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An Event-Driven, Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate Efficacy, Safety, Immunogenicity, Lot-to-Lot Consistency of BBV152, a Whole-Virion Inactivated SARS-CoV-2 Vaccine in Adults≥18 Yrs of Age

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Trial Profile

An Event-Driven, Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate Efficacy, Safety, Immunogenicity, Lot-to-Lot Consistency of BBV152, a Whole-Virion Inactivated SARS-CoV-2 Vaccine in Adults≥18 Yrs of Age

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 06 Mar 2023

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At a glance

  • Drugs BBV 152 (Primary)
  • Indications COVID 2019 infections
  • Focus Registrational; Therapeutic Use
  • Sponsors Bharat Biotech

    • Most Recent Events

    • 15 Nov 2021 Interim results published in the Lancet
    • 11 Nov 2021 Results published in Ocugen Media Release.
    • 05 Nov 2021 According to a Ocugen media release, it has submitted a request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of COVID-19 vaccine candidate BBV152, known as COVAXIN outside of the U.S., for pediatric use.The submission is based on results from NCT04918797 and this trial.

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