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    The EU Clinical Trials Register currently displays   42564   clinical trials with a EudraCT protocol, of which   7007   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


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    Summary
    EudraCT Number:2021-005043-71
    Sponsor's Protocol Code Number:EU-COVPT-1
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Not Authorised
    Date on which this record was first entered in the EudraCT database:2022-02-10
    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 ConcernedNorway - NOMA
    A.2EudraCT number2021-005043-71
    A.3Full title of the trial
    A Phase 2, Comparative Randomised Trial to Evaluate the impact of
    reduced COVID-19 mRNA vaccination regimen on immunological
    responses and reactogenicity in paediatric subjects withprior SARS-CoV-2 immunity
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical Study Evaluating the immune responses and safety of single versus two dose COVID-19 mRNA Vaccination in children (CoVacc)
    A.3.2Name or abbreviated title of the trial where available
    Immunogenicity and reactogenicity of reduced COVID-19 mRNA vaccination regimen in children (CoVacc)
    A.4.1Sponsor's protocol code numberEU-COVPT-1
    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 SponsorUniversity Medical Center Utrecht
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportHorizon 2020
    B.4.2CountryEuropean Union
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center Utrecht
    B.5.2Functional name of contact pointEUPG, CoVacc Study Team
    B.5.3 Address:
    B.5.3.1Street AddressHeidelberglaan 100
    B.5.3.2Town/ cityUtrecht
    B.5.3.3Post code3584 CX
    B.5.3.4CountryNetherlands
    B.5.6E-mailcovacc@umcutrecht.nl
    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 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.3.4Pharmaceutical form Concentrate for dispersion for injection
    D.3.4.1Specific paediatric formulation Yes
    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
    Healthy volunteers (paediatric subjects) with prior SARS-CoV-2 infection
    E.1.1.1Medical condition in easily understood language
    Healthy children with prior COVID-19 infection
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level LLT
    E.1.2Classification code 10084464
    E.1.2Term COVID-19 immunization
    E.1.2System Organ Class 100000004865
    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 if the humoral immune response of a single compared to a two dose COVID‐19 vaccination regimen is non‐inferior in paediatric subjects who are immunologically primed by natural infection.
    E.2.2Secondary objectives of the trial
    1. To assess the safety and reactogenicity profile of a single dose COVID‐19 vaccine regimen
    against SARS‐CoV‐2 in paediatric subjects with a history of prior SARS‐CoV‐2 infection,
    compared to the two dose regimen.
    2. To assess the medium (6 months) and long term (12 month) humoral immune response of
    the single COVID‐19 vaccine dosing regimen against wild‐type SARS‐CoV‐2 in paediatric
    subjects with a history of prior SARS‐CoV‐2 infection.
    3. To assess the short (28 days), medium and long term humoral immune response of the single
    dose COVID‐19 vaccine regimen against SARS‐CoV‐2 variants of concern (VoCs) in paediatric subjects with a history of prior SARS‐CoV‐2 infection.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. 5 up to and including 11 years of age on day of signing the informed consent form.
    2. In good health or stable clinical condition.
    3. Has documented evidence of a previous SARS-CoV-2 infection or presence of SARS-CoV-2 specific serum antibodies.
    4. Legally Accepted Representative (LAR) has reviewed the subject information and signed the informed consent form on behalf of the subject.
    E.4Principal exclusion criteria
    1. Has previously received any investigational or licensed COVID‐19 vaccine.
    2. Has known congenital or acquired immune disorder or immunodeficiency that may interfere
    with vaccine response e.g. known infection with human immunodeficiency virus (HIV) with
    low CD4 count or other immunosuppression at time of signing informed consent form.
    3. Has a history of autoimmune disease or an active autoimmune disease requiring therapeutic
    intervention (including systemic glucocorticoids), or findings that may have a significant
    effect on the target endpoints and which may therefore mask or inhibit the therapeutic
    effect under investigation as judged by the investigator.
    4. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection or venepuncture.
    5. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction
    (eg, anaphylaxis) to any component of the study intervention(s).
    6. Receipt of medications intended to prevent COVID‐19.
    7. Uses drugs with significant interaction with the investigational product or has any
    contraindications as per the Summary of Product Characteristics.
    8. Other medical or psychiatric condition or laboratory abnormality that may increase the risk
    of study participation or, in the investigator’s judgment, make the participant inappropriate
    for the study.
    9. Has any kind of dependency on the principal investigator or member of the study team or LAR is employed by the sponsor or principal investigator.
    10. Is unable to report solicited adverse events.
    E.5 End points
    E.5.1Primary end point(s)
    The geometric mean ratio of neutralizing
    titers against wild type virus (Virus Neutralization Assay) at day 28 after completion of the control
    versus the intervention regimen of the vaccine.
    E.5.1.1Timepoint(s) of evaluation of this end point
    as specified in the endpoints
    E.5.2Secondary end point(s)
    Safety:
    - The percentage of subjects reporting at least one solicited systemic adverse events Grade ≥ 2 (AEs) in the 7 days after any vaccine dose, as measure of systemic reactogenicity.
    - The percentage of subjects reporting solicited local and systemic adverse events (AEs) for 7 days
    after each vaccine dose.
    - The percentage of subjects reporting unsolicited AEs for 14 days after each vaccine dose.
    - The percentage of subjects reporting serious adverse events (SAEs) Grade >3 on the Common
    Toxicity Criteria or Adverse Events of Special interest (AESI) until 12 months post‐vaccination.

    Immunogenicity:
    - Neutralizing titers against wild type virus (Virus Neutralization Assay) at 6 and 12 months postvaccination.
    - Quantitative enzyme‐linked immunosorbent assay (anti‐RBD‐ELISA) at 28 days, 6 months and 12
    months post‐vaccination.
    - Geometric Mean Fold Ratio in SARS‐CoV‐2 serum anti‐RBD antibody titer from before vaccination
    to each subsequent time points at 1, 6 and 12 months post‐vaccination.
    - Neutralizing titers against variants of concern (Virus Neutralization Assay) at day 28 and 6 months
    post‐vaccination.
    E.5.2.1Timepoint(s) of evaluation of this end point
    as specified in the endpoints
    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 Yes
    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) 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 Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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 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
    LVLS
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 200
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 200
    F.1.1.6Adolescents (12-17 years) No
    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 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
    Children 5 to 11 years of age
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 200
    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)
    If the study results at completion of the clinical trial show that the humoral immune response of a single dose COVID-19 vaccination in subjects assigned to the single dose intervention arm is insufficient, it will be considered to offer those subjects an additional vaccination following local practices and regulations.
    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 Decision2022-03-14
    N.Ethics Committee Opinion of the trial applicationNot-Favourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-03-29
    P. End of Trial
    P.End of Trial StatusNot Authorised
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