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    Summary
    EudraCT Number:2021-005197-25
    Sponsor's Protocol Code Number:C4591031
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-11-29
    Trial results View 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
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - PEI
    A.2EudraCT number2021-005197-25
    A.3Full title of the trial
    A PHASE 3 MASTER PROTOCOL TO EVALUATE ADDITIONAL DOSE(S) OF BNT162b2 IN HEALTHY INDIVIDUALS PREVIOUSLY VACCINATED WITH BNT162b2
    Ein Phase-III-Gesamtprüfplan zur Beurteilung einer zusätzlichen Dosis (zusätzlicher Dosen) von BNT162B2 bei gesunden Personen, die zuvor mit BNT162B2 geimpft wurden
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate Additional Dose(s) of BNT162b2 in Healthy Individuals Previously Vaccinated With BNT162b2
    A.4.1Sponsor's protocol code numberC4591031
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/179/2021
    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 Inc.
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportBioNTech SE
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBioNTech SE
    B.5.2Functional name of contact pointRegulatory Affairs Strategist
    B.5.3 Address:
    B.5.3.1Street AddressAn der Goldgrube 12
    B.5.3.2Town/ cityMainz
    B.5.3.3Post code55131
    B.5.3.4CountryGermany
    B.5.4Telephone number+49613190847593
    B.5.5Fax number+4961319084390
    B.5.6E-mailregulatory@biontech.de
    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 holderBiontech SE
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.1Product nameBNT162b2
    D.3.2Product code RBP020.2 (PF-07302048)
    D.3.4Pharmaceutical form Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTozinameran
    D.3.9.2Current sponsor codeBNT162b2
    D.3.9.4EV Substance CodeSUB210693
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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) No
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Protection against COVID-19
    E.1.1.1Medical condition in easily understood language
    prevention of infection with the Corona virus
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level PT
    E.1.2Classification code 10051905
    E.1.2Term Coronavirus infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Substudy A
    Please refer to Section 10.7.3 of the protocol

    Substudy B
    Primary Safety
    - To describe the frequency of elevated troponin I levels before and after a booster dose of BNT162b2 or placebo
    - To define the safety profile of a booster dose of BNT162b2

    Substudy C
    Primary Safety
    - To evaluate the safety of a booster dose of BNT162b2 when administered at both 10-μg and 30-μg doses
    Primary Immugeniticy
    - For Primary Immunogenicty objectives of Substudy C, please refer to Protocol Section 10.9.3.

    Substudy D
    Please refer to Section 10.10.3 of the protocol.

    Substudy E
    Please refer to Section 10.11.3 of the protocol

    Substudy F
    Please refer to Section 10.12.3. of the protocol
    E.2.2Secondary objectives of the trial
    Substudy A
    Please refer to Section 10.7.3. of the protocol.

    Substudy B
    - Not available on the Protocol

    Substudy C
    Secondary Immunogenicity
    - To describe the immune responses induced by a booster (third) dose of BNT162b2 at 10 μg and 30 μg

    Substudy D
    Please refer to Section 10.10.3. of the protocol

    Substudy E
    Please refer to Section 10.11.3 of the protocol

    Substudy F
    PLease refer to Section 10.12.3 of the protocol
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    SUBSTUDY A, B, C, D, E, F - Protocol Amendment 11, 20 Sep 2022

    Substudy A
    This is a Phase 3 randomized, placebo-controlled, observer-blind
    substudy to evaluate the safety, tolerability, and efficacy of a booster
    dose of BNT162b2. Participants ≥16 years of age who have completed a 2-dose primary series of BNT162b2 at least 6 months prior to randomization will be enrolled, and participants will be randomized at a ratio of 1:1 to receive either BNT162b2 or placebo.(Number or treatment arms:2)

    Substudy B
    This is a randomized, placebo-controlled, observer-blind, crossover
    substudy to evaluate the safety and tolerability of a booster (third or fourth) dose of BNT162b2. Participants ≥12 years of age to ≤30 years of age who have receiveda 2 or 3 doses of BNT162b2 (30-μg doses) with their last dose at least 4 months (120 days) prior to randomization will be enrolled.
    (Number of treatment arms: 2)

    Substudy C
    This is a randomized, observer-blinded substudy to evaluate the safety, tolerability, and immunogenicity of a booster (third) dose of BNT162b2 at 10 μg and at 30 μg. Participants ≥12 years of age who have completed a 2-dose primary series of BNT162b2 (30 μg doses) at least 5 months (150 days) prior to randomization will be enrolled.
    (Number of treatment arms: 2)

    SUBSTUDY D
    This is a randomized substudy composed of open-labeled and observerblinded groups to evaluate the safety, tolerability, and immunogenicity of a 2-dose primary series of BNT162b2 OMI, and as a booster (third or fourth or fifth) dose at investigator sites in the US and South Africa only.
    Participants ≥18 years of age to ≤55 years of age will be enrolled.
    (Number of treatment arms: 6)

    SUBSTUDY E
    This is a randomized, observer-blinded substudy to evaluate the safety, tolerability, and immunogenicity of high-dose BNT162b2 (60 μg), highdose BNT162b2 OMI (60 μg), and a high-dose combination of BNT162b2 and BNT162b2 OMI at 60 μg (30 μg each), given as a single dose).
    Approximately 1920 participants above 55 years of age and 990 participants 18 to 55 years of age who have
    received 3 prior doses of BNT162b2 (30-μg doses) with the most recent dose being 5 to 12 months (150 to 360 days) prior to randomization, will be enrolled at investigator sites in the US only.
    (Number of treatment arms: 6)

