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    Summary
    EudraCT Number:2026-000221-16
    Sponsor's Protocol Code Number:C4591076
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2026-09-28
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2026-000221-16
    A.3Full title of the trial
    A PHASE 3 PROTOCOL TO INVESTIGATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF BNT162B2 RNA-BASED VARIANT-ADAPTED VACCINE CANDIDATE(S) AGAINST SARS-COV-2 IN PARTICIPANTS 12 THROUGH 64 YEARS OF AGE CONSIDERED AT HIGHER RISK OF SEVERE COVID-19, AND PARTICIPANTS ≥65 YEARS OF AGE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Learn About COVID-19 RNA-Based Variant-Adapted Vaccine Candidate(s) Against SARS-CoV-2 in Participants Ages 12 Through 64 Years Considered at Higher Risk of Severe COVID-19, and Participants Ages ≥65 Years
    A.4.1Sponsor's protocol code numberC4591076
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT07069309
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBioNTech SE
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPfizer
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer
    B.5.2Functional name of contact pointClinical Trials.gov Call Center
    B.5.3 Address:
    B.5.3.1Street Address66 Hudson blvd
    B.5.3.2Town/ cityNew York
    B.5.3.3Post code10001
    B.5.3.4CountryUnited States
    B.5.6E-mailClinicalTrials.gov_Inquiries@Pfizer.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Comirnaty
    D.2.1.1.2Name of the Marketing Authorisation holderBioNTechSE
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Dispersion for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    COVID-19, SARS-COV-2 Infection
    E.1.1.1Medical condition in easily understood language
    COVID-19, SARS-COV-2 Infection
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    -To describe the safety and tolerability profile of BNT162b2 30 μg in participants ≥12 years of age
    -Cohort 1: To describe the immune response to BNT162b2 30 μg and BNT162b2 30 μg in participants ≥18 years of age
    -Cohort 2: To demonstrate that the anti–SARS-CoV-2 immune response after BNT162b2 30 µg compared to before vaccination in
    participants 12through 64 years of age at higher risk of severe COVID-19 meets the predefined immunogenicity threshold
    -Cohort 2: To demonstrate that the anti–SARS-CoV-2 immune response after BNT162b2 30 µg compared to before vaccination in
    participants ≥65 years of age meets the predefined immunogenicity threshold.
    E.2.2Secondary objectives of the trial
    -Cohort 1: To describe the immune response to BNT162b2 30 μg and BNT162b2 30μg in participants ≥18 years of age
    -Cohort 2: To describe the immune response to BNT162b2 30 μg in participants ≥12 years of age
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Cohort 1: Participants 18 years of age or older.
    • Cohort 2: Participants 12 years of age or older.
    • Participants 12 through 64 years of age with at least 1 underlying medical condition that increases their risk of severe COVID-19.

    E.4Principal exclusion criteria
    • History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
    • History of myocarditis or pericarditis.
    • Cohort 2: Receipt of a COVID-19 vaccine or a confirmed case of COVID-19 (confirmed by signs/symptoms and/or a positive test result based on local testing) less than 5 months (150 days) prior to study enrollment.
    E.5 End points
    E.5.1Primary end point(s)
    1. Percentage of participants reporting local reactions
    2. Percentage of participants reporting systemic events
    3. Percentage of participants reporting adverse events
    4. Percentage of participants reporting serious adverse events
    5. Cohort 1: Geometric Mean Titers (GMTs)
    6. Cohort 1: Geometric Mean Fold Rises (GMFRs)
    7. Cohort 1: Percentages of participants with seroresponse
    8. Cohort 2: Geometric Mean Fold Rises (GMFRs)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. For up to 7 days after vaccination
    2. For up to 7 days after vaccination
    3. Through 1 month after vaccination
    4. Through 6 months after vaccination
    5. At 2 weeks after vaccination
    6. From before vaccination to 2 weeks after vaccination
    7. 2 weeks after vaccination
    8. From before vaccination to 1 month after vaccination
    E.5.2Secondary end point(s)
    9. Cohort 1: Geometric Mean Titers (GMTs)
    10. Cohort 1: Geometric Mean Fold Rises (GMFRs)
    11. Cohort 1: Percentages of participants with seroresponse
    12. Cohort 2: Geometric Mean Titers (GMTs)
    13. Cohort 2: Percentages of participants with seroresponse
    E.5.2.1Timepoint(s) of evaluation of this end point
    9. At 1 month after vaccination
    10. From before vaccination to 1 month after vaccination
    11. 1 month after vaccination
    12. From before vaccination to 1 month after vaccination
    13. 1 month after vaccination
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    tolerability and immunogenicity
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last Subject Last Visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days21
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 330
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 330
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 380
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    under the age of 18
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 774
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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