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    Summary
    EudraCT Number:2019-001401-25
    Sponsor's Protocol Code Number:QHD00012
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-07-24
    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 ConcernedFinland - Fimea
    A.2EudraCT number2019-001401-25
    A.3Full title of the trial
    Relative Effectiveness of a High-Dose Quadrivalent Influenza Vaccine versus a Standard-Dose Quadrivalent Influenza Vaccine in Subjects 65 Years of Age and Older
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Evaluate the Effectiveness of a High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Compared to a Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) in Adults 65 Years of Age and Older
    A.4.1Sponsor's protocol code numberQHD00012
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1217-2654
    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 SponsorSanofi Pasteur Inc.
    B.1.3.4CountryUnited States
    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 supportSanofi Pasteur
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi Pasteur
    B.5.2Functional name of contact pointStéphanie Pepin
    B.5.3 Address:
    B.5.3.1Street Address1541 avenue Marcel Mérieux
    B.5.3.2Town/ cityMarcy l'Etoile
    B.5.3.3Post code69280
    B.5.3.4CountryFrance
    B.5.4Telephone number+33437 37 5850
    B.5.6E-mailStephanie.Pepin@sanofi.com
    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.2.5The 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 namequadrivalent influenza vaccine high dose
    D.3.2Product code 522
    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 VaxigripTetra
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pasteur Europe
    D.2.1.2Country which granted the Marketing AuthorisationFinland
    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 nameVaxigripTetra
    D.3.2Product code J07BB
    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 from 65 years of age and older
    E.1.1.1Medical condition in easily understood language
    Active immunisation of adults from 65 years of age and older 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
    To demonstrate the superior relative effectiveness of QIV-HD as compared to QIV-SD among persons 65 years of age and older for the prevention of cardiovascular and/or respiratory hospitalizations
    E.2.2Secondary objectives of the trial
    - To assess the clinical relative effectiveness of QIV-HD as compared to QIV-SD in prevention of:
    inpatient hospitalization for selected circulatory and respiratory causes
    death, either all-cause or cardiovascular or respiratory causes
    inpatient hospitalization (using primary and secondary discharge diagnoses)
    inpatient hospitalization (using admission diagnoses)
    hospital emergency room visits
    primary care visits to physician
    or
    - major acute cardiovascular events (MACE)
    - To assess the characteristics of inpatient hospitalization or hospital emergency room visits or primary care visits to physician by QIV-HD and QIV-SD groups
    - To describe the clinical relative effectivenes of QIV-HD as compared to QIV-SD:
    - by age group and by group with specific comorbidities
    - for different periods of observation
    To describe all serious adverse events (SAEs) (including adverse event of special interest [AESIs]) for all subjects in both QIV-HD and QIV-SD groups
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Aged 65 years or older on the day of inclusion ("65 years" means from the day of the 65th birthday)
    E.4Principal exclusion criteria
    - Participation at the time of study enrollment (or in the 4 weeks [28 days] preceding the study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
    - Previous vaccination against influenza (in the preceding 6 months) with either the study vaccines or another vaccine
    - Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances
    E.5 End points
    E.5.1Primary end point(s)
    Number of unscheduled cardiovascular or respiratory inpatient hospitalizations
    First occurrence of an unscheduled cardiovascular or respiratory inpatient hospitalization will be considered

    Number of inpatient hospitalizations with primary discharge diagnosis (for circulatory and respiratory systems diseases only)
    Inpatient hospitalizations with primary discharge diagnosis (using International Classification of Diseases, Tenth Revision [ICD-10] codes) for the following diseases will be considered:
    - Diseases of the circulatory system
    - Diseases of the respiratory system
    E.5.1.1Timepoint(s) of evaluation of this end point
    Number of unscheduled cardiovascular or respiratory inpatient hospitalizations : From 14 days after vaccination to 31 May of each year

    Number of inpatient hospitalizations with primary discharge diagnosis (for circulatory and respiratory systems diseases only) : From 14 days after vaccination to 31 May of each year
    E.5.2Secondary end point(s)
    Number of inpatient hospitalizations with primary discharge diagnosis
    Inpatient hospitalization with primary discharge diagnosis (using ICD-10 codes) for the following diseases will be considered:

    - Diseases of the respiratory system
    - Diseases of the circulatory system
    - Pneumonia
    - Heart failure
    - Acute myocardial infarction
    - Atrial Fibrillation
    - Stroke
    - Influenza and pneumonia


    Number of deaths
    Death all-cause and based on the diseases listed in first secondary endpoint will be considered

    Number of inpatient hospitalizations with primary and secondary admission and discharge diagnoses
    Inpatient hospitalization with primary discharge and second admission discharge diagnosis based on the diseases listed in first secondary endpoint will be considered

    Number of hospital emergency room visits
    Hospital emergency room visits based on the diseases listed in first secondary endpoint will be considered

    Number of acute primary care visits to physician
    Acute primary care visits to physician based on the diseases listed in first secondary endpoint (using ICD-10 or corresponding International Classification of Primary Care 2nd edition [ICPC-2] codes) will be considered

    Number of major acute cardiovascular events (MACE)
    First occurrence of the following MACE (using ICD-10 codes) will be considered:
    - Ischemic heart diseases
    - Non-fatal myocardial infarction
    - Fatal or non-fatal stroke based
    - Unstable angina

    Number of unscheduled cardiovascular or respiratory inpatient hospitalizations or hospital emergency room visits or primary care visits to physician
    For all occurrences of selected outcomes the following characterization will be described:
    - Onset of event
    - Duration of event

    Number of participants reporting listed serious adverse events (SAEs)
    Number of serious adverse reactions (SARs), adverse event of special interest (AESI)s, and all fatal cases occuring throughout the study will be considered

    Number of participants reporting non-fatal SAEs
    Non-fatal SAEs occuring up to 6 months after vaccination will be considered
    E.5.2.1Timepoint(s) of evaluation of this end point
    From 14 days after vaccination to 31 May of each year :
    -Nb of inpatient hospitalizations with primary discharge diagnosis
    -Nb of deaths
    -Nb of inpatient hospitalizations with primary and secondary admission and discharge diagnoses
    -Nb of hospital emergency room visits
    -Nb of acute primary care visits to physician
    -Nb of major acute cardiovascular events (MACE)
    -Nb of unscheduled cardiovascular or respiratory inpatient hospitalizations or hospital emergency room visits or primary care visits to physician

    From Day 0 (post-vaccination) up to 11 months (post-vaccination) :
    - Nb of participants reporting listed serious adverse events (SAEs)

    From Day 0 (post-vaccination) up to 6 months (post-vaccination) :
    - Nb of participants reporting non-fatal SAEs
    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) No
    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 No
    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
    modified double blind
    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 concerned140
    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 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
    End of Year 2 data collection period (approximately 11 months after Year 2 vaccination).
    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 months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days0
    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: 68000
    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 state68000
    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
    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 Decision2019-09-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-08-07
    P. End of Trial
    P.End of Trial StatusOngoing
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