drugset / Trial / NCT04984408

Efficacy, Immunogenicity and Safety of BBIBP-CorV Vaccine Against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection.

NCT04984408

Phase 3 Unknown 8825 enrolled International Vaccine Institute
RandomizedParallel-groupTriple-blindPrevention

Summary

To expand the access and delivery of COVID-19 Vaccines in Africa (ECOVA), the investigators will conduct a phase 3, individually randomized, observer-blind, controlled (influenza vaccine) trial to evaluate the safety and efficacy of the BBIBP-CorV vaccine against any severe acute respiratory syndrome 2 (SARS-CoV- 2) infection among adults 18 years and older. The BBIBP-CorV vaccine is an inactivated SARS-CoV-2 vaccine (Vero cell) manufactured by the Beijing Institute of Biological Products (BIBP), China National Biotec Group (CNBG), Sinopharm, Beijing, People's Republic of China and received emergency use authorization (EUA) from World Health Organization (WHO).

Timeline

Start
2021-10-01
Primary completion
2024-09-30
Completion
2024-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject BBIBP-CorV Vaccine 4 ug Intramuscular
Subject BBIBP-CorV Vaccine 0.5 ml Intramuscular
Subject Flu Quadrivalent Vaccine 0.5 ml Intramuscular

Indications