A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults

Trial status:Study Complete
Trial ID:
BNT162-04
NCT ID:
NCT04537949
EudraCT ID:
2020-003267-26
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

Trial Details

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.

Medical Condition
  • COVID-19
    • Trial Drug
  • BNT162b3
    • Phase
    Phase 1/Phase 2
    Type
    Interventional
    Estimated Enrolment
    96
    Estimated Trial Date
    Sep 2020 - Mar 2021

    Trial Participant Requirements

    Age
    18 - 85 Years
    Sex
    Female & Male
    Healthy Volunteers
    Yes

    Trial Locations

    Location
    Status
    Location
    Contract Research Organization
    Berlin, Germany
    Status
    Location
    Contract Research Organization
    Mannheim, Germany
    Status