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    Summary
    EudraCT Number:2013-001231-51
    Sponsor's Protocol Code Number:GQM05
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-04-04
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2013-001231-51
    A.3Full title of the trial
    Efficacy and Immunogenicity Study of Quadrivalent Influenza Vaccine Administered via the Intramuscular Route in Healthy Children Aged 6 to 35 Months
    Estudio de eficacia e inmunogenicidad de una vacuna antigripal tetravalente administrada por vía intramuscular a niños sanos de 6 a 35 meses
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Immunogenicity Study of Quadrivalent Influenza Vaccine Administered via the Intramuscular Route in Healthy Children Aged 6 to 35 Months
    Estudio de eficacia e inmunogenicidad de una vacuna antigripal tetravalente administrada por vía intramuscular a niños sanos de 6 a 35 meses
    A.4.1Sponsor's protocol code numberGQM05
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1127-7504
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/203/2012
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSanofi Pasteur
    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 supportSanofi Pasteur
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Infantil La Paz
    B.5.2Functional name of contact pointCoordinating Investigator
    B.5.3 Address:
    B.5.3.1Street AddressCastellana 261
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28046
    B.5.3.4CountrySpain
    B.5.4Telephone number91 727 70 89
    B.5.5Fax number91 358 05 03
    B.5.6E-mailceliac.diaz@salud.madrid.org
    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.3.2Product code 481
    D.3.4Pharmaceutical form Suspension for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNInfluenza virus (split virion, inactivated) A/H1N1-like strain
    D.3.9.3Other descriptive nameINFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)
    D.3.9.4EV Substance CodeSUB12066MIG
    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.3.8INN - Proposed INNInfluenza virus ( split virion, inactivated) A/H3N2-like strain
    D.3.9.3Other descriptive nameINFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)
    D.3.9.4EV Substance CodeSUB12066MIG
    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.3.8INN - Proposed INNInfluenza virus ( split virion, inactivated) B-like strain (Victoria lineage)
    D.3.9.3Other descriptive nameINFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)
    D.3.9.4EV Substance CodeSUB12066MIG
    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.3.8INN - Proposed INNInfluenza virus ( split virion, inactivated) B-like strain (Yamagata lineage)
    D.3.9.3Other descriptive nameINFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)
    D.3.9.4EV Substance CodeSUB12066MIG
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 Yes
    D.2.1.1.1Trade name Vaxigrip
    D.2.1.1.2Name of the Marketing Authorisation holderSpain Sanofi Pasteur MSD SA
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameVaxigrip
    D.3.2Product code 314
    D.3.4Pharmaceutical form Suspension for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNInfluenza virus (split virion, inactivated) A/H1N1-like strain
    D.3.9.3Other descriptive nameINFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)
    D.3.9.4EV Substance CodeSUB12066MIG
    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.3.8INN - Proposed INNInfluenza virus ( split virion, inactivated) A/H3N2-like strain
    D.3.9.3Other descriptive nameINFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)
    D.3.9.4EV Substance CodeSUB12066MIG
    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.3.8INN - Proposed INNInfluenza virus ( split virion, inactivated) B-like strain (Victoria or Yamagata lineage)
    D.3.9.3Other descriptive nameINFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)
    D.3.9.4EV Substance CodeSUB12066MIG
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 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 Yes
    D.2.1.1.1Trade name Vaxigrip
    D.2.1.1.2Name of the Marketing Authorisation holderSpain Sanofi Pasteur MSD SA
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameVaxigrip
    D.3.2Product code 314
    D.3.4Pharmaceutical form Suspension for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNInfluenza virus (split virion, inactivated) A/H1N1-like strain
    D.3.9.3Other descriptive nameINFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)
    D.3.9.4EV Substance CodeSUB12066MIG
    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.3.8INN - Proposed INNInfluenza virus ( split virion, inactivated) A/H3N2-like strain
    D.3.9.3Other descriptive nameINFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)
    D.3.9.4EV Substance CodeSUB12066MIG
    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.3.8INN - Proposed INNInfluenza virus ( split virion, inactivated) B-like strain (Victoria or Yamagata lineage)
    D.3.9.3Other descriptive nameINFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)
    D.3.9.4EV Substance CodeSUB12066MIG
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prevention of influenza infection in children aged 6 to 35 months
    Profilaxis de la gripe en niños de 6 a 35 meses de edad
    E.1.1.1Medical condition in easily understood language
    Active immunisation of children aged 6 to 35 months against influenza infection
    Inmunización activa de niños de 6 a 35 meses contra contra la gripe
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10022001
    E.1.2Term Influenza (epidemic)
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the efficacy of QIV as compared to non-influenza vaccine
    Demostrar la eficacia de QIV en comparación con los que no hayan sido vacunados previamente contra la gripe.
    E.2.2Secondary objectives of the trial
    Efficacy
    Immunogenicity (immunogenicity subset):
    ? To demonstrate the non-inferiority of immune response induced by QIV compared with TIV
    ? To demonstrate the superiority of immune response (HAI) to each B strain in QIV compared with the TIV that does not contain the corresponding B strain.
    ? To assess immune response of a booster dose of QIV one year after 2 doses of QIV
    ? To describe the immune response (by HAI, SN method and ELLA method).
