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    Summary
    EudraCT Number:2020-005442-42
    Sponsor's Protocol Code Number:C4591007
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-08-11
    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
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2020-005442-42
    A.3Full title of the trial
    A PHASE 1, OPEN-LABEL DOSE-FINDING STUDY TO EVALUATE SAFETY, TOLERABILITY, AND IMMUNOGENICITY AND PHASE 2/3 PLACEBOCONTROLLED, OBSERVER-BLINDED SAFETY, TOLERABILITY, AND IMMUNOGENICITY STUDY OF A SARS-COV-2 RNA VACCINE CANDIDATE AGAINST COVID-19 IN HEALTHY CHILDREN AND YOUNG ADULTS
    BADANIE OTWARTE FAZY I NAD OKREŚLENIEM DAWKI, MAJĄCE NA CELU OCENĘ BEZPIECZEŃSTWA, TOLERANCJI I IMMUNOGENNOŚCI ORAZ ZAŚLEPIONE DLA OBSERWATORA BADANIE FAZY II/III Z GRUPĄ KONTROLNĄ OTRZYMUJĄCĄ PLACEBO, MAJĄCE NA CELU OKREŚLENIE BEZPIECZEŃSTWA, TOLERANCJI I IMMUNOGENNOŚCI KANDYDATA NA SZCZEPIONKĘ RNA SARS-COV-2 PRZECIWKO COVID-19 U ZDROWYCH DZIECI MŁODYCH OSÓB DOROSŁYCH
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Children and Young Adults
    Badanie fazy I/II/III, oceniające bezpieczeństwo, tolerancję i immunogenność kandydata na szczepionkę RNA przeciwko COVID-19 u zdrowych dzieci młodych osób dorosłych
    A.4.1Sponsor's protocol code numberC4591007
    A.7Trial is part of a Paediatric Investigation Plan Yes
    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 Inc.
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportBioNTech
    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-mailRuben.Rizzi@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 INNNAP
    D.3.9.2Current sponsor codeBNT162b2
    D.3.9.3Other descriptive nameTozinameran
    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
    Phase 1:
    -To describe the safety and tolerability profiles of prophylactic BNT162b2 at each dose level in each age group.

    Phase 2/3: Primary Safety:
    - To define the safety profile of prophylactic BNT162b2 in all participants (selected-dose, lower-dose, and obtaining-serum-samples-for potential troponin I- testing portions of the study) in Phase 2/3 in each age group

    Primary Immunogenicity (Selected dose 2-Dose series):
    - To immunobridge the immune response elicited by prophylactic BNT162b2 between Ph 2/3 participants at the dose selected in each age group and participants 16 to 25 years of age from the C4591001 study without serological or virological evidence (up to 1 month after receipt of Dose 2) of past SARS-CoV-2 infection
    (For age groups, please refer to the protocol.)

    Primary Immunogenicity (Selected-Dose 3-Dose Series)
    (For further objectives, please refer to the Protocol.)
    E.2.2Secondary objectives of the trial
    Phase 1:
    - To describe the immune responses elicited by prophylactic BNT162b2 at each dose level in each age group

    Phase 2/3:
    Secondary Immunogenicity (Lower-Dose Evaluation):
    - To immunobridge the immune response elicited by prophylactic BNT162b2 between Phase 2/3 participants at the lower dose schedule selected in each age group and participants from the C4591001 study without serological or virological evidence (up to 1 month after receipt of Dose 2) of past SARS-CoV-2 infection. (For age groups, please refer to the protocol.)

    Secondary Immunogenicity/Efficacy:
    - To describe the immune responses elicited by prophylactic BNT162b2 at the dose level selected in each age group and persistence of immune response in Phase 2/3 participants without serological or virological evidence of past SARS-CoV-2 infection
    - For further secondary endpoints, please refer to the protocol.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age and Sex:
    1. Male or female participants between ≥6 months and <12 years of age, at the time of randomization, at Visit 1 for the dose finding/selecteddose evaluation and between ≥5 and <30 years of age, at the time of randomization, at Visit 1 for the lower-dose evaluation.
    For the obtaining-serum samples-for-potential-troponin I testing portion of the study:
    • Male or female participants between ≥5 and <16 years of age.
    • Refer to Appendix 4 for reproductive criteria for male (Section 10.4.1) and female (Section 10.4.2) participants.

