COVAXIN™ (BBV152)
OCU400
COVAXIN
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
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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
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