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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2009-017690-38
    Sponsor's Protocol Code Number:GRT90
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-03-12
    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 ConcernedFrance - ANSM
    A.2EudraCT number2009-017690-38
    A.3Full title of the trial
    Immunogenicity and Safety of the Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2010-2011 Formulation (Intramuscular Route)
    A.3.2Name or abbreviated title of the trial where available
    Immunogenicity and Safety of a Vaccine against Influenza (2010-2011 NH season, intramuscular route)
    A.4.1Sponsor's protocol code numberGRT90
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 VAXIGRIP
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pasteur SA
    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 nameInfluenza vaccine (split virion, inactivated)
    D.3.2Product code 314
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameInfluenza virus (split virion, inactivated) A/California/7/2009 (H1N1)-like virus
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number150
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameInfluenza virus (split virion, inactivated) A/Perth/16/(H3N2)-like virus
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number150
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameInfluenza virus (split virion, inactivated)B/Brisbane/60/2008-like virus
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number150
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Vaccination of adults up to 60 years of age an elderly of 61 years of age and over with inactivated split-virion influenza vaccine administerd by intramuscular route.
    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
    1) To evaluate the compliance, in terms of immunogenicity, of the influenza vaccine
    (split virion, inactivated) NH 2010-2011 formulation with the requirements of the
    Committee for Proprietary Medicinal Products (CPMP) Note for Guidance (NfG)
    CPMP/BWP/214/96 in both age groups

    2) To describe the safety of the influenza vaccine (split virion, inactivated) NH
    2010-2011 formulation in both age groups
    E.2.2Secondary objectives of the trial
    Not applicable
    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 trial
    enrollment:
    1) Aged 18 years or over on the day of inclusion
    2) Informed consent form has been signed and dated
    3) Able to attend all scheduled visits and to comply with all trial procedures
    4) For a woman of childbearing potential, use of an effective method of
    contraception or abstinence from at least 4 weeks prior to vaccination until at least
    4 weeks after vaccination
    5) Entitled to national social security
    E.4Principal exclusion criteria
    An individual fulfilling any of the following criteria is to be excluded from trial
    enrollment:
    1) Febrile illness (temperature ≥38.0°C) or moderate or severe acute illness/infection
    (according to investigator judgment) on the day of vaccination
    2) Known systemic hypersensitivity to eggs, chicken proteins, neomycin,
    formaldehyde and octoxynol-9, or to any of the vaccine components, or history of
    a life-threatening reaction to the vaccine used in the trial or to a vaccine
    containing any of the same substances
    3) Known pregnancy, or a positive urine pregnancy test
    4) Currently breastfeeding a child
    5) History of pandemic H1N1 influenza vaccination
    6) History of clinically or laboratory confirmed pandemic H1N1 influenza infection
    7) History of influenza vaccination within the previous 6 months (other than
    pandemic H1N1 influenza vaccine)
    8) Receipt of an adjuvanted influenza vaccine in a clinical trial within the previous
    12 months
    9) Known or suspected congenital or acquired immunodeficiency, resulting for
    example from:
    - End-stage renal disease requiring dialysis
    - Active neoplastic disease or active hematologic malignancy
    - Receipt of immunosuppressive therapy or other immune-modifying drugs
    such as, but not limited to: 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)
    10) History of seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B,
    or Hepatitis C
    11) Receipt of blood or blood-derived products in the past 3 months, which might
    interfere with assessment of the immune response
    12) Chronic illness that, in the opinion of the investigator, is at a stage where it might
    interfere with trial conduct or completion
    13) History of thrombocytopenia, contraindicating IM vaccination
    14) Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,
    contraindicating IM vaccination
    15) Receipt of any vaccine in the 4 weeks preceding the trial vaccination
    16) Planned receipt of any vaccine in the 3 weeks following the trial vaccination
    17) Participation in another clinical trial investigating a vaccine, drug, medical device,
    or medical procedure in the 4 weeks preceding the trial vaccination
    18) Planned participation in another clinical trial during the present trial period
    19) Deprived of freedom by an administrative or court order, or in an emergency
    setting, or hospitalized involuntarily
    20) Current alcohol abuse or drug addiction that might interfere with the ability to
    comply with trial procedures
    21) Identified as employees of the Investigator or study center, with direct
    involvement in the proposed study or other studies under the direction of that
    Investigator or study center, as well as family members (i.e., immediate, husband,
    wife and their children, adopted or natural) of the employees or the Investigator
    E.5 End points
    E.5.1Primary end point(s)
    Immunogenicity :

    Immunogenicity will be evaluated before and 21 days after injection of the influenza
    vaccine using the Hemagglutination Inhibition (HAI) technique. For each vaccine
    strain, anti-hemagglutinin (HA) antibody titers will be expressed as HAI titers
    obtained in two independent assays on day (D) 0 and D21 samples, summarized at the
    subject level by individual geometric mean of the two titers on D0 and D21.
    The derived endpoints will be:
    - Individual titer ratio D21/D0,
    - Seroprotection status: titer ≥40 (1/dilution [1/dil]) on D0 and D21,
    - Seroconversion for subjects with a titer <10 (1/dil) on D0: post-injection titer
    ≥40 (1/dil) on D21 or significant increase for subjects with a titer ≥10 (1/dil) on
    D0: ≥4-fold increase of post-injection titer on D21

    Safety :

    Safety will be evaluated within 21 days following injection of the influenza vaccine
    (split virion, inactivated) NH 2010-2011 formulation in subjects aged 18 to 60 years
    and in subjects aged 61 years or older.
    - The occurrence of the following reactions during the first 3 days following vaccination will be more specifically reported (as defined by the CPMP NfG
    CPMP/BWP/214/96):
    - Injection site induration ≥5 cm observed for more than 3 consecutive days
    - Injection site ecchymosis
    - Temperature >38°C for 24 hours or more
    - Malaise
    - Shivering
    - Occurrence of unsolicited adverse events (AEs) reported in the 30 minutes after
    injection
    - Occurrence of solicited (prelisted in the subject diary and the electronic Case
    Report Form [CRF]) injection site reactions and systemic reactions within 7 days
    following injection
    - Occurrence of unsolicited (spontaneously reported) AEs within 21 days
    following injection
    - Occurrence of serious adverse events (SAEs) between V01 up to the end of the
    trial participation
    Others endpoints recorded or derived will be described at the time of statistical
    analysis plan. Depending on the item, these could include: nature (Medical Dictionary
    for Regulatory Activities [MedDRA] preferred term), time of onset, duration, number
    of days of occurrence, Grade of severity, relationship to vaccine, action taken, whether the AE led to early termination from the study, seriousness, or outcome.
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned3
    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 Information not present in EudraCT
    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
    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 months
    E.8.9.1In the Member State concerned days21
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state130
    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 Decision2010-03-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-04-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-05-27
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