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    Summary
    EudraCT Number:2008-005791-27
    Sponsor's Protocol Code Number:GPA12
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-01-12
    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 ConcernedFinland - Fimea
    A.2EudraCT number2008-005791-27
    A.3Full title of the trial
    Safety and Immunogenicity of an Intramuscular A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine in European Children
    A.4.1Sponsor's protocol code numberGPA12
    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 nameFLU H5N1 30µgHA+aluminum hydroxide
    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 typeequal
    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 healthy children aged 6 months to 17 years with pandemic Flu H5N1 vaccine (30µgHA+aluminum hydroxide 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 safety profiles (injection site reactions and systemic events) during the 21 days following each vaccination in subjects receiving the D0-D21 and the D0-D42 vaccination schedules, and 14 days and 21 days after Vac1 and Vac2, respectively, in subjects aged 9 to 17 years receiving the D0-D14 vaccination schedule
    • To describe the immune response 21 days after each vaccination in subjects receiving the D0-D21 vaccination schedule
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All Subjects:

    1) Subject and parent(s)/legal representative able to attend all scheduled visits and to comply with all trial procedures
    2) Completion of vaccination according to the national immunization schedule

    Subjects Aged ≥2 Years to <18 Years:

    3) Aged ≥2 years to <18 years on the day of inclusion.
    4) Provision of Informed Consent Form signed by the subject's the parent(s)/legal representative (and by an independent witness if required by local regulations). In addition, provision of Assent Form signed by subjects aged 8 to 11 years, and of Informed Consent Form signed by subjects ≥12 years.
    5) For a female of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to each vaccination, until at least 4 weeks after each vaccination.

    Subjects Aged ≥6 Months to <2 Years:

    6) Aged ≥6 months to <2 years on the day of inclusion.
    7) Born at full term of pregnancy (≥37 weeks) with a birth weight ≥2.5 kg.
    8) Provision of Informed Consent Form signed by the parent(s) or other legal representative (and by an independent witness if required by local regulations).
    E.4Principal exclusion criteria
    All subjects:

    1) Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding trial vaccination
    2) Planned participation in another clinical trial during the present trial period
    3) Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy
    4) Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances
    5) Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the investigator
    6) Current alcohol abuse or drug addiction that may interfere with the subject’s ability to comply with trial procedures
    7) Receipt of Blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response
    8) Receipt of any vaccine in the 4 weeks preceding trial vaccination
    9) Planned receipt of any vaccine in the 4 weeks following any trial vaccination
    10) (Known) Human Immunodeficiency Virus (HIV), HBs antigen or Hepatitis C seropositivity
    11) Previous vaccination against avian influenza with either the trial vaccine or another vaccine
    12) Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination
    13) Subjects deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
    14) Received oral or injected antibiotic therapy within the 72 hours prior to any blood draw

    Subjects Aged ≥2 Years to <18 Years:

    15) For a female of child-bearing potential, known pregnancy or positive urine pregnancy test
    16) Breast-feeding female
    17) Febrile illness (temperature ≥37.5°C) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment

    Subjects Aged ≥6 Months to <2 Years:

    18) History of seizures
    19) Febrile illness (temperature ≥38°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)
    Safety:

    • Occurrence, nature, (Medical Dictionary for Regulatory Activities [MedDRA] preferred term), duration, severity (for non-serious AEs), action taken and relationship to vaccination of any unsolicited systemic adverse events (AEs) reported in the 30 minutes after each injection
    • Occurrence, time to onset, number of days of occurrence, action taken and severity of solicited (pre-listed in the subject diary and Case Report Form [CRF]) injection site reactions and systemic reactions occurring up to 7 days following each injection
    • Occurrence, nature (MedDRA preferred term), time to onset, duration, severity (for non-serious AEs), action taken and relationship to vaccination of unsolicited (spontaneously reported) AEs within 21 days following each injection, as applicable*
    • Occurrence, nature, time to onset, duration, seriousness criteria, relationship to vaccination and outcome of serious adverse events (SAEs) during the whole study period
    • The occurrence of the following reactions (MedDRA Preferred Terms given in parentheses) following each injection will be more especially reported in subjects over 2 years of age (as defined for adults in 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
    * for subjects aged 9 to 17 years receiving the D0-D14 vaccination schedule, unsolicited AEs will only be collected up to 14 days after Vac1, and up to 21 days after Vac2.

    Immunogenicity:

    Immunogenicity will be assessed in all subjects receiving the D0-D21 vaccination schedule.

    • Anti-hemagglutinin (HA) antibody titers against the A/H5N1 strain using the hemagglutination inhibition method with horse erythrocytes (HIH) will be obtained from duplicate testing in the immunogenicity subset prior to Vac1, prior to Vac2 and 21 days after Vac2 (Vac2+21D), and summarized at the subject level by individual geometric mean (GM) of duplicates at each timepoint. The following endpoints will be derived:
    • Subjects with titer ≥8 (1/dilution) (1/dil) on Vac1, Vac2 and Vac2+21D
    • Individual titer ratios: Vac2/Vac1, Vac2+21D/Vac1 and Vac2+21D/Vac2
    • Proportion of subjects with titer ≥32 (1/dil) on Vac1, Vac2 and Vac2+21D
    • Seroconversion, i.e. for subjects with a pre-vaccination titer <8 (1/dil), post-vaccination titer ≥32 (1/dil), or significant increase, i.e. for subjects with a pre-vaccination titer ≥8 (1/dil), ≥4-fold increase of the titer post-vaccination, from Vac1 to Vac2, from Vac1 to Vac2+21D

    • Neutralizing antibody titer using the seroneutralization (SN) method will be obtained from single testing in the immunogenicity subset, prior to Vac1, prior to Vac2 and on Vac2+21days, and provided at the subject level at each timepoint. The following endpoints will be derived:
    • Subjects with titer ≥10 (1/dil) on Vac1, Vac2 and Vac2+21D
    • Individual titer ratios: Vac2/Vac1, Vac2+21D/Vac1 and Vac2+21D/Vac2
    • 2- and 4-fold increase from Vac1 to Vac2 and to Vac2+21
    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) 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 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.8.3 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 concerned12
    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
    Date of the last contact with a trial subject within the scope of 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 years
    E.8.9.1In the Member State concerned months7
    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 Yes
    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.1.1.5Children (2-11years) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects Aged ≥6 Months to <12 Years:
    Informed Consent Form signed by the parent(s) or other legal representative (and by an independent witness if required by local regulations), and Assent Form signed by subjects aged 8 to 11 years.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state350
    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 Decision2009-03-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-03-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-01-18
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