    Safety:
    ? To describe the safety profile of QIV compared to TIV.
    Correlates of Protection:
    ? To assess potential immunologic correlates of protection.
    inmunogenicidad ( inmunogenicidad subgrupo):
    - Demostrar la no inferioridad de la respuesta inmunitaria a la vacuna
    QIV respecto de la vacuna TIV
    - Demostrar la superioridad de las respuestas de anticuerpos (IHA) a
    cada cepa B de la vacuna QIV en comparación con la vacuna TIV que no contiene la cepa B correspondiente.
    - Describir la respuesta inmunitaria inducida por una dosis de vacuna
    QIV administrada un año después de 2 dosis de vacuna QIV.
    -Describir la respuesta inmunitaria ( mediante los metodos IHA, SN y
    anti-NA)
    Seguridad:
    - Describir el perfil de seguridad de QIV comparado con TIV
    Correlatos de protección
    - Describir posibles correlatos de protección inmunológica.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Healthy children aged 6 to less than 36 months not previously vaccinated against influenza.
    Niños sanos de 6 a menos de 36 meses, no vacunados previamente
    contra la gripe.
    E.4Principal exclusion criteria
    ?At risk? children according to the definition from the Advisory Committee on Immunization Practices (ACIP).
    Niños " en riesgo" según definición del Advisory Committee on
    Immunization Practices (ACIP).
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of laboratory confirmed influenza (at least 14 days after last vaccination) caused by any influenza viral types/subtypes, in association with a protocol-defined Influenza Like Illness (ILI) with QIV as compared to non-influenza vaccine
    Aparición de una ILI con confirmación positiva por laboratorio ( al
    menos 14 días después de la última vacunación) causada por cualquier tipo/subtipo de virus de la gripe, en asociación con ILI definido en protocolo con QIV en relación con no vacunados contra la gripe
    E.5.1.1Timepoint(s) of evaluation of this end point
    ? 14 days after last vaccination
    >= 14 días tras última vacunación
    E.5.2Secondary end point(s)
    Efficacy:
    Incidence of laboratory-confirmed influenza illness due to any of the 4 vaccine strains, in association with a protocol-defined ILI with QIV group as compared to non-influenza vaccine group.
    Immunogenicity:
    Immune responses in all groups for each influenza strain (HAI, SN, anti-NA) on D0 and D56 (all patients for HAI, subset of patients (at least 80 per group for SN and at least 50 per group for anti-NA)
    Comparison of immune response at Day 56 between QIV and TIV (common strains and B strains not in TIV)
    Immune response after booster administration
    Safety: AE and SAEs throughout the study
    Correlates of Protection: exploration of immune responses in relation to occurrences of laboratory confirmed influenza, 28 days after the last vaccination.
    Eficacia:
    Aparición de una ILI con confirmación positiva por laboratorio, causada
    por cualquiera de las 4 cepas de la vacuna, asociada a ILI definido en
    protocolo con QiV en relación con los no vacunados contra la gripe.
    Inmunogenicidad:
    Respuestas inmunes en todos los grupos para cada cepa de gripe (IHA,
    SN y anti-NA) en los días 0 y 56. ( todos los pacientes IHA, subgrupo de
    pacientes ( al menos 80 por grupo para SN y al menos 50 por grupo para
    anti-NA)
    Comparación de la respuesta inmune el día 56 entre QIV y TIV ( cepas
    comunes y cepas B sin TIV)
    Respuesta inmune tras administración dosis de refuerzo
    Seguridad: AA y AAG a lo largo del estudio
    Correlato de protección: Explorar las respuestas inmunes en relación con gripe confirmada por PCR, 28 días después de la última vacunación.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy: ? 14 days after last vaccination

    Immunogenicity: 0 and 28 days after last vaccination (D56)

    Safety:
    - unsolicited AEs in the 30 min after each/any injection
    - solicited ARs within 7days following each/any injection
    - unsolicited AEs within 28days following each/any injection
    - EMA criteria: in the 3 days following each/any injection
    Eficacia: >= 14 días tras última vacunación.
    Inmunogenicidad: 0 y 28 días tras última vacunación ( D56)
    Seguridad:
    - AA no esperados en los 30 minutos posteriores a cada/cualquier
    injección.
    - RA en los 7 dias posteriores a a cada/cualquier injección.
    - AA no esperados en los 28 días posteriores a cada/cualquier injección.
    - Criterio EMA: en los 3 dias posteriores a a cada/cualquier injección
    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 Yes
    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
    Inmunogenicidad
    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 No
    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 Yes
    E.8.1.7.1Other trial design description
    observer-blind (except for TIV groups which will be open-label)
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA39
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    France
    Greece
    Italy
    Dominican Republic
    Germany
    Honduras
    Spain
    Philippines
    South Africa
    Turkey
    E.8.7Trial has a data monitoring committee Yes
    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
    LVLS
    Última visita del último paciente
    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 months20
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months20
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 9000
    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.1.1.4.1Number of subjects for this age range: 4500
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 4500
    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 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 state633
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2383
    F.4.2.2In the whole clinical trial 9000
    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)
    None
    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 Decision2014-06-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-07-27
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