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    Summary
    EudraCT Number:2022-001590-31
    Sponsor's Protocol Code Number:22/01611
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-10-03
    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 number2022-001590-31
    A.3Full title of the trial
    A parallel group, prevention, phase iv, unblinded 2-arm study to investigate hospital admission and deaths due to COVID-19, after receiving an invitation to take a second booster COVID-19 vaccine compared with not receiving an invitation in participants 45 to 64 years of age without any COVID-19 risk factors, who have received 3 doses of a COVID-19 vaccine and with the last dose administered at least 4 months ago.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate the risk of severeo COVID-19 after receiving an invitation to take a second booster COVID-19 vaccine compared with not receiving an invitation in participants 45 to 64 years of age without any COVID-19 risk factors, who have received 3 doses of a COVID-19 vaccine with last dose administered at least 4 months ago.
    A.4.1Sponsor's protocol code number22/01611
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05539703
    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 SponsorNorwegian Institute of Public Health
    B.1.3.4CountryNorway
    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 supportNorwegian Institute of Public Health
    B.4.2CountryNorway
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNorwegian Institute of Public Health
    B.5.2Functional name of contact pointResearch Director
    B.5.3 Address:
    B.5.3.1Street AddressPO Box 222 Skøyen
    B.5.3.2Town/ cityOslo
    B.5.3.3Post code0213
    B.5.3.4CountryNorway
    B.5.5Fax numberNorwa91649828
    B.5.6E-mailatle.fretheim@fhi.no
    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 Any type of COVID-19 vaccine offered as 2nd booster within the public vaccine program, including: - Comirnaty Original/Omicron BA.1 (or Omicron BA.4-5) (Pfizer) - Spikevax bivalent Original/Omicron BA.1 (Moderna)
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer / Moderna
    D.2.1.2Country which granted the Marketing AuthorisationNorway
    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 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 Yes
    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
    COVID-19.
    E.1.1.1Medical condition in easily understood language
    COVID-19
    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
    To investigate whether receiving an invitation to take a second booster COVID-19 vaccine redcudes the risk of hospital admissions and/or death due to COVID-19, compared with not receiving an invitation, in participants 45 to 64 years of age without any COVID-19 risk factors, who have received 3 doses of a COVID-19 vaccine with last dose administered at least 4 months ago.
    E.2.2Secondary objectives of the trial
    To determine the effects (intended and unintended) of offering vaccination with a COVID-19 booster dose on the use of health care services, and on SARS-CoV-2 infection rate.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Aged between 45 and 64 years
    - Registered in the Norwegian national population register
    - Have received three doses of a COVID-19 vaccine, with the last dose received at least four months ago.
    - Have not previously been offered or recommended a 4th dose for medical reasons
    E.4Principal exclusion criteria
    - Persons who have already been offered a 4th COVID-19 vaccine dose.
    - Persons in whom COVID-19 vaccination is contraindicated as per the vaccines’ Summary of Product Characteristics (SPC).
    E.5 End points
    E.5.1Primary end point(s)
    Hospitalization or death caused by COVID-19 starting on day 22 after the invitation is sent to the intervention group.
    E.5.1.1Timepoint(s) of evaluation of this end point
    We aim for 20 week follow up, but the length of follow-up may be adjusted depending on the the number of hospitalizations.
    E.5.2Secondary end point(s)
    - Hospitalization or death from all causes
    - Health care utilization and use of prescription medication related to COVID-19
    - Registered COVID-19 infection
    - Health care utilization related to potential side effects of the COVID-19 vaccine (e.g., myocarditis)
    - Infection, hospitalization or death in a period of 12 months starting from the date of receiving the 1st booster dose
    E.5.2.1Timepoint(s) of evaluation of this end point
    20 weeks (and 12 months)
    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 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 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 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 Yes
    E.8.2.3.1Comparator description
    No invitation to receive the 2nd booster vaccination.
    E.8.2.4Number of treatment arms in the trial1
    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 concerned150
    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
    End of trial is defined by the time past since the last participation received the invitation to take the 2nd booster dose (as per the definitions of the various outcomes - see above).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months3
    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: 800000
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2022-10-03. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    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 state800000
    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 different from other post-vaccination follow up within national vaccination program.
    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 Decision2022-10-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-09-01
    P. End of Trial
    P.End of Trial StatusOngoing
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