Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Japanese Adults
Trial status:Study Complete
Study Identifier:
C4591005
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
Sponsor:
The sponsor of a clinical trial is the company, institution or individual that takes responsibility for initiating, managing, and/or financing a clinical investigation. BioNTech collaborates with other pharmaceutical companies or institutions (collaborators) to develop certain new medicines. In particular cases BioNTech's collaborators are leading specific clinical trials and are acting as sponsors accordingly.
BioNTech SE
Study Complete
Results available
Study Protocol
Available Language(s): English
Statistical Analysis Plan
Available Language(s): English
Trial details
Medical Condition
Study Drug
Phase
Phase 4
Sex
Female & Male
Age
20 - 85 Years
Estimated Trial Date
Oct 2020 - Nov 2021
Protocol 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
Trial locations
Location
Status
Location
SOUSEIKAI Sumida Hospital
Sumida-ku, Tokyo, Japan, 130-0004
Status
Location
SOUSEIKAI PS Clinic
Fukuoka, Japan, 812-0025
Status