NCT04588480

Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Japanese Adults

A PHASE 1/2, PLACEBO-CONTROLLED, RANDOMIZED, AND OBSERVER-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A SARS-COV-2 RNA VACCINE CANDIDATE AGAINST COVID-19 IN HEALTHY JAPANESE ADULTS

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: BioNTech SE · Industry
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1/2, randomized, placebo-controlled, and observer-blind study in healthy Japanese adults. The study will evaluate the safety, tolerability, and immunogenicity of the SARS-CoV-2 RNA vaccine candidate against COVID-19: * As 2 doses, separated by 21 days * At a single dose level * In adults 20 to 85 years of age

Detailed description

From protocol amendment 3, this study is transitioned from a clinical trial to a postmarketing study (Phase 4) according to the Japanese regulation, because BNT162b2 was approved by the Ministry of Health, Labour and Welfare on 14 February 2021.

Conditions

• SARS-CoV-2 Infection
• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	BNT162b2	BNT162b2 (intramuscular injection)
OTHER	Placebo	Placebo (intramuscular injection)

Timeline

• Start date: 2020-10-21
• Primary completion: 2021-11-25
• Completion: 2021-11-25
• First posted: 2020-10-19
• Last updated: 2023-02-01
• Results posted: 2023-02-01

Locations

2 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study