Trials / Completed
CompletedNCT04523571
Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (BNT162b1) in Chinese Healthy Subjects
Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (BNT162b1) in Chinese Healthy Subjects: A Phase I, Randomized, Placebo-controlled, Observer-blind Study
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 144 (actual)
- Sponsor
- BioNTech SE · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Accepted
Summary
This was a phase I, randomized, placebo-controlled, observer-blind study, for evaluation of safety and immunogenicity of SARS-CoV-2 mRNA vaccine (BNT162b1) in Chinese healthy population.
Detailed description
The participants were screened for 2 weeks (Day -14 to Day 0) before randomization, and received 1 dose of SARS-CoV-2 vaccine (BNT162b1) or placebo intramuscularly (IM) on Day 1 and Day 22, respectively. After randomization, the study for each participant lasted for approximately 12 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | BNT162b1 | Intramuscular injection |
| OTHER | Placebo | Intramuscular injection |
Timeline
- Start date
- 2020-07-28
- Primary completion
- 2020-09-30
- Completion
- 2021-08-10
- First posted
- 2020-08-21
- Last updated
- 2023-09-18
- Results posted
- 2023-09-18
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04523571. Inclusion in this directory is not an endorsement.