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
Trial ID:
BNT162-14
NCT ID:
NCT04949490
EudraCT ID:
2021-002387-50
EU Trial (CTIS) Number:
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

Results available

Study Protocol
Available Languages: English
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Statistical Analysis Plan
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Trial Details

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.

Medical Condition
  • COVID-19
    • Trial Drug
  • BNT162b2s01
    • See more
  • BNT162b2
    • Phase
    Phase 2
    Type
    Interventional
    Estimated Enrolment
    137
    Estimated Trial Date
    Jul 2021 - Apr 2022

    Trial Participant Requirements

    Age
    18+ years
    Sex
    Female & Male
    Healthy Volunteers
    Yes
    Inclusion and Exclusion Criteria
    Inclusion criteria

      Inclusion Criteria:

    • Had given informed consent by signing the informed consent form (ICF) before initiation of any trial-specific procedures.
    • Were willing and able to comply with scheduled visits, treatment schedule, laboratory tests, lifestyle restrictions (including those requested by the German and federal Governments, e.g., to follow good practices to reduce chances of spreading COVID 19), and other requirements of the trial.
    • Have received BNT162 vaccine candidates in the BNT162-01 or BNT162-04 trials.
    • Remained overall healthy (i.e., has not medically deteriorated significantly since participation in the parent trial, is not anticipated to die in the next 26 weeks, and is able to provide blood as specified by the trial without anticipated, deleterious medical consequences) in the clinical judgment of the investigator based on medical history and physical examination. Screening clinical laboratory tests are to assess the participants' "new baseline" unless required for eligibility. Note: in particular, caution should be used with a subject who has a history of cardiovascular disease, e.g., myocarditis, pericarditis, myocardial infarction, congestive heart failure, cardiomyopathy, or clinically significant arrhythmia.
    • Agreed not to enroll in another trial of an IMP, starting after Visit 0 and continuously until Visit 5 (Day 50).
    • Less than 18 months have passed since their last IMP injection in their parent trial.
    • If they received 30 μg Comirnaty twice in the BNT162-01 trial, Visit 1 in this trial is ≥24 weeks after their last IMP injection, unless the subject is a Cohort 13 transplant subject of the BNT162-01 trial.
    • If they received any other BNT162 vaccine candidate than Comirnaty in the BNT162-01 or BNT162-04 trial or are a Cohort 13 transplant subject, Visit 1 in this trial is ≥12 weeks after their last IMP injection.
    • Have not been diagnosed with SARS-CoV-2 infection in the 12 weeks prior to day 1 (baseline). Participants who screen-fail on this criterion may be rescreened.

      • Exclusion Criteria:

    • Have received any SARS-CoV-2 vaccine outside of the BNT162-01 or BNT162-04 trials.
    • Have had a known allergy, hypersensitivity, or intolerance to the planned IMP including any excipients of the IMP.
    • Have had a current febrile illness (body temperature ≥38.0°C) or other acute illness within 48 hours prior to day 1/IMP injection in this trial. Participants who screen-fail on this criterion may be rescreened.
    • Have received a live or live attenuated vaccine within 30 days prior to day 1/IMP injection, or any other vaccination within 14 days prior to day 1/IMP injection. Participants who screen-fail on this criterion may be rescreened.
    • Have had an ongoing AE assessed as related to any BNT162-01 or BNT162-04 trial vaccine.

    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