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    Summary
    EudraCT Number:2012-000138-20
    Sponsor's Protocol Code Number:115523
    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:2012-04-17
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2012-000138-20
    A.3Full title of the trial
    A phase III, randomised, observer-blind, placebo-controlled, multicentre, clinical trial to assess the prophylactic efficacy, safety, and immunogenicity of GSK Biologicals? herpes zoster gE/AS01B candidate vaccine when administered intramuscularly on a two-dose schedule to adult autologous haematopoietic stem cell transplant (HCT) recipients
    Ensayo clínico fase III, aleatorizado, observador-ciego, controlado con placebo, multicéntrico, para evaluar la eficacia profiláctica, seguridad e inmunogenicidad de la vacuna candidata frente a Herpes Zóster gE/AS01B de GSK Biologicals cuando se administra por vía intramuscular en una pauta de dos dosis a adultos receptores de trasplante autólogo de progenitores hematopoyéticos (TPH).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate efficacy, safety, and immunogenicity of GSK Biologicals? Herpes Zoster vaccine GSK1437173A
    Estudio observador-ciego para evaluar la eficacia, seguridad e inmunogenicidad de la vacuna Herpes Zóster GSK1437173A de GSK Biologicals
    A.3.2Name or abbreviated title of the trial where available
    ZOSTER-002
    ZOSTER-002
    A.4.1Sponsor's protocol code number115523
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGlaxoSmithKline SA
    B.1.3.4CountrySpain
    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 supportGlaxoSmithKline Biologicals
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Biologicals
    B.5.2Functional name of contact pointClinical Disclosure Advisor
    B.5.3 Address:
    B.5.3.1Street AddressRue de l?Institut, 89
    B.5.3.2Town/ cityRixensart
    B.5.3.3Post code1330
    B.5.3.4CountryBelgium
    B.5.4Telephone number44208990 4466
    B.5.6E-mailGSKClinicalSupportHD@gsk.com
    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 namevacuna Herpes Zoster GSK 1437173A
    D.3.2Product code HZ/su or gE/AS01B
    D.3.4Pharmaceutical form Powder and solvent for suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codegE
    D.3.9.3Other descriptive nameAntigeno gE
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Yes
    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 placeboPowder and solution for solution for injection
    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
    Vaccination against herpes zoster (HZ) in adult autologous HCT recipients
    Vacunación frente a herpes zoster en en adultos receptores de TPH autólogo
    E.1.1.1Medical condition in easily understood language
    Vaccination against shingles in adult recipients of autologous blood stem cells
    Vacunación frente a herpes zoster en adultos receptores de trasplante autólogo de celulas madre o progenitores hematopoyéticos
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10019974
    E.1.2Term Herpes zoster
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    ?To evaluate VE in the prevention of HZ in autologous HCT recipients 18 years of age and older
    Evaluar la EV en la prevención del HZ en receptores de un TPH autólogo de 18 o más años de edad.
    E.2.2Secondary objectives of the trial
    ?To evaluate VE in reducing the total duration of ?worst? HZ-associated pain over the entire pain reporting period in autologous HCT recipients 18 years of age and older with confirmed HZ;
    ?To evaluate VE in the reduction of confirmed HZ-associated complications in autologous HCT recipients 18 years of age and older;
    ?To evaluate VE in the prevention of Postherpetic Neuralgia (PHN) in autologous HCT recipients 18 years of age and older;
    ?To evaluate humoral immune responses to the study vaccine, when administered according to a 2-dose schedule in a sub-cohort of subjects;
    ?To evaluate vaccine safety and reactogenicity in autologous HCT recipients 18 years of age and older.
    ?Evaluar la EV en la disminución de la duración total del dolor ?máximo? asociado al HZ durante todo el periodo de notificación del dolor en receptores de un TPH autólogo de 18 o más años de edad con HZ confirmado;
    ?Evaluar la EV en la reducción de las complicaciones asociadas en pacientes receptores de un TPH autólogo de 18 o más años de edad con HZ confirmado ;
    ?Evaluar la EV en la prevención de la NPH en receptores de un TPH autólogo de 18 o más años de edad;
    ?Evaluar la respuesta inmunitaria humoral a la vacuna del estudio, administrada según una pauta de 2 dosis, en una subcohorte de sujetos;
    ?Evaluar la seguridad y la reactogenicidad de la vacuna en receptores de un TPH autólogo de 18 años de edad en adelante.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Study entry (enrolment) occurs at the Pre-vaccination visit.
    ?Subjects who the investigator believes can and will comply with the requirements of the protocol ;
    ?Written informed consent obtained from the subject;
    ?A male or female aged 18 years or older at the time of the first vaccination with the study vaccine/placebo.
    ?Has undergone or will undergo autologous HCT within 50-70 days prior to the first vaccination with the study vaccine/placebo, and there are no plans for additional HCTs;
    ?Female subjects of non-childbearing potential may be enrolled in the study;
    For this study population, non-childbearing potential is defined as current tubal ligation, hysterectomy, ovariectomy or post-menopause.
    OR
    Female subjects of childbearing potential may be enrolled in the study, if the subject has practiced adequate contraception for 30 days prior to vaccination with the study vaccine/placebo, and has a negative pregnancy test on the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 12 months after completion of the vaccination series (i.e., until Month 13).
    La inclusión en el estudio (reclutamiento) tiene lugar en la visita de prevacunación.
    ?Sujetos que, en opinión del investigador, puedan y vayan a cumplir los requisitos del protocolo
    ?Obtención del consentimiento informado por escrito del sujeto;
    