NCT04649021

Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (BNT162b2) in Chinese Healthy Population

Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (BNT162b2) in Chinese Healthy Population: A Phase II, Randomized, Placebo-controlled, Observer-blinded Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 960 (actual)
• Sponsor: BioNTech SE · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

This was a phase II, randomized, placebo-controlled, observer-blinded study of the safety and immunogenicity of SARS-CoV-2 messenger RNA (mRNA) vaccine (BNT162b2) in Chinese healthy population. After randomization, the trial for each participant lasted for approximately 13 months. Screening period was 2 weeks prior to randomization (Day -14 to Day 0), and two doses of either SARS-CoV-2 vaccine (BNT162b2) or placebo were given intramuscularly (IM) separated by 21 days.

Conditions

• SARS-CoV-2

Interventions

Type	Name	Description
BIOLOGICAL	BNT162b2	Intramuscular injection
OTHER	Placebo	Intramuscular injection

Timeline

• Start date: 2020-12-04
• Primary completion: 2021-02-07
• Completion: 2022-01-09
• First posted: 2020-12-02
• Last updated: 2026-03-20

Locations

1 site across 1 country: China