Safety and Immunogenicity of RNA-based Vaccines Against SARS-CoV-2 Variants in Healthy Participants

Trial status:Study Complete
Trial ID:
BNT162-17
NCT ID:
NCT05004181
EudraCT ID:
2021-003458-22
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

This trial consisted of three parts, Part A, Part B, and Part C, and evaluated the safety and immunogenicity of a third (booster) injection of the multivalent vaccine BNT162b2 (B.1.1.7 + B.1.617.2), and the safety and immunogenicity of a third booster injection of the monovalent vaccine BNT162b2 (B.1.617.2) or BNT162b2 (B.1.1.7), in participants who had received two doses of the parent vaccine BNT162b2 at 30 µg, at least 6 months after the second dose of BNT162b2. It also evaluated the safety and immunogenicity of a three-dose regimen of BNT162b2 (B.1.1.7 + B.1.617.2) in participants who had not received prior Coronavirus Disease 2019 (COVID-19) vaccination. In addition, the safety and immunogenicity of BNT162b2 (B.1.1.529.1) or BNT162b2 given as a third or fourth vaccine dose to RNA COVID-19 vaccine-experienced participants with history of SARS-CoV-2 Omicron variant infection was evaluated and contrasted with the natural immune response reached after infection with the SARS-CoV-2 Omicron variant in RNA COVID-19 vaccine-experienced participants.

Medical Condition
  • COVID-19
    • Trial Drug
  • BNT162b2
    • See more
  • Multivalent BNT162b2 (B.1.1.7 + B.1.617.2)
  • Monovalent BNT162b2 (B.1.1.7)
  • Monovalent BNT162b2 (B.1.617.2)
  • Monovalent BNT162b2 (B.1.1.529.1)
    • Phase
    Phase 2
    Type
    Interventional
    Estimated Enrolment
    1380
    Estimated Trial Date
    Aug 2021 - Aug 2023

    Trial Participant Requirements

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

    Trial Locations

    Location
    Status
    Location
    Collaborative Neuroscience Network LLC
    Long Beach, California, United States, 90806
    Status
    Location
    California Research Foundation
    San Diego, California, United States, 92123
    Status
    Location
    Clinical Research Consulting, Llc
    Milford, Connecticut, United States, 06460
    Status
    Location
    Stamford Therapeutics Consortium
    Stamford, Connecticut, United States, 06905
    Status
    Location
    Atlanta Center for Medical Research
    Atlanta, Georgia, United States, 30331
    Status
    Location
    Meridian Clinical Research
    Savannah, Georgia, United States, 31406
    Status