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    Summary
    EudraCT Number:2022-001441-21
    Sponsor's Protocol Code Number:GQM00023
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2022-06-01
    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 number2022-001441-21
    A.3Full title of the trial
    Immunogenicity and Safety of the Quadrivalent Inactivated Split-Virion Influenza Vaccine in Participants 6 Months of age and Older in India
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of the Quadrivalent Influenza Vaccine in Participants 6 months of age and older in India
    A.4.1Sponsor's protocol code numberGQM00023
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1254-0403
    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
    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 AddressDiscovery Drive
    B.5.3.2Town/ citySwiftwater
    B.5.3.3Post codePA 18370-0187
    B.5.3.4CountryUnited States
    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 Yes
    D.2.1.1.1Trade name VaxigripTetra™
    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 nameQuadrivalent influenza vaccine (split-virion, inactivated)
    D.3.2Product code QIV
    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/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 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/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 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/µl microgram(s)/microlitre
    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 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/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
    E.1.1.1Medical condition in easily understood language
    Influenza
    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 describe the immune response induced by quadrivalent influenza vaccine (QIV) in each
    age group
    - To describe the safety profile of QIV in each age group
    E.2.2Secondary objectives of the trial
    Not Applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Aged 6 months and older on the day of inclusion.
    - Participants who are overtly healthy as determined by medical
    evaluation including medical history
    - For participants < 2 years of age: born at full term of pregnancy
    (≥37 weeks) or born after a gestation period of 27 through 36
    weeks and medically stable as assessed by the investigator,
    based on the following definition: “Medically stable” refers to the
    condition of premature infants who do not require significant
    medical support or ongoing management for debilitating disease
    and who have demonstrated a clinical course of sustained
    recovery by the time they receive the first dose of study vaccine.
    - A female participant is eligible to participate if she is not pregnant
    or breastfeeding and one of the following conditions applies:
    • Is of non-childbearing potential. To be considered of
    non-childbearing potential, a female must be premenarche or post-menopausal for at least 1 year, or
    surgically sterile.
    OR
    • Is of childbearing potential and agrees to use an effective
    contraceptive method or abstinence from at least 4
    weeks prior to vaccination until at least 4 weeks after
    vaccination.
    A participant of childbearing potential must have a
    negative highly sensitive pregnancy test (urine or serum
    as required by local regulation) within 24 hours before
    any dose of study intervention.
    - Assent form or informed consent form has been signed and dated
    by the participant (based on local regulations), and if applicable
    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).
    - Participant or participant and parent/legally acceptable
    representative are able to attend all scheduled visits and to
    comply with all study procedures.
    E.4Principal exclusion criteria
    Participants are excluded from the study if any of the following criteria apply:
    - 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)
    - Known systemic hypersensitivity to any of the vaccine
    components, or history of a life-threatening reaction to the
    vaccine used in the study or to a vaccine containing any of the
    same substances
    - Self-reported thrombocytopenia, contraindicating intramuscular
    vaccination
    - Bleeding disorder, or receipt of anticoagulants in the 3 weeks
    preceding inclusion, contraindicating intramuscular vaccination.
    - Alcohol, prescription drug, or substance abuse that, in the opinion
    of the Investigator, might interfere with the study conduct or
    completion
    - Chronic illness that, in the opinion of the investigator, is at a stage
    where it might interfere with study conduct or completion1
    - Moderate or severe acute illness/infection (according to
    investigator judgment) on the day of vaccination or febrile illness
    (temperature ≥ 38.0°C [≥ 100.4°F]). A prospective participant
    should not be included in the study until the condition has
    resolved or the febrile event has subsided
    - Receipt of any vaccine in the 4 weeks preceding the first study
    vaccination or planned receipt of any vaccine before Visit 2 for
    participants receiving 1 dose of influenza vaccine or Visit 3 for
    participants receiving 2 doses of influenza vaccine (except Oral
    Poliomyelitis vaccine received during National Immunization
    Days).
    - Receipt of the coronavirus vaccine (severe acute respiratory
    syndrome coronavirus 2 [SARS-CoV-2]) in the 4 weeks preceding
    the first study vaccination.
    - Previous vaccination against influenza (in the previous 9 months)
    with either the study vaccine or another vaccine
    - Receipt of immune globulins, blood, or blood-derived products in
    the past 3 months
    - Participation at the time of study enrollment (or in the 4 weeks
    preceding vaccination) or planned participation during the present
    study period in another clinical study investigating a vaccine,
    drug, medical device, or medical procedure.
    - Deprived of freedom by an administrative or court order, or in an
    emergency setting, or hospitalized involuntarily
    - Identified as an Investigator or employee of the Investigator or
    study center with direct involvement in the proposed study, or
    identified as an immediate family member (ie, 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- Anti-hemagglutinin individual (HAI) titer: HAI titer are measured
    2- Individual HAI titers ratio: Ratio Day 29/Day 01 or Day 57/Day 01
    3- Percentage of participants with detectable HAI titer: Detectable HAI titer is defined as a titer ≥ 10 (1/dil)
    4- Percentage of participants with seroconversion: Seroconversion is defined as titer < 10 [1/dil] at Day 01 and post-vaccination
    titer ≥40 [1/dil] at Day 29 or Day 57 or titer ≥ 10 [1/dil] at Day 01 and a ≥ 4-
    fold rise in titer [1/dil] at Day 29 or Day 57
    5- HAI titer above predefined threshold: HA titer ≥ 40 (1/dil)
    6- Number of participants with immediate adverse events: Immediate adverse events are any unsolicited systemic adverse events
    reported in the 30 minutes after vaccination
    7- Number of participants with solicited injection site reactions: Solicited injection site reactions include for
    - Infants and toddlers aged ≤ 23 months: injection site tenderness, erythema,
    swelling, induration and bruising
    - Children aged 2 through 11 years, adolescents and adults aged ≥ 12 years:
    injection site pain, erythema, swelling, induration and bruising
    8- Number of participants with solicited systemic reactions: Solicited systemic reactions include for
    - Infants and toddlers aged ≤ 23 months: fever, vomiting, crying abnormal,
    drowsiness, appetite lost and irritability
    - Children aged 2 through 11 years, adolescents and adults aged ≥ 12 years:
    fever, headache, malaise, myalgia and shivering
    9- Number of participants with unsolicited adverse events (AEs): Unsolicited (spontaneously reported) AEs, including adverse events of special
    interest (AESIs), not fulfilling criteria for solicited adverse reactions
    10- Number of participants with serious adverse events (SAEs): SAEs, including serious AESIs
    E.5.1.1Timepoint(s) of evaluation of this end point
    1, 3 and 5: Day 01 and 28 days after the last vaccination (Day 29 or Day 57)
    2: Day 01, Day 29 or Day 57
    4: Day 29 or Day 57
    6: Within 30 minutes of vaccination
    7 and 8: Within 7 days of vaccination
    9: Within 28 days of vaccination
    10: From Day 01 to Day 29 or Day 57
    E.5.2Secondary end point(s)
    Not Applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not Applicable
    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
    Immunogenicity
    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 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 trial1
    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
    India
    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
    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 months4
    E.8.9.2In all countries concerned by the trial days17
    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: 300
    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: 70
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 160
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 70
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 Yes
    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
    pediatric population
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    elderly
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 400
    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: India
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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