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    Summary
    EudraCT Number:2021-003170-31
    Sponsor's Protocol Code Number:QHD00027
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-06-10
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2021-003170-31
    A.3Full title of the trial
    Feasibility of Randomizing Danish Citizens Aged 65-79 Years to High-Dose Quadrivalent Influenza Vaccine vs. Standard-Dose Quadrivalent Influenza Vaccine in a Pragmatic Registry-Based Setting
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Feasibility of Conducting a Study Comparing High-Dose Influenza Vaccines to Standard-Dose Influenza Vaccines in Danish Citizens Aged 65-79 Years
    A.4.1Sponsor's protocol code numberQHD00027
    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 SponsorCardiovascular Non-Invasive Imaging Research Laboratory, Department of Cardiology, Herlev and Gentofte Hospital
    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 supportSanofi Pasteur
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCardiovascular Non-Invasive Imaging Research Laboratory, Department of Cardiology, Herlev and Gentofte Hospital
    B.5.2Functional name of contact pointNiklas Dyrby Johansen
    B.5.3 Address:
    B.5.3.1Street AddressGentofte Hospitalsvej 8, 3.th.
    B.5.3.2Town/ cityHellerup
    B.5.3.3Post code2900
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4520204794
    B.5.6E-mailniklas.dyrby.johansen@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 Yes
    D.2.1.1.1Trade name Efluelda®
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pasteur
    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.3.1Product nameHigh-Dose Quadrivalent Influenza Vaccine
    D.3.4Pharmaceutical form Suspension for injection in pre-filled syringe
    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 INNINFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)
    D.3.9.3Other descriptive nameA/H1N1-like strain
    D.3.9.4EV Substance CodeSUB12066MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number60
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)
    D.3.9.3Other descriptive nameA/H3N2-like strain
    D.3.9.4EV Substance CodeSUB12066MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number60
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)
    D.3.9.3Other descriptive nameB/Victoria Lineage
    D.3.9.4EV Substance CodeSUB12066MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number60
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)
    D.3.9.3Other descriptive nameB/Yamagata Lineage
    D.3.9.4EV Substance CodeSUB12066MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number60
    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 RoleComparator
    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 Standard-Dose Quadrivalent Influenza 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.3.1Product nameStandard-Dose Quadrivalent Influenza Vaccine
    D.3.4Pharmaceutical form Suspension for injection in pre-filled syringe
    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 INNINFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)
    D.3.9.3Other descriptive nameA/H1N1-like strain
    D.3.9.4EV Substance CodeSUB12066MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number15
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)
    D.3.9.3Other descriptive nameA/H3N2-like strain
    D.3.9.4EV Substance CodeSUB12066MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number15
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)
    D.3.9.3Other descriptive nameB/Victoria Lineage
    D.3.9.4EV Substance CodeSUB12066MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number15
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)
    D.3.9.3Other descriptive nameB/Yamagata Lineage
    D.3.9.4EV Substance CodeSUB12066MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number15
    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
    Prevention of influenza infection in adults aged 65-79 years
    E.1.1.1Medical condition in easily understood language
    Active immunisation of adults aged 65-79 years against
    influenza 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 20.0
    E.1.2Level PT
    E.1.2Classification code 10022000
    E.1.2Term Influenza
    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
    Descriptive objective 1: Identifying and recruiting a large sample of Danish citizens aged 65-79 years in the coming 2021/2022 influenza season to assess feasibility, reliability, and validity of the proposed pragmatic RCT study design as assessed by operational endpoints
    E.2.2Secondary objectives of the trial
    Descriptive objective 2: Demonstrating comparability of the QIV-HD vs QIV-SD cohorts to the overall Danish population aged 65-79 years and the population recruited as candidate participants for this study

    Descriptive objective 3: Assuming influenza circulates in Denmark during the 2021/22 season, validate the feasibility conditions by describing event rates in the QIV-HD and QIV-SD participants and calculating relative vaccine effectiveness (rVE) for:
    -Hospitalization for influenza and/or pneumonia
    -Hospitalization for respiratory disease
    -Hospitalization for cardio-respiratory disease

    Descriptive objective 4: Regardless of influenza circulation, validate the feasibility conditions by describing event rates in the QIV-HD and QIV-SD participants and calculating rVE for:
    -Hospitalization for cardiovascular disease
    -Hospitalization for any cause
    -All-cause mortality

    Descriptive objective 5: Calculate rVE for:
    -Hospitalization for COVID-19
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Persons aged 65-79 years are eligible for inclusion into this trial
    2. Informed consent form has been signed and dated
    E.4Principal exclusion criteria
    1. Allergy/hypersensitivity towards the influenza vaccines used in this study
    2. The presence of any contraindication towards vaccination at the day of vaccination
    E.5 End points
    E.5.1Primary end point(s)
    Descriptive objective 1: The following descriptive end-points/indicators will used to assess the feasibility of identifying, recruiting and randomizing a large sample of Danish citizens aged 65-79 years to QIV-HD vs QIV-SD:
    -Number of persons contacted by recruitment letter
    -Number of participants included and randomized to QIV-HD or QIV-SD.
    -Agreement between randomization assignment to QIV-HD or QIV-SD and actual received vaccine
    -Balance between groups in terms of number of subjects in each arm and baseline characteristics
    E.5.1.1Timepoint(s) of evaluation of this end point
    May 31, 2022
    E.5.2Secondary end point(s)
    Descriptive objective 2: The following descriptive end-points/indicators will used to demonstrate comparability between the study populations and overall Danish general population aged 65-79 years and to the population recruited as candidate participants:
    -Comparison of baseline characteristics for the QIV-HD and QIV-SD groups to the overall Danish general population aged 65-79 years
    -Comparison of baseline characteristics for the QIV-HD and QIV-SD groups to the 65-79 years age group population in the DLVS database used for recruitment

    Descriptive objective 3: Adequate influenza circulation for the 2021/2022 season will be prespecified prior to study start. Given that influenza circulation is adequate, the feasibility conditions will be evaluated by describing event rates in the QIV-HD and QIV-SD participants and calculating relative vaccine effectiveness (rVE) for:
    -Hospitalization for influenza and/or pneumonia
    -Hospitalization for respiratory disease
    -Hospitalization for cardio-respiratory disease

    Descriptive objective 4: Regardless of influenza circulation, the feasibility conditions will be evaluated by describing event rates in the QIV-HD and QIV-SD participants and calculating rVE for:
    -Hospitalization for cardiovascular disease
    -Hospitalization from any cause
    -All-cause mortality

    Descriptive objective 5: Calculate rVE for:
    -Hospitalization for COVID-19
    E.5.2.1Timepoint(s) of evaluation of this end point
    May 31, 2022
    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 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
    Effectiveness
    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 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 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) Yes
    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 concerned2
    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
    May 31, 2022
    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 months8
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40000
    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 Yes
    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 state40000
    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 Decision2021-08-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-08-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-11-25
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