    Type of Participant and Disease Characteristics:
    2. Participants’ parent(s)/legal guardian(s) and participants, as age appropriate, who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
    3. Healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study.
    Note: Healthy participants with preexisting stable disease, defined as disease not requiring significant change in the therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included.
    Phase 2/3: Specific criteria for such participants with known stable infection with HIV, HCV, or HBV can be found in Section 10.7.
    4. Participants are expected to be available for the duration of the study and whose parent(s)/legal guardian can be contacted by telephone during study participation.
    5. Negative urine pregnancy test for female participants who are biologically capable of having children.
    6. Female participant of childbearing potential or male participant able to father children who is willing to use a highly effective method of contraception as outlined in this protocol for at least 28 days after the last dose of study intervention if at risk of pregnancy with her/his partner; or female participant not of childbearing potential or male participant not able to father children.
    Informed Consent:
    7. The participant or participant’s parent(s)/legal guardian is capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol. Depending on the age of the participant and according to local requirements, participants will also be asked to provide assent as appropriate (verbal or written).
    The investigator, or a person designated by the investigator, will obtain written or electronically signed informed consent (and assent) from each study participant or participant’s legal guardian (as defined in Appendix 1) and the participant’s assent, when applicable, before any study-specific activity is performed. All legal guardians should be fully informed, and participants should be informed to the fullest extent possible, about the study in language and terms they are able to understand. The investigator will retain the original copy of each participant's signed consent/assent document.
    E.4Principal exclusion criteria
    Medical Conditions:
    1. Phase 1 only: Past clinical (based on COVID-19 symptoms/signs alone, if a SARS CoV 2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID 19.
    2. Phase 1 only: Known infection with HIV, HCV, or HBV.
    3. Receipt of medications intended to prevent COVID-19.
    4. Previous or current diagnosis of MIS-C.
    5. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. Note: This includes both conditions that may increase the risk associated with study intervention administration or a condition that may interfere with the interpretation of study results
    6. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
    7. Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
    8. Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention, including but not limited to systemic lupus erythematosus. Note: Stable type 1 diabetes and hypothyroidism are permitted.
    9. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
    10. Female who is pregnant or breastfeeding.
    Prior/Concomitant Therapy:
    11. Previous vaccination with any coronavirus vaccine.
    12. Individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study. If systemic corticosteroids have been administered short term (<14 days) for treatment of an acute illness, participants should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 28 days before study intervention administration. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
    13. Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study intervention administration, or receipt of any passive antibody therapy specific to COVID-19 from 90 days before study intervention administration, or planned receipt throughout the study.
    Prior/Concurrent Clinical Study Experience:
    14. Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation.
    15. Previous participation in other studies involving study intervention containing LNPs.
    Diagnostic Assessments:
    Not applicable.
    Other Exclusions:
    16. Participants who are direct descendants (child or grandchild) of investigational site staff members or Pfizer/BioNTech employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
    E.5 End points
    E.5.1Primary end point(s)
    Phase 1:
    • Participants ≥16 to <18, ≥12 to <16, ≥5 to <12 years and ≥2 to <5 years of age:
    • Local reactions (pain at the injection site, redness, and swelling)
    • Systemic events (fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain)
    • AEs
    • SAEs

    Participants ≥6 months to <2 years of age:
    • Local reactions (tenderness at the injection site, redness, and swelling)
    • Systemic events (fever, decreased appetite, drowsiness, and irritability)
    • AEs
    • SAEs

    Phase 2/3
    Primary Safety:
    Participants ≥16 to <18, ≥12 to <16, ≥5 to <12 years and ≥2 to <5 years of age:
    • Local reactions (pain at the injection site, redness, and swelling)
    • Systemic events (fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain)
    • AEs
    • SAEs

    Participants ≥6 months to <2 years of age:
    • Local reactions (tenderness at the injection site, redness, and swelling)
    • Systemic events (fever, decreased appetite, drowsiness, and irritability)
    • AEs
    • SAEs
    Primary Immunogenicity (Selected dose 2-Dose Series):
    •SARS-CoV-2 neutralizing titers

    Primary Immunogenicity (Selected-Dose 3-Dose Series):
    SARS-CoV-2 neutralizing titers
    E.5.1.1Timepoint(s) of evaluation of this end point
    Please see the clinical study protocol Section 3
    E.5.2Secondary end point(s)
    Phase 1:
    • SARS CoV 2 neutralizing titers

    Phase 2/3:
    Secondary Immunogenicity (Lower Dose Evaluation):
    - SARS-CoV-2 neutralizing titers

    Secondary Immunogenicity/Efficacy:
    - SARS-CoV-2 neutralizing titers

    Secondary Efficacy (Selected-Dose 2-Dose Series):
    - Confirmed COVID-19 incidence from 7 days after Dose 2 to prior to Dose 3 per 1000 person-years of blinded follow-up
    - Incidence of asymptomatic infection of SARS-CoV-2 based on N-binding antibody seroconversion

    Secondary Efficacy (Selected-Dose 3-Dose Series):
    Confirmed COVID-19 incidence from 7 days after Dose 3 per 1000 person-years of blinded follow-up
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please see the clinical study protocol Section 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 No
    E.6.5Efficacy No
    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 No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, and Immunogenicity
    E.7.2Therapeutic exploratory (Phase II) Yes
    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 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 Yes
    E.8.1.7.1Other trial design description
    OBSERVER-BLINDED
    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 trial4
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    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
    Argentina
    Brazil
    Mexico
    United States
    Finland
    Poland
    Spain
    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
    A participant is considered to have completed the study if he/she has completed all phases of the study, including the last visit.
    The end of the study is defined as the date of the last visit of the last participant in the study.
    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 months3
    E.8.9.1In the Member State concerned days27
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days7
    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: 15590
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 4516
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 9846
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 1228
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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
    minors <18 years of age
    F.4 Planned number of subjects to be included
    F.4.1In the member state1035
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 3088
    F.4.2.2In the whole clinical trial 15590
    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 the study.
    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 Decision2021-04-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-12-08
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