted: 6 December 2022
First Online: 19 December 2022
Competing interests
: S.D., A.V.P., S.M., P.T., and P.S.K are employees of Serum Institute of India Pvt. Ltd. (SIIPL). C.S.P. is the chairman and managing director of SIIPL. A.K., S.Y., S.G., G.L., and E.M. have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
: All participants were enrolled only after obtaining written informed consent. The study protocol and documents were approved by the People Tree Hospital Ethics Committee. The study was performed in accordance with the International Conference on Harmonization Guidelines for Good Clinical Practice E6 (R2), New Drugs and Clinical Trials Rules, 2019 by CDSCO and the Declaration of Helsinki, 2013.
: The study was approved by the Drugs Controller General of India. The study is registered on the clinical trial registry of India (CTRI/2020/09/027594).
