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    Summary
    EudraCT Number:2006-000477-29
    Sponsor's Protocol Code Number:GPA02
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-03-30
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2006-000477-29
    A.3Full title of the trial
    Safety and immunogenicity of an intramuscular, inactivated, split-virion, pandemic influenza A/H5N1 vaccine in adults and the elderly.
    A.4.1Sponsor's protocol code numberGPA02
    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 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 nameA/H5N1 inactivated, adjuvanted, split virion influenza vaccine made in embryonated eggs
    D.3.2Product code 402
    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 nameInactivated split influenza virus A/Indonesia/5/05-RG2 (H5N1)
    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 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) 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 (18-60 years) and elderly (>60 years) with pandemic flu H5N1 vaccine.
    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 injection site reactions and systemic safety profile during the 21 days following each of 2 primary series and 1 booster (as applicable) intramuscular injections in 2 age groups: subjects aged 18 to 60 yrs (adults) or >60 yrs (elderly)
    •To describe the immune response 21 days after each of 2 primary series IM injections in 2 age groups: subjects aged 18 to 60 yrs and >60 yrs
    •To describe the antibody persistence at M6 (D180) (all subjects), M15 and M22 (subsets of subjects) after the first vaccination in two age groups: subjects aged 18 to 60 years (adults) or >60 years (elderly)
    •To describe the immune response 21 days after a booster vaccination administered at 6 mths (A/Vietnam booster) or 7 and 21 days after a booster vaccination administered at 22 mths (A/Indonesia booster) after the first vaccination in 2 age groups: subjects aged 18 to 60 yrs or >60 yrs
    •To describe any serious adverse events during entire trial
    E.2.2Secondary objectives of the trial
    No secondary objective
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Aged over 18 years on the day of inclusion, and 18 to 60 years for the 50 additional subjects for A/Indonesia primary series.
    2) Informed consent form signed.
    3) Able to attend all scheduled visits and to comply with all trial procedures.
    4) For a woman, inability to bear a child or negative urine pregnancy test.
    5) For a woman of child-bearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior and at least 4 weeks after to each vaccination.
    6) Addendum 1 of the informed consent form signed and dated by the subject (this inclusion criteria has to be checked only at V04 for subjects who are to receive a booster at M6 or later).
    7) Addendum 2 of the informed consent form signed and dated by the subject (this inclusion criteria has to be checked only at V04_Add for subjects who are to receive a A/Indonesia booster.
    8) Addendum 3 of the Informed Consent Form signed and dated by the subject (this inclusion criterion has to be checked only at V05 for subjects who are to receive a A/Indonesia booster).
    E.4Principal exclusion criteria
    1) Systemic hypersensitivity to any component of the vaccine or a life-threatening reaction after previous administration of a vaccine containing the same substances (egg proteins, chick proteins, thimerosal, aluminum, neomycin, formaldehyde, and octoxinol 9).
    2) Febrile illness (oral temperature ≥37.5°C) on the day of inclusion.
    3) Breast-feeding.
    4) Previous vaccination with an avian flu vaccine.
    5) Participation in a clinical trial (drug, device, or medical procedure) within 4 weeks prior to the first vaccination.
    6) Planned participation in another clinical trial during the present trial period.
    7) 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.
    8) Chronic illness that could interfere with trial conduct or completion (e.g. cardiac, renal, diabetes, or auto-immune disorders).
    9) Current alcohol or drug abuse that may interfere with the subject’s ability to comply with trial procedures.
    10) Receipt of blood or blood-derived products within the past 3 months.
    11) Any vaccination within 4 weeks prior to the first trial vaccination.
    12) Vaccination planned within 4 weeks after any trial vaccination.
    13) Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
    14) Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
    E.5 End points
    E.5.1Primary end point(s)
    Safety
    •The occurrence, time to onset, number of days of occurrence, and severity of solicited (prelisted in the subject diary and Case Report Form) injection site reactions and systemic reactions occurring within 7 days following each injection will be reported.
    •The occurrence, nature (Medical Dictionary for Regulatory Activities [MedDRA]preferred term), time to onset, duration, severity, relationship to vaccination and seriousness of unsolicited (spontaneously reported) adverse events (AEs) within 21 days following each injection will be reported.
    •The occurrence of the following reactions (MedDRA Preferred Terms given in parentheses) in the 3 days following each injection will be more especially reported (as defined by the European Medicines Agency Note for Guidance [CPMP/BWP/214/96]):
    •Injection site induration >5 cm observed for more than 3 days.
    •Injection site ecchymosis (injection site hemorrhage).
    •Rectal equivalent temperature >38°C for 24 hours or more.
    •Malaise.
    •Shivering (chills).
    •The occurrence, nature, time to onset, and relationship to vaccination of SAEs during whole trial (including the 6 mth follow-up period) will be reported.

