An Efficacy and Safety Clinical Trial of an Investigational COVID-19 Vaccine (BBV152) in Adult Volunteers

Phase 3 Unknown 25800 enrolled Bharat Biotech International Limited IQVIA Pty Ltd · collab Indian Council of Medical Research · collab

RandomizedParallel-groupQuadruple-blindPrevention

Summary

The BBV152 vaccine is being developed to prevent COVID-19, the disease resulting from Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) infection. The study is designed to primarily evaluate the efficacy, safety, and immunogenicity of BBV152 to prevent COVID-19 for up to 1 year after the second dose of BBV152.

Timeline

Start: 2020-11-16
Primary completion: 2021-01-08
Completion: 2022-12

Outcome

Met primary endpoint

paper 24 (0·3%) cases occurred among 8471 vaccine recipients and 106 (1·2%) among 8502 placebo recipients, giving an overall estimated vaccine efficacy of 77·8% PMID 34774196 ↗

release “Phase 3 results demonstrated that COVAXIN™ (BBV152) has 93.4% efficacy against severe COVID-19 disease, 77.8% overall efficacy” ocugen.com ↗

Publications

Ella R, Reddy S, Blackwelder W, Potdar V, Yadav P, Sarangi V, Aileni VK, Kanungo S, Rai S, Reddy P, Verma S, Singh C, Redkar S, Mohapatra S, Pandey A, Ranganadin P, Gumashta R, Multani M, Mohammad S, Bhatt P, Kumari L, Sapkal G, Gupta N, Abraham P, Panda S, Prasad S, Bhargava B, Ella K, Vadrevu KM; COVAXIN Study Group. Efficacy, safety, and lot-to-lot immunogenicity of an inactivated SARS-CoV-2 vaccine (BBV152): interim results of a randomised, double-blind, controlled, phase 3 trial. Lancet. 2021 Dec 11;398(10317):2173-2184. doi: 10.1016/S0140-6736(21)02000-6. Epub 2021 Nov 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BBV152	Vaccine	6 ug	Intramuscular