A Study to Learn About New COVID-19 RNA Vaccine Candidates in COVID-19 Vaccine-Experienced Healthy Individuals

Trial status:Study Complete
Study Identifier:
C4591044
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

Trial details

Medical Condition
  • COVID-19
  • Study Drug
  • Biological: BNT162b5 Bivalent (WT/OMI BA.2)
  • Biological: BNT162b2 Bivalent (WT/OMI BA.1)
  • Biological: BNT162b2 Bivalent (WT/OMI BA.4/BA.5)
  • See more
  • Biological: BNT162b5 Bivalent (Original/OMI BA.4/BA.5)
  • Biological: BNT162b6 Bivalent (Original/OMI BA.4/BA.5)
  • Biological: BNT162b7 Bivalent (Original/OMI BA.4/BA.5)
  • Biological: BNT162b7 Monovalent (OMI BA.4/BA.5)
  • Phase
    Phase 2
    Sex
    Female & Male
    Age
    12+
    Estimated Trial Date
    Jul 2022 - Mar 2024

    Protocol summary

    The purpose of this clinical trial is to learn about the safety, tolerability and immunogenicity of BNT162b RNA-based SARS-CoV-2 vaccine candidates in adults to prevent COVID-19. For all cohorts (groups of participants), this study is seeking participants who are healthy (who may have preexisting disease if it is stable); All participants will receive a single dose of the study vaccine at the first study clinic and will return to the study clinic at least 4 more times. At each clinic visit, a blood sample will be taken. The study is about 6 months long for each participant. The vaccine candidates in this study are investigational but are very similar to BNT162b2 (Comirnaty), a COVID-19 RNA vaccine approved for use in the US and in many countries. For Cohort 1, this study included participants who were: * 18 through 55 years of age * have received 1 booster dose of a US-authorized COVID-19 vaccine, with the last dose being 90 or more days before Visit 1 of this study. All participants in Cohort 1 will receive 1 of the 2 study vaccines at a 30 microgram dose: BNT162b5 Bivalent (WT/OMI BA.2) or BNT162b2 Bivalent (WT/OMI BA.1). For Cohort 2, this study included participants who were: * 12 years of age and older * have received 3 prior doses of 30 micrograms BNT162b2, with the last dose being 150 to 365 days before Visit 1 of this study. Participants 12 through 17 years of age will receive BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 micrograms. Participants 18 years and older will receive BNT162b2 Bivalent (WT/OMI BA.4/BA.5) at either a 30 microgram or a 60 microgram dose. For Cohort 3, this study included participants who were: * 18 years of age and older * have received 3 prior doses of 30 micrograms BNT162b2, with the last dose being 150 to 365 days before Visit 1 of this study. * Participants will receive BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 micrograms. For Cohort 4, this study is seeking participants who are: * 18 through 55 years of age * have received 3 or 4 prior doses of a US-authorized mRNA COVID-19 vaccine (and dose level), with the last dose being a US-authorized BA.4/BA.5-adapted bivalent vaccine and dose level at least 150 days before Visit 1 of this study. All participants in Cohort 4 will receive 1 of the 5 study vaccines at a 30 microgram dose: BNT162b2 Bivalent (Original/ OMI BA.4/BA.5), BNT162b5 Bivalent (Original/OMI BA.4/BA.5), BNT162b6 Bivalent (Original/OMI BA.4/BA.5), BNT162b7 Bivalent (Original/OMI BA.4/BA.5) or BNT162b7 Monovalent (OMI BA.4/BA.5).

    Trial locations

    Location
    Status
    Location
    Anaheim Clinical Trials, LLC
    Anaheim, California, United States, 92801
    Status
    Location
    California Research Foundation
    San Diego, California, United States, 92123
    Status
    Location
    Bayview Research Group, LLC
    Valley Village, California, United States, 91607
    Status
    Location
    Diablo Clinical Research, Inc.
    Walnut Creek, California, United States, 94598
    Status
    Location
    Clinical Research Consulting
    Milford, Connecticut, United States, 06460
    Status
    Location
    Research Centers of America ( Hollywood )
    Hollywood, Florida, United States, 33024
    Status