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    Summary
    EudraCT Number:2009-013858-32
    Sponsor's Protocol Code Number:GPF09
    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:2009-07-13
    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 number2009-013858-32
    A.3Full title of the trial
    Immunogenicity and Safety of Multiple Formulations of an Intramuscular Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With and Without Adjuvant in Healthy European Subjects Aged 6 to 35 Months
    A.3.2Name or abbreviated title of the trial where available
    Immunogenicity and safety of different formulations of intramuscular swine-origin influenza vaccine
    A.4.1Sponsor's protocol code numberGPF09
    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 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.3.8INN - Proposed INNInfluenza 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 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 nameSwine A/H1N1 Influenza Vaccine (split virion, inactivated, adjuvanted with AF03)
    D.3.2Product code 452
    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.3.8INN - Proposed INNInfluenza 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: 3
    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 nameSwine A/H1N1 Influenza Vaccine (split virion, inactivated, adjuvanted with AF03)
    D.3.2Product code 452
    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.3.8INN - Proposed INNInfluenza 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 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.IMP: 4
    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 holderBelgium Sanofi Pasteur MSD
    D.2.1.2Country which granted the Marketing AuthorisationFinland
    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 nameTrivalent influenza vaccine (split virion, inactived), NH 2010-2011 formulation
    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 nameA/California/7/2009 (H1N1)-derived strain used NYMC X-179A
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameA/Perth/16/2009 (H3N2)-like strain used NYMC X-187 derived from A/Victoria/210/2009
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameB/Brisbane/60/2008
    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 6 to 35 months 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 each candidate vaccine 21 days after each vaccination by hemagglutination inhibition (HAI) and seroneutralization (SN)
    testing in all subjects.
    • To describe the antibody persistence eight months (M8) after the first vaccine administration using HAI method in a subset of subjects who received two half doses of either the 15 μg HA or 3.8 μg HA + AF03 vaccine (amendment 2).
    • To describe the safety profiles (injection site reactions, and systemic events) of each candidate vaccine during the 21 days following each vaccination, and serious adverse events throughout the study in all subjects
    •To describe the immune response against the A/H1N1 strain using the HAI method 21 days after last vaccination with the 2010-2011 NH seasonal TIV administered 13 months after the first vaccination in a subset of subjects who received two half-doses of either the 15 µg HA or 3.8 µg HA + AF03 A/H1N1 influenza vaccines as primary series (amendment 3).
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All subjects
    1) Aged 6 to 35 months on the day of inclusion
    2) Informed consent form has been signed and dated by the parent(s) or other legally
    acceptable representative
    3) Subject and parent/legal representative are able to attend all scheduled visits and
    to comply with all trial procedures
    4) Completion of vaccination according to the national immunization schedule
    Subjects ≥6 to <24 months of age
    5) Born at full term of pregnancy (≥37 weeks) and with a birth weight ≥2.5 kg

    At V05 (M8) for antibody persistence assessment (amendment 2)
    6) Having received two half doses of the 15 μg HA vaccine or of the
    3.8 μg HA + AF03 vaccine
    7) Addendum 1 to Informed Consent Form has been signed and dated by the
    parent(s) or other legally acceptable representative

    At V06, for subjects eligible for the Ab persistence evaluation who will receive the TIV (amendment 3):
    8)Addendum 2 to Informed Consent Form has been signed by the subject’s parents/legal representative.
    E.4Principal exclusion criteria
    All subjects
    1) Participation in another clinical trial investigating a vaccine, drug, medical device,
    or medical procedure in the 4 weeks preceding the first trial vaccination
    2) Planned participation in another clinical trial during the present trial period
    3) Receipt of any vaccine in the 4 weeks preceding the first trial vaccination
    4) Planned receipt of any vaccine prior to the Day 42 blood sample
    5) Receipt of blood or blood-derived products in the past 3 months, which might
    interfere with assessment of the immune response
    6) 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)
    7) Seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B antigen, or
    Hepatitis C as reported by parents/legal representative
    8) 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
    9) Thrombocytopenia, contraindicating IM vaccination as reported by parents/legal
    representative
    10) Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,
    contraindicating IM vaccination
    11) Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion
    12) Family members of the Investigator or of the employees of the study center
    13) Previous participation in a trial investigating a vaccine with the swine-origin
    A/H1N1 influenza strain
    14) Confirmed infection with the swine-origin A/H1N1 influenza strain (different
    from the seasonal strain) in 2009
    15) Febrile illness (temperature ≥38.0°C) or moderate or severe acute illness/infection
    on the day of vaccination, according to Investigator judgment
    16) Receipt of any allergy shots and/or seasonal allergy medication in the 7-day
    period prior to enrollment (vaccination), or scheduled to receive any allergy shots
    and/or seasonal allergy medication in the 7-day period after enrollment
    (vaccination)
    Subjects ≥6 to <24 months of age
    17) History of seizures
    At V05 (M8), for antibody persistence assessment (amendment 2)
    18) Subjects who received, in the context of a pandemic immunization program,
    another A/H1N1 pandemic influenza vaccine than the Investigational Medicinal
    Products
    E.5 End points
    E.5.1Primary end point(s)
    A) Immunogenicity

