Who is sponsoring NCT04641481?

NCT04641481 is sponsored by Bharat Biotech International Limited.

What condition does NCT04641481 study?

NCT04641481 studies Covid19, SARS-CoV Infection.

What drugs are being tested in NCT04641481?

Interventions: BBV152, Placebo.

What is the status of NCT04641481?

NCT04641481 is currently UNKNOWN.

Last reviewed 2021-03-18 · How we verify

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

NCT04641481 Phase 3 UNKNOWN

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.

Details

Lead sponsor	Bharat Biotech International Limited
Phase	Phase 3
Status	UNKNOWN
Enrolment	25800
Start date	2020-11-16
Completion	2022-12

Conditions

Covid19
SARS-CoV Infection

Interventions

BBV152
Placebo

Primary outcomes

First occurrence of Virologically confirmed (RT-PCR positive) symptomatic cases of COVID-19. — Day 42 to Month 12
(RT-PCR positive) symptomatic cases of COVID-19.

Countries

India