A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults
Trial status:Study Complete
Study Identifier:
BNT162-04
ClinicalTrials.gov Identifier:
EudraCT Identifier:
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 1
Sex
Female & Male
Age
18 - 85 Years
Estimated Trial Date
Sep 2020 - Mar 2021
Protocol summary
Originally, the study was planned to include two parts, i.e., Part A and Part B, however Part B was skipped due to changes in the overall clinical development plan. The conducted Part A was a dose-finding part to investigate the optimal dose, allowing dose adjustments upwards and downwards in younger participants. Doses tested in older participants were chosen based on acceptability of dosing in younger participants.
Trial locations
Location
Status
Location
Contract Research Organization
Berlin, Germany
Status
Location
Contract Research Organization
Mannheim, Germany
Status