    Immunogenicity
    Primary series
    Hemagglutination inhibition assays will be performed using:
    1.Horse erythrocytes (hemagglutination inhibition using horse erythrocytes [HIH] method) for all subjects.
    2.Turkey erythrocytes (hemagglutination inhibition using turkey erythrocytes [HIT] method) for a subset of 80 subjects in each formulation group (40 subjects per age sub-group) for one vaccine strain only - H5N1 A/Vietnam: A/Vietnam/1194/2004/NIBRG-14 (H5N1) (henceforth referred to as A/Vietnam).
    Anti-Hemagglutinin (anti-HA) titers against the A/H5N1 strain will be expressed as described below:
    •Anti-HA Ab titer obtained in duplicate on D0, D21, and D42, and summarized at the subject level by individual geometric means of duplicates at each timepoint. The following endpoints will be derived:
    •Individual titer ratios D21/D0, D42/D0, and D42/D21.
    •Proportion of subjects with titer ≥40 (turkey) or ≥32 (horse) 1/dilution (dil) on D0, D21 and D42.
    •Seroconversion (for subjects with a titer <10 [turkey] or <8 [horse] [1/dil] on D0: post-injection titer
    ≥ 40 [turkey] or ≥32 [horse] [1/dil])
    or
    •significant increase (for subjects with a titer ≥10 [turkey] or ≥8 [horse] [1/dil]: ≥4-fold increase of the titer) at D21 and D42.

    AND
    Neutralizing Ab titers against the A/H5N1 strain will be expressed as described below
    •Neutralizing Ab titer obtained in duplicate on D0, D21, and D42 and summarized at the subject level by individual geometric mean of duplicates at each timepoint. The following endpoints will be derived:
    •Individual titer ratios D21/D0, D42/D0, and D42/D21.
    •2- and 4-fold increase from D0 to D21 and to D42.

    Antibody persistence
    Anti-HA Ab titer (HIH method) and neutralizing Ab titer (seroneutralization [SN] method) at M6 (D180) (all subjects) M15 and M22 (subsets of subjects).

    Booster vaccination response
    The A/Vietnam H5N1 strain will be used for the 6-mth booster, and an A/Indonesia/5/05-RG2 (H5N1) strain (henceforth referred to as A/Indonesia) will be used for the 22-mth booster. The booster Ab response will be assessed against the homologous strain in the vaccine, with HI test using horse erythrocytes and SN method. In addition, the antibody response to heterologous strains may be tested.
    •Anti-HA Ab titer obtained in duplicate at M6 (D180) and M6+21 days (D201) (if 6 month A/Vietnam booster) or M22 (D670), M22+7 days (D677) and M22 +21 days (D691) (if 22-mth A/Indonesia booster), and summarized at the subject level by individual geometric means of duplicates at each timepoint. The following endpoints will be derived:
    •Individual titer ratios M6+21D/M6 (if 6-mth A/Vietnam booster) or, M22+7D/M22 and M22+21D/M22 (if 22-mth A/Indonesia booster).
    •Proportion of subjects with anti-HA Ab titer ≥32 (1/dil) at M6 and M6+21D (if 6-month A/Vietnam booster) or M22, M22+7D and M22+21D (if 22-mth A/Indonesia booster).
    •Seroconversion: for subjects with a titer <8 (1/dil) at M6 or M22: post injection titer ≥32 [1/dil]) at M6+21D (if 6-mth A/Vietnam booster), or M22+7D or M22+21D (if 22-mth A/Indonesia booster), or a significant increase (for subjects with a titer ≥8 [1/dil]: ≥4-fold increase of the titer) at M6+21D (if 6-mth A/Vietnam booster), or M22+7D and M22+21D (if 22-mth A/Indonesia booster).

    AND
    •Neutralizing Ab titer obtained at M6 and M6+21D (if 6-month A/Vietnam booster) or M22, M22+7D and M22+21D (if 22-month A/Indonesia booster). The following endpoints will be derived:
    •Individual titer ratios M6+21D/M6 (if 6-month A/Vietnam booster)or M22+7D/M22 and M22+21D/M22 (if 22-month A/Indonesia booster).
    •2- and 4-fold increase from M6 to M6+21D (if 6-month A/Vietnam booster) or from M22 to M22+7D and from M22 to M22+21D (if 22-month A/Indonesia booster).
    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 Information not present in EudraCT
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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
    Information provided in the protocol
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    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 state500
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 650
    F.4.2.2In the whole clinical trial 650
    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 plans for treatment or care after the subject has ended the participation in the trial
    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 Decision2006-05-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-05-03
    P. End of Trial
    P.End of Trial StatusCompleted
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