Trials / Completed
CompletedNCT04510207
A Study to Evaluate The Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) in Healthy Population Aged 18 Years Old and Above
Multicenter, Randomized, Double Blind, Parallel Placebo Controlled, Phase III Clinical Trial to Evaluate the Protective Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) in Healthy Population Aged 18 Years Old and Above
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 44,101 (actual)
- Sponsor
- China National Biotec Group Company Limited · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
This is a multicenter, randomized, double blind, parallel placebo controlled, phase 3 clinical trial to evaluate the protective efficacy, safety and immunogenicity of inactivated SARS-CoV-2 vaccines in healthy population 18 years old and above.
Detailed description
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the protective efficacy, safety and immunogenicity of inactivated SARS-CoV-2 vaccines in healthy population 18 years old and above. The participants were randomized into three groups of investigational vaccine 1, investigational vaccine 2 and placebo in a 1:1:1 ratio.2 doses of the investigational vaccine or placebo are inoculated into the deltoid muscle of the either arm according to the vaccination schedule of D0 \& D21 (+7 days).According to the immune durability results in Phase I/II study, and cross-neutralization assay results, a third dose (booster dose) generates a better immune response and is estimated to offer better protection, therefore, a booster dose will be given after 3 months
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Inactivated SARS-CoV-2 Vaccine (Vero cell) | The inactivated SARS-CoV-2 Vaccine (Vero cell) manufactured by WIBP |
| BIOLOGICAL | Inactivated SARS-CoV-2 Vaccine (Vero cell) | The inactivated SARS-CoV-2 Vaccine (Vero cell) manufactured by BIBP |
| BIOLOGICAL | Placebo | The placebo of inactivated SARS-CoV-2 Vaccine (Vero cell) manufactured by WIBP |
Timeline
- Start date
- 2020-07-16
- Primary completion
- 2021-06-16
- Completion
- 2021-12-31
- First posted
- 2020-08-12
- Last updated
- 2023-06-18
Locations
6 sites across 4 countries: Bahrain, Egypt, Jordan, United Arab Emirates
Source: ClinicalTrials.gov record NCT04510207. Inclusion in this directory is not an endorsement.