    * Primary Vaccination Series and Antibody Persistence (amendment 2)

    HAI antibody (Ab) titers against the swine origin A/H1N1 strain measured with HAI method will be expressed as described below:
    • HAI Ab titers will be obtained on D0, D21, and D42. The following endpoints will be derived:
    • Individual titers ratios D21/D0, D42/D0, and D42/D21
    • Subjects with HAI Ab titer ≥40 (1/dilution [dil]) on D0, D21, and D42
    • Subjects with seroconversion or significant increase in HAI Ab titer, from D0 to D21 and from D0 to D42:
    - 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, D21, and D42
    HAI Ab titers will also be obtained at M8 for antibody persistence evaluation. The following endpoints will be derived: Subjects with HAI Ab titer ≥10 and≥40 (1/dil) (amendment 2).
    Following HAI testing neutralizing Ab titers will be measured with the seroneutralization (SN) method and expressed as described below:
    • Neutralizing Ab titers will be obtained on D0, D21, and D42. The following endpoints will be derived:
    • Individual titers ratios D21/D0, D42/D0, and D42/D21
    • Two- and four-fold increase of titers from D0 to D21, D0 to D42, and D21 to D42
    • Subjects with detectable neutralizing Abs, i.e. with a titer ≥10 (1/dil), on D0, D21, and D42
    • Subjects with neutralizing Abs titer ≥20 and ≥40 (1/dil), on D0, D21, and D42

    * Vaccination With the NH Seasonal TIV (amendment 3):

    HAI Ab titers against the A/H1N1 influenza strain contained in the 2010-2011 NH seasonal TIV measured with the HAI method will be expressed as described below:
    • HAI Ab titers will be obtained before (pre-TIV) and 21 days after last vaccination (post-TIV). The following endpoints will be derived:
    • Individual titers ratios post-TIV/pre-TIV
    • Subjects with HAI Ab titer ≥40 (1/dil) pre-TIV and post-TIV
    • Subjects with seroconversion or significant increase in HAI Ab titer, from pre-TIV to post-TIV:
    - Seroconversion for subjects with a pre-vaccination titer <10 (1/dil), 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), pre- and post TIV


    B) Safety

    • Occurrence of unsolicited adverse event (AE) reported in the 30 minutes after each/any injection (for primary series and TIV)
    • Occurrence of solicited (prelisted in the subject diary and eCRF) injection site reactions and systemic reactions within 7 days following each/any injection (for primary series and TIV)
    • Occurrence of unsolicited (spontaneously reported) AEs within 21 days following each/any injection (for primary series and TIV)
    • Occurrence of the following reactions (Medical Dictionary for Regulatory Activities [MedDRA] Preferred Terms given in parentheses) in the 3 days following each injection in subjects ≥24 months (as defined for adults 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 SAEs including adverse events of special interest (AESIs) within the 21 days following each/any vaccination (for primary series and TIV), and up to the end of the trial.
    • Occurrence of biochemical or hematological test results of any grade and of biochemical or hematological test results clinically significant based on Investigator decision at pre-vaccination and 7 days after the first vaccination.
    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) 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.8.3 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 concerned15
    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 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 months16
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months16
    E.8.9.2In all countries concerned by the trial days0
    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) No
    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 No
    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
    ICF signed by the subject's the parent(s)/legal representative (and by an independent witness if required by local regulations)
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state400
    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 Decision2009-09-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-08-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-01-05
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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