A Trial Investigating the Safety and Effects of One or Two Additional Doses of Comirnaty or One Dose of BNT162b2s01 in BNT162-01 or BNT162-04 Trial Subjects

Trial status:Study Complete
Study Identifier:
BNT162-14
ClinicalTrials.gov Identifier:
NCT04949490
EudraCT Identifier:
2021-002387-50
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
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Statistical Analysis Plan
Available Language(s): English
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Trial details

Medical Condition
  • COVID-19
    • Study Drug
  • Biological: BNT162b2s01
  • Biological: BNT162b2
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18+
    Estimated Trial Date
    Jul 2021 - Apr 2022

    Protocol summary

    Trial to evaluate the safety and immunogenicity of one or two boosting doses of Comirnaty or one dose of BNT162b2s01 (Variant of concern \[VOC\] strain B.1.351) in BNT162-01 trial participants, or two boosting doses of Comirnaty in BNT162-04 trial participants. Trial participants from BNT162-01 who received two injections of 30 μg Comirnaty were randomized 2:1 to one booster injection (BNT162b2s01: Comirnaty). Trial participants in either the trial BNT162-01 or BNT162-04 who did not receive the full two vaccinations of 30 μg Comirnaty were offered two injections of 30 μg Comirnaty as per the conditional marketing authorization. All potential rollover volunteers must enroll in this trial within less than 18 months of their last injection of a BNT162 candidate vaccine in the parent BNT162-01 or BNT162-04 trials.

    Trial locations

    Location
    Status
    Location
    CRS Clinical Research Services Berlin GmbH
    Berlin, Germany, 13353
    Status
    Location
    University Hospital Frankfurt, Infectiology
    Frankfurt, Germany, 60590
    Status
    Location
    University Hospital Heidelberg, Clinical Pharmacology
    Heidelberg, Germany, 69117
    Status
    Location
    CRS Clinical Research Services Mannheim GmbH
    Mannheim, Germany, 68167
    Status