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COVAXIN™ (BBV152)

Study Overview

A randomized, observer-blind, placebo-controlled immuno-bridging, and broadening study to demonstrate the equivalence of the immune response between participants enrolled in Phase 2/3 efficacy trial in India and demographically diverse healthy adult participants in the US which matched in age and vaccine formulation setting to whom those efficacy results are extrapolated; and to assess the broadening of the BBV152 in participants who previously received two shots of messenger ribonucleic acid (mRNA) COVID-19 vaccine at least 6 months earlier or one-shots of viral vector J&J/Janssen COVID-19 vaccine at least 2 months earlier. Safety and tolerability evaluation is a secondary endpoint.

Currently Recruiting

Yes

For more information

www.clinicaltrials.gov

Questions?

Contact us at clinical.request@ocugen.com

Study Title

A Phase 2/3, Observer-Blind, Immuno-bridging, and Broadening Study of a Whole, Inactivated SARS-CoV-2 Vaccine (BBV152) in Healthy Adults

Medical Condition(s)

Active immunization against SARS-CoV-2 virus infection

Product

Whole-virion inactivated COVID-19 vaccine (BBV152)

Ocugen Protocol Number

OCU-002

Study Dates

February 2022 – March 2023

Phase

2/3

Number of Subjects

400

Sex

Male & Female

Age

18 – 65+

Country

United States