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    Summary
    EudraCT Number:2020-006003-42
    Sponsor's Protocol Code Number:ENFORCE
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-12-21
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2020-006003-42
    A.3Full title of the trial
    National Cohort Study of Effectiveness and Safety of SARS-CoV-2 vaccines (ENFORCE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Same as above
    A.3.2Name or abbreviated title of the trial where available
    ENFORCE
    A.4.1Sponsor's protocol code numberENFORCE
    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 SponsorCHIP - Rigshospitalet - University of Copenhagen
    B.1.3.4CountryDenmark
    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 supportSundheds og Ældreministeriet
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHIP - Rigshospitalet, University of Copenhagen
    B.5.2Functional name of contact pointJens Lundgren
    B.5.3 Address:
    B.5.3.1Street AddressBlegdamsvej 9
    B.5.3.2Town/ cityCopenhagen
    B.5.3.3Post code2100
    B.5.3.4CountryDenmark
    B.5.4Telephone number453545 5757
    B.5.5Fax number453647 3340
    B.5.6E-mailjens.lundgren@regionh.dk
    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.2.1.1.1Trade name Pfizer vaccine
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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
    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) No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The aim is to study primarily effectiveness as well as safety of citizens being vaccinated with one of the SARS-CoV2 vaccines being applied in the Danish COVID-19 vaccine programme.
    Whereas ongoing phase III trials are reporting vaccine efficacy in defined study populations, the effectiveness of these vaccines – and in particular the durability hereof - once introduced into the general population is presently unknown, and the focus of intense research and public health interest.


    E.1.1.1Medical condition in easily understood language
    Same as above
    E.1.1.2Therapeutic area Health Care [N] - Environment and Public Health [N06]
    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
    The primary objective of the study is to assess effectiveness of citizens being vaccinated with one of SARS-CoV2 vaccines the government has purchased, and the Danish Medicines Agency has approved for use in Denmark. The study will compare and predict the durability of the minimal protective titre afforded by each of the vaccines against COVID-19 through conducting comprehensive high-throughput SARS-CoV-2 antibody analyses and in-depth characterization of the vaccine-induced cellular immune response
    E.2.2Secondary objectives of the trial
    In relation to effectiveness, the following outcome will be compared between vaccine groups:
    • Breakthrough infections throughout the 24 month follow-up period.
    • A series of more detailed immunological assessment in subgroups of participants of markers of cellular immunity (see appendix 3)

    In relation to safety, the following outcome will be compared between vaccine groups:
    • Participants with local and systemic reactions to vaccination
    • Grade 3 and 4 adverse events and serious adverse events. This will be ascertained and reported by study-affiliated staff. Primary safety outcomes are any grade 3 or 4 (i.e. serious) events observed within the first three months after the initial vaccination.
    • Grade 1 and 2 events. This will be ascertained by study-affiliated staff as present on the specific day of Visit 2 and Visit 3.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Appendix 3 to the protocol:
    Under separate participant informed consent, a cohort will be established including 250 patients (100 healthy and 150 high-risk individuals) from each vaccine group. Live cells (PBMCs) and PAX tubes (for transcriptomic analysis) will be collected for the participants in this cohort. Several work packages or sub-studies will be embedded within this cohort addressing basic and translational research questions requiring additional sampling of biological material as described below.
    Work package 1 (WP1): Immunogenicity: Biobanking of live cells (liquid nitrogen)
    Work package 2 (WP2): Characterization of polyclonal antibody responses to SARS-CoV-2 variants
    Work package 3 (WP3): Characterization of adaptive immune response in individuals with breakthrough infections
    Work package 4 (WP4): Cellular Immunity: Longitudinal immunoprofiling of vaccine responses in SARS CoV-2 vaccinated individuals
    E.3Principal inclusion criteria
    1. Written informed consent obtained before any trial related procedures are performed
    2. Male or female eligible for SARS-CoV-2 immunization (as defined by SST in the national vaccination plan)
    3. The subject must be willing and able to comply with trial protocol (re-visits and biological samples)
    E.4Principal exclusion criteria
    1. Male and female under the age of 18
    2. Any subgroup of individuals for which the vaccines are contra-indicated
    3. Previous SARS-CoV-2 vaccination
    E.5 End points
    E.5.1Primary end point(s)
    Primary outcome is the minimal protective neutralising antibody titre (MPNAT); i.e. the minimum level of neutralising antibodies sufficient to protect the person from becoming infected.


    E.5.1.1Timepoint(s) of evaluation of this end point
    MPNAT will be measured via profiling of antibodies against SARS-CoV-2 Spike epitopes performed at each visit until month 24.

    The exact value of the MPNAT is currently not precisely defined, but is expected to be documented within short periods of time based on analyses across the ongoing phase III trials, associating titre levels with risk of breakthrough infection in the actively vaccinated group.

    As the exact value of the MPNAT remains to be determined, and until that time point has arisen, a priori (i.e. while remaining blinded to the actually obtained data) of the actually defined cut-offs in neutralising titres that reasonable can serve as proxy for the MPNAT will be recommended by an expert advisory panel, and endorsed by the study leadership
    E.5.2Secondary end point(s)
    See under objectives
    E.5.2.1Timepoint(s) of evaluation of this end point
    As above
    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 Yes
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned50
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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: 5000
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5000
    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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10000
    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 Decision2020-12-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-30
    P. End of Trial
    P.End of Trial StatusOngoing
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