    SUBSTUDY F
    This is a randomized, observer-blinded sub study to describe the safety, tolerability, and immunogenicity of high-dose BNT162b2 (60 μg), highdose BNT162b2 OMI (60 μg), and a high-dose combination of BNT162b2 and BNT162b2 OMI at 60 μg (30 μg each), given as a single dose.
    Approximately 180 participants ≥ 60 years of age who have received 3 prior doses of BNT162b2 (30 μg doses), with the most recent dose being ≥4 months prior to randomization, will be enrolled in Israel.
    (Number of treatment arms: 6)

    For substudy-specific objectives and endpoints, please refer to each
    respective substudy appendix of the protocol and E.2.1, E.2.2 and E.5 of the Form.
    E.3Principal inclusion criteria
    Participants are eligible to be included in the study only if all of the
    substudy-specific inclusion criteria are met.
    For Substudy A, see Section 10.7.5.1. of the Study Protocol.
    For Substudy B, see Section 10.8.5.1. of the Study Protocol.
    For Substudy C, see Section 10.9.5.1. of the Study Protocol.
    For Substudy D, see Section 10.10.5.1. of the Study Protocol.
    For Substudy E, see Section 10.11.5.1. of the Study Protocol.
    For Substudy F, see Section 10.12.5.1. of the Study Protocol.

    Some inclusion criteria are common to all substudies: participants (and their parent(s)/legal guardian(s) willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle
    considerations, and other study procedures; participants should be
    healthy; and participants (or their parent[s]/legal guardian[s]) must be capable of giving personal signed informed consent.
    E.4Principal exclusion criteria
    Participants are excluded from the study if any of the substudy-specific exclusion criteria apply.
    Some exclusion criteria are common to all substudies: participants with medical or psychiatric conditions that may increase the risk of study participation; history of severe adverse reactions associated with a vaccine and/or severe allergic reaction to any component of the study vaccination; previous clinical or microbiological diagnosis of COVID-19; immunocompromised individuals; or participants with bleeding diathesis.
    For Substudy A, see Section 10.7.5.2. of the Study Protocol.
    For Substudy B, see Section 10.8.5.2. of the Study Protocol.
    For Substudy C, see Section 10.9.5.2. of the Study Protocol.
    For Substudy D, see Section 10.10.5.2. of the Study Protocol.
    For Substudy E, see Section 10.11.5.2. of the Study Protocol.
    For Substudy F, see Section 10.12.5.2. of the Study Protocol.
    E.5 End points
    E.5.1Primary end point(s)
    Substudy A
    - Please refer to Section 10.7.3. of the Protocol.

    Substudy B
    Primary Safety
    - Troponin I level
    - Local reactions (pain at the injection site, redness, and swelling)
    - Systemic events (fever, fatigue/tiredness, headache, chills, vomiting,
    diarrhea, new or worsened muscle pain, and new or worsened joint
    pain)
    - AEs
    - SAEs

    Substudy C
    Primary Efficacy
    - Local reactions (pain at the injection site, redness, and swelling)
    - Systemic events (fever, fatigue/tiredness, headache, chills, vomiting,
    diarrhea, new or worsened muscle pain, and new or worsened joint
    pain)
    - AEs
    - SAEs
    Primary Immunogenicity
    - SARS-CoV-2 reference-strain neutralizing titers

    Substudy D:
    - Please refer to Section 10.10.3 of the Protocol.

    Substudy E
    - Please refer to Section 10.11.3. of the protocol.

    Substudy F
    - Please refer to Section 10.12.3. of the protocol.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Please, see Protocol Section 3, Section 10.7.3; Section 10.8.3; Section
    10.9.3; Section 10.10.3; Section 10.11.3 and Section 10.12.3.
    E.5.2Secondary end point(s)
    Substudy A
    - Please refer to Section 10.7.3. of the Protocol.

    Substudy B
    Not applicable.

    Substudy C
    Secondary Immunogenicity
    - SARS-CoV-2 reference-strain neutralizing titers
    SARS-CoV-2 Omicron BA.1 neutraliting titers

    Substudy D:
    - Please refer to Section 10.10.3 of the Protocol.

    Substudy E
    - Please refer to Section 10.11.3. of the protocol.

    Substudy F
    - Please refer to Section 10.12.3. of the protocol.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please, see Protocol Section 3, Section 10.7.3; Section 10.8.3 and Section 10.9.3. Section 10.10.3; Section 10.11.3 and Section 10.12.3.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial24
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Brazil
    Israel
    South Africa
    United States
    Germany
    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
    The end of the (sub)study is defined as the date of the last visit of the last participant in the (sub)study.

    A participant is considered to have completed the (sub)study if he/she has completed all phases of the (sub)study, including the last visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days0
    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: 1190
    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: 720
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 12295
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3755
    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 No
    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 Yes
    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 No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Children between 12-17 years old
    F.4 Planned number of subjects to be included
    F.4.1In the member state51
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 51
    F.4.2.2In the whole clinical trial 16390
    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)
    No intervention will be provided to study participants at the end of their study participation.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-02-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-02-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-11-03
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