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    Summary
    EudraCT Number:2021-002387-50
    Sponsor's Protocol Code Number:BNT162-14
    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:2021-06-11
    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 number2021-002387-50
    A.3Full title of the trial
    A Phase II, open-label, rollover trial to evaluate the safety and immunogenicity of one or two boosting doses of Comirnaty or one dose of BNT162b2s01 in
    BNT162-01 trial subjects, or two boosting doses of Comirnaty in BNT162-04 trial subjects
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial testing the safety and effects of two vaccines in healthy adults
    A.3.2Name or abbreviated title of the trial where available
    A trial investigating the safety and effects of one or two additional doses of Comirnaty™ or one dos
    A.4.1Sponsor's protocol code numberBNT162-14
    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 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 pointClinical Operations
    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 number0049613190841204
    B.5.5Fax number004961319084 392010
    B.5.6E-mailBNT162-010414@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 No
    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 nameBNT162b2s01
    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.3.11 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.IMP: 2
    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 Manufacturing GmbH
    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 nameCOMIRNATY (COVID-19 mRNA vaccine (nucleoside-modified)
    D.3.4Pharmaceutical form Concentrate for 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
    Protection against COVID-19
    E.1.1.1Medical condition in easily understood language
    Healthy volunteers and immunocompromised subjects (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
    To determine the safety and tolerability of one or two boosting doses of Comirnaty or one dose of BNT162b2s01 in BNT162-01 trial subjects, or two boosting doses of Comirnaty in BNT162-04 trial subjects.
    E.2.2Secondary objectives of the trial
    To describe changes in SARS-CoV-2 neutralizing antibody titers from baseline to reference and SARS-CoV-2 SA variant (B.1.351)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Have given informed consent by signing the informed consent form (ICF) before initiation of any trial-specific procedures.
    2. 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.
    3. Have received BNT162 vaccine candidates in the BNT162-01 or BNT162-04 trials.
    4. Remain 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 subjects “new baseline” unless required for eligibility (e.g., platelets).
    5. Agree not to enroll in another trial of an IMP, starting after Visit 0 and continuously until Visit 5 (Day 50).
    6. Less than 18 months have passed since their last IMP injection in their parent trial.
    7. 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.
    8. 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.
    9. Have not been diagnosed with SARS-CoV-2 infection in the 12 weeks prior to Day 1 (baseline). Subjects who screen-fail on this criterion may be rescreened.
    10. Platelets = 125,000 to 550,000/mm3.
    11. Chemistry panel: the following apply: alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST) are <3.0 times the upper limit of normal, and/or glomerular filtration rate (GFR) is ≥ 40 mL/min/1.73 m2.
    12. Immunocompromised subjects may be included if their clinical laboratory values are stable in the context of their disease, and if there is no acute deterioration present with the expected need to change their therapy within the 2 weeks after the anticipated trial vaccination.
    13. Women of childbearing potential (WOCBP) must test negative in a urine beta-human chorionic gonadotropin (β-HCG) test at Visits 0 and 1. Women that are post-menopausal or permanently sterilized will be considered as not having reproductive potential.
    14. WOCBP must agree to practice a highly effective form of contraception during the trial, starting at screening and continuously until Visit 5 (Day 50).
    15. WOCBP must confirm that they practiced one highly effective form of contraception for the 14 d prior to screening.
    16. WOCBP must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the trial, starting after Visit 0 and continuously until Visit 5 (Day 50).
    17. Men who are sexually active with a WOCBP and have not had a vasectomy must agree to use a highly effective form of contraception with their female partner of childbearing potential during the trial, starting after Visit 0 and continuously until Visit 5 (Day 50).
    18. Men must be willing to refrain from sperm donation, starting after Visit 0 and continuously until Visit 5 (Day 50).
    E.4Principal exclusion criteria
    1. Have received any SARS-CoV-2 vaccine outside of the BNT162-01 or BNT162-04 trials.
    2. Have a known allergy, hypersensitivity, or intolerance to the planned IMP including any excipients of the IMP.
    3. Have a current febrile illness (body temperature ≥38.0°C) or other acute illness within 48 h prior to Day 1/IMP injection in this trial. Subjects who screen-fail on this criterion may be rescreened.
    4. Have received a live or live attenuated vaccine within 30 d prior to Day 1/IMP injection, or any other vaccination within 14 d prior to Day 1/IMP injection. Subjects who screen-fail on this criterion may be rescreened.
    5. Have an ongoing AE assessed as related to any BNT162-01 or BNT162-04 trial vaccine.
    E.5 End points
    E.5.1Primary end point(s)
    For all Group A and Group B subjects:
    • The proportion of subjects in each treatment group with at least one SAE or the proportion of AESIs occurring up to 26 weeks after the first IMP injection.
    For Group A and a selected subset of Group B subjects:
    • The frequency of solicited local reactions (pain, tenderness, erythema/redness, induration/swelling) at the injection site recorded up to 7 d after each IMP injection.
    • The frequency of solicited systemic reactions (vomiting, diarrhea, headache, fatigue/tiredness, fever, chills, nausea, new or worsened muscle pain, new or worsening joint pain) recorded up to 7 d after each IMP injection.
    For Group A subjects only:
    • The proportion of subjects with at least one unsolicited TEAE or at least one AE related to IMP occurring up to 28 d after IMP injection in each treatment group.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Timepoints are given in the description. See also section 9.4.2 of the study protocol.
    E.5.2Secondary end point(s)
    For Group A and Group B subjects (except transplant subjects):
    • Antibody titers to recombinant S1 and RBD protein derived from reference and SARS-CoV-2 variant B.1.351** will be assessed at baseline (Day 1) and then Day 8, Weeks 3*, 4, 7*, 12, and 26:
    o Neutralizing antibody titers.
    o Antibody titers (ELISA).
    • SARS-CoV-2 functional cross-neutralization of variant B.1.351** to reference strain.
    *Group B only
    **Group A only
    For Group B transplant subjects only:
    • Antibody titers to recombinant S1 and RBD protein derived from SARS-CoV-2 will be assessed at baseline (Day 1) and then Day 8, Weeks 4, 12, and 26 post Dose 1, and at Dose 2 (Day 1) and then Day 8, Weeks 4, 12 and, 26 post Dose 2:
    o Neutralizing antibody titers.
    o Antibody titers (ELISA).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoints are given in the description of the endpoints
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Yes
    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 trial2
    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 concerned5
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    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.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 440
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 109
    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
    healthy adults aged 56 to 85 and immunocompromised subjects aged 18-85
    F.4 Planned number of subjects to be included
    F.4.1In the member state549
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-07-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-09-16
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