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    Summary
    EudraCT Number:2010-019835-37
    Sponsor's Protocol Code Number:GPF15
    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:2010-05-17
    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 number2010-019835-37
    A.3Full title of the trial
    Safety and Immunogenicity of an Intramuscular H5N1 Inactivated, Split Virion Influenza Vaccine Adjuvanted with AF03 in Adults and Elderly subjects
    A.4.1Sponsor's protocol code numberGPF15
    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 namePandemic Flu Vaccine (H5N1) (split virion, inactived, adjuvanted with AF03)
    D.3.2Product code 414
    D.3.4Pharmaceutical form Emulsion 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 nameInactived 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 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 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 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 namePandemic Flu Vaccine (H5N1) (split virion, inactived)
    D.3.2Product code 364
    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 nameInactived 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 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 study in healthy subjects aged 18-60 years and over 60 years against infection with H5N1 Influenza Virus A/Indonesia/5/05-RG2 (H5N1)
    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 safety profile of the vaccines (injection site reactions and systemic events) either 21 days after each injection in subjects vaccinated following the D0-D21 or D0-D42 schedules or, 14 days and 21 days after the first and second injection respectively, in subjects vaccinated following the D0-D14 schedule

    • To describe the immunogenicity 21 days after each vaccine injection in a randomized subset of subjects vaccinated following the D0-D21 schedule and participating to immunogenicity evaluation

    • To describe the persistence of antibodies (Ab) 6 and 12 months after the second vaccine injection in the randomized subset of subjects vaccinated following the D0-D21 schedule and participating to immunogenicity evaluation.
    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, use of an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until at least 4 weeks after the last vaccination, or having undergone a surgical sterilization or being post-menopausal
    5) Covered by health insurance or entitled to national social security depending on local regulations
    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 first 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 first trial vaccination
    6) Planned receipt of any vaccine prior to the blood sample performed 21 days after the second trial vaccination
    7) Previous vaccination with an H5N1 vaccine
    8) History of H5N1 infection or exposure to presumed/confirmed (either clinically, serologically, or microbiologically) cases of H5N1-infected humans or animals
    9) Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
    10) 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)
    11) Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C
    12) Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
    13) Self-reported thrombocytopenia, contraindicating IM vaccination
    14) Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination in the opinion of the investigator
    15) Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
    16) Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures
    17) Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
    18) 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.
    19) Febrile illness (temperature ≥38.0°C) or moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination
    20) Receipt of any vaccine with an adjuvant (except for aluminum) in a context of a clinical trial in the past 2 years
    21) Receipt of an A/H1N1 pandemic influenza vaccine in the context of the national pandemic vaccination campaign 2009-2010
    22) Known or suspected autoimmune disease or systemic disease (e.g. Sjögren syndrome, lupus erythematosus, rhumatoïde arthritis, sarcoïdosis, vasculitis, etc…)
    E.5 End points
    E.5.1Primary end point(s)
    Safety
    • Occurrence of unsolicited adverse event (AE) reported in the 30 minutes after each/any injection
    • Occurrence of solicited (prelisted in the subject diary and electronic Case Report Form [eCRF]) injection site reactions and systemic reactions within 7 days following each/any injection
    • Occurrence of unsolicited (spontaneously reported) AEs within 21 days following each/any injection in subjects vaccinated following the D0-D21 or D0-D42 schedules or, 14 days and 21 days after the first and second injection respectively, in subjects vaccinated following the D0-D14 schedule
    • Occurrence of the following solicited reactions (Medical Dictionary for Regulatory Activities [MedDRA] Preferred Terms given in parentheses) in the 3 days following each injection will be more specifically reported (as defined by the European Medicines Agency (EMEA) Note for Guidance [CPMP/BWP/214/96]):
    - Injection site induration ≥5 cm for at least 4 consecutive days following each injection
    - Injection site ecchymosis (injection site hemorrhage) in the 3 days following each injection
    - Temperature >38°C (pyrexia) for 24 hours or more in the 3 days following each injection
    - Malaise in the 3 days following each injection
    - Shivering (chills) in the 3 days following each injection
    • Occurrence of serious AEs (SAEs) including adverse events of special interest (AESI) throughout the trial
    Other endpoints recorded or derived will be described at the time of statistical analysis plan. Depending on the item, these could include: nature (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.
    Note: The following AESIs, considered as important medical events are to be considered as SAEs and reported to the Sponsor: anaphylaxis, Guillain-Barré syndrome (GBS), encephalitis, Bell’s palsy, neuritis, convulsions, vasculitis, demyelinating disorders and any suspected/confirmed autoimmune disease including Sjögren Syndrome.


    Immunogenicity
    Anti-HA Ab titers against the H5N1 strain will be measured using hemagglutination inhibition (HAI) assay using horse erythrocytes (HIH) and seroneutralization (SN) methods. Anti-HA Ab titers will be expressed as described below:

    => Primary Series:
    • HAI and SN Ab titers will be obtained on D0 and D21 on a randomized subset of subjects vaccinated following the D0-D21 schedule. The following endpoints will be derived:
    • Individual titers ratio D21/D0, D42/D0 and D42/D21 (HAI and SN)
    • Subjects with titer ≥40 (1/dilution [dil]) on D0, D21 and D42 (HAI and SN).
    • Subjects with seroconversion or significant increase in HAI Ab titer, from D0 to D21 or D0 to D42 (HAI):
    - 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 Ab, i.e. with a titer ≥10 (1/dil) (HAI and SN), ≥20 and ≥80 (1/dil) (SN only) on D0, D21 and D42
    • Percentage of subjects achieving a 2 and 4-fold increase of titers (SN only) from D0 to D21 and D0 to D42

    => Ab Persistence:
    • HAI Ab titers will be obtained at Vac2+6M and Vac2+12M on a randomized subset of subjects. The following endpoints will be derived:
    • Subjects with detectable Ab, i.e. with a titer ≥10 (1/dil) (HAI and SN), ≥20, ≥40 and ≥80 (1/dil) (SN only) at Vac2+6M and Vac2+12M
    • Subjects with HAI Ab titer ≥40 (1/dil) at Vac2+6M and Vac2+12M
    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 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.8.3 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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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 years
    E.8.9.1In the Member State concerned months14
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months14
    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) 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 state250
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 3200
    F.4.2.2In the whole clinical trial 3200
    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)
    Not applicable
    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 Decision2010-06-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-06-29
    P. End of Trial
    P.End of Trial StatusCompleted
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