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    Summary
    EudraCT Number:2017-001044-35
    Sponsor's Protocol Code Number:GQM00016
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-02-08
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2017-001044-35
    A.3Full title of the trial
    Immunogenicity and Safety of a Multi-Dose Quadrivalent Influenza Vaccine in Children Aged 6 months to 17 Years
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immunogenicity and Safety of a Multi-Dose Quadrivalent Influenza Vaccine in Children Aged 6 months to 17 Years
    A.3.2Name or abbreviated title of the trial where available
    Immunogenicity and Safety of a Multi-Dose Quadrivalent Influenza Vaccine
    A.4.1Sponsor's protocol code numberGQM00016
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03391193
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1183-5881
    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 SA
    B.1.3.4CountryFrance
    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 pointTrial Transparency Team
    B.5.3 Address:
    B.5.3.1Street Address-
    B.5.3.2Town/ city-
    B.5.3.3Post code-
    B.5.3.4CountryFrance
    B.5.6E-mailContact-US@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 (split-virion, inactivated) in a multi-dose vial
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNA/H1N1 strain
    D.3.9.3Other descriptive nameA/H1N1 INFLUENZA VACCINE
    D.3.9.4EV Substance CodeSUB30877
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNA/H3N2 strain
    D.3.9.3Other descriptive nameA/VICTORIA/361/2011 (H3N2)
    D.3.9.4EV Substance CodeSUB181230
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNB/Victoria lineage strain
    D.3.9.3Other descriptive nameB/COLORADO/06/2017-LIKE STRAIN (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A)
    D.3.9.4EV Substance CodeSUB191972
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNB/Yamagata lineage strain
    D.3.9.3Other descriptive nameINFLUENZA B/YAMAGATA/16/88 LINEAGE VIRUS
    D.3.9.4EV Substance CodeSUB129428
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 Quadrivalent influenza vaccine (split virion, inactivated) - Vaxigrip Tetra
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI PASTEUR
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameSingle-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
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNA/H1N1 strain
    D.3.9.3Other descriptive nameA/H1N1 INFLUENZA VACCINE
    D.3.9.4EV Substance CodeSUB30877
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNA/H3N2 strain
    D.3.9.3Other descriptive nameA/VICTORIA/361/2011 (H3N2)
    D.3.9.4EV Substance CodeSUB181230
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNB/Victoria lineage strain
    D.3.9.3Other descriptive nameB/COLORADO/06/2017-LIKE STRAIN (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A)
    D.3.9.4EV Substance CodeSUB191972
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNB/Yamagata lineage strain
    D.3.9.3Other descriptive nameINFLUENZA B/YAMAGATA/16/88 LINEAGE VIRUS
    D.3.9.4EV Substance CodeSUB129428
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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
    Prophylaxis of influenza (Northern Hemisphere 2017-2018 season) in children aged 6 months to 17 years
    E.1.1.1Medical condition in easily understood language
    Prophylaxis of influenza (Northern Hemisphere 2017-2018 season) in children aged 6 months to 17 years
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    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
    Immunogenicity - To describe the HAI antibody response induced by QIV in MDV presentation compared with QIV in syringe presentation for the four strains.
    E.2.2Secondary objectives of the trial
    Safety - To assess the safety profile of both vaccines during the 28 days following any vaccination, and SAEs (including AESIs) throughout the study.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    An individual must fulfill all of the following criteria in order to be eligible for study enrollment:

    1) Aged 6 months to 17 years on the day of inclusion

    2) Assent form has been signed and dated by the subject aged 7 to 17 years, and informed consent form has been signed and dated by the parent(s) or
    another legally acceptable representative and by an independent witness, if required by local regulations

    3) Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all study procédures

    4) Covered by health insurance, if required by local regulations
    E.4Principal exclusion criteria
    An individual fulfilling any of the following criteria is to be excluded from study enrollment:

    1) Subject is pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks
    prior to vaccination until at least 4 weeks after vaccination. To be considered of non-childbearing potential, a female must be pre-menarche.

    2) Participation at the time of study enrollment (or in the 4 weeks preceding the first study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, device, or medical procedure

    3) Receipt of any vaccine or planned receipt of any vaccine within the period from 2 weeks before the first study vaccination to 2 weeks following the last study vaccination

    4) Previous vaccination against influenza (in the preceding 6 months) with either the study vaccine or another vaccine for subjects aged 9 to 17 years

    5) For subjects aged 6 months to 8 years:

    · Any influenza vaccination (from birth to the day of inclusion) with either the study vaccine or another vaccine

    · Any previous laboratory confirmed influenza infection

    6) Receipt of immune globulins, blood or blood-derived products in the past 3 months

    7) Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive
    weeks within the past 3 months)

    8) 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

    9) Laboratory-confirmed / self-reported / reported by the parent(s) / legally acceptable representative Thrombocytopenia, contraindicating IM vaccination

    10) Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination

    11) Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily

    12) Current alcohol abuse or drug addiction

    13) Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion

    14) Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature
    ≥ 38.0°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided

    15) Identified as Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e. parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study
    E.5 End points
    E.5.1Primary end point(s)
    1.Geometric Mean Titers (GMTs) of Antibodies after Vaccination with Multi-dose Quadrivalent Influenza Vaccine or Single-dose Quadrivalent Influenza Vaccine
    Anti-hemagglutinin (HA) antibody titers against the 4 influenza strains are assessed by a hemagglutination inhibition (HAI) assay

    2.GMT Ratio after Vaccination with Multi-dose Quadrivalent Influenza Vaccine or Single-dose Quadrivalent Influenza Vaccine
    Anti-HA antibody titers against the 4 influenza strains are assessed by an HAI assay. GMT ratio is assessed as the individual ratio of post-/pre-vaccination titers

    3.Seroconversion Rates after Vaccination with Multi-dose Quadrivalent Influenza Vaccine or Single-dose Quadrivalent Influenza Vaccine
    Anti-HA antibody titers against the 4 influenza strains are assessed by an HAI assay. Seroconversion is defined as either post-vaccination titer ≥ 40 (1/dil), or pre-vaccination titer ≥ 10 (1/dil) and ≥ 4-fold increase in post-vaccination titer
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 28 (post-last vaccination) for all 3 primary endpoints
    E.5.2Secondary end point(s)
    1.Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions after Vaccination with Multi-dose Quadrivalent Influenza Vaccine or Single-dose Quadrivalent Influenza Vaccine [ Time Frame: Day 0 (pre-vaccination) to Day 7 (after any vaccination) ]
    Solicited injection site reactions are tenderness/pain,erythema, swelling, induration, ecchymosis, and solicited systemic reactions are fever, vomiting, crying abnormal, drowsiness, appetite lost, irritability (for children ≤ 23 months), and fever, headache, malaise, myalgia, and shivering (for children 2 to 17 years)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 0 (pre-vaccination) to Day 7 (after any vaccination)
    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 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) 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 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 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Mexico
    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.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days6
    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: 360
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 120
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 120
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 120
    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
    toddlers, children, adolescents (minors)
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 360
    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
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Mexico
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