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    Summary
    EudraCT Number:2010-018991-25
    Sponsor's Protocol Code Number:GPF18
    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:2010-02-16
    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 number2010-018991-25
    A.3Full title of the trial
    Immunogenicity of the Intramuscular Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine Without Adjuvant in Healthy Adult Subjects
    A.3.2Name or abbreviated title of the trial where available
    Open, phase II trial. 200 subjects aged 18 to 60 years will receive the non-adjuvanted vaccine
    A.4.1Sponsor's protocol code numberGPF18
    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 PANENZA
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pasteur SA
    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 nameSwine A/H1N1 Influenza Vaccine (split virion, inactivated)
    D.3.2Product code 448
    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 (NYMC X-179A) (H1N1)
    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 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) 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.IMP: 2
    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 PANENZA
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pasteur SA
    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 nameSwine A/H1N1 Influenza Vaccine (split virion, inactivated)
    D.3.2Product code 448
    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 (NYMC X-179A) (H1N1)
    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 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) 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
    Preventive vaccination in healthy subjects aged 18 to 60 years against infection with S-OIV (Swine Origin Influenza Virus) A/California/7/2009 (H1N1)
    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
    • To describe the immune response of the inactivated, split-virion swine-origin A/H1N1influenza vaccine without adjuvant in each group
    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 to 60 years 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 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) Known pregnancy, or a positive urine pregnancy test
    2) Currently breastfeeding a child
    3) Participation in another clinical trial investigating a vaccine, drug, medical device,or medical procedure in the 4 weeks preceding the trial vaccination
    4) Planned participation in another clinical trial during the present trial period
    5) Receipt of any vaccine in the 4 weeks preceding the trial vaccination
    6) Receipt of blood or blood-derived products in the past 3 months, which might
    interfere with assessment of the immune response
    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) Self-reported seropositivity for human immunodeficiency virus (HIV), hepatitis B,
    or hepatitis C
    9) Known systemic hypersensitivity 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
    10) Self-reported thrombocytopenia, contraindicating IM vaccination
    11) Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,
    contraindicating IM vaccination
    12) Deprived of freedom by an administrative or court order, or in an emergency
    setting, or hospitalized involuntarily
    13) Current alcohol abuse or drug addiction that might interfere with the ability to
    comply with trial procedures
    14) Chronic illness that, in the opinion of the investigator, is at a stage where it might
    interfere with trial conduct or completion
    15) Employee 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 of the employees or the investigator
    16) Subject previously vaccinated with an A/H1N1 pandemic influenza vaccine
    during vaccination campaign or in clinical trial
    17) Personal history of influenza infection since May 2009
    18) Febrile illness (temperature ≥38.0°C) or moderate or severe acute illness/infection
    on the day of vaccination, according to Investigator judgment
    E.5 End points
    E.5.1Primary end point(s)
    Immunogenicity:

    Anti-hemagglutinin (HA) antibody (Ab) titers against the swine-origin A/H1N1 strain
    measured with the hemagglutination inhibition (HAI) method will be expressed as
    described below:
    - HAI Ab titers will be obtained on D0 and D21. The following endpoints will be
    derived:
    - Individual titers ratio D21/D0
    - Subjects with HAI Ab titer ≥40 (1/dilution [dil]) on D0 and D21
    - Subjects with seroconversion or significant increase in HAI Ab titer, from
    D0 to D21:
    . Seroconversion for subjects with a pre-vaccination titer <10 (1/dil) on
    D0, post-vaccination titer ≥40 (1/dil)
    or
    . Significant increase for subjects with a pre-vaccination titer ≥10 (1/dil), ≥four-fold increase of the titer (post/pre)
    - Subjects with detectable HAI Ab, i.e. with a titer ≥10 (1/dil), on D0 and
    D21
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) 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.8.2.3.1Comparator description
    Same product but 0.5mL administered according to the approved SmPC
    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 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
    The end of the trial is 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 years0
    E.8.9.1In the Member State concerned months6
    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) Yes
    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 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 state200
    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 Decision2010-03-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-03-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-09-21
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