drugset / Trial / NCT04984408
Efficacy, Immunogenicity and Safety of BBIBP-CorV Vaccine Against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection.
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BBIBP-CorV | Vaccine | 4 ug | Intramuscular |
| Subject | BBIBP-CorV | Vaccine | 0.5 ml | Intramuscular |
| Subject | Flu Quadrivalent | Vaccine | 0.5 ml | Intramuscular |