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Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (BNT162b1) in Chinese Healthy Subjects

SARS-CoV-2 Clinical Trial

Official title:
Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (BNT162b1) in Chinese Healthy Subjects: A Phase I, Randomized, Placebo-controlled, Observer-blind Study

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04523571
Study type Interventional
Source BioNTech SE
Contact
Status Completed
Phase Phase 1
Start date July 28, 2020
Completion date August 10, 2021
View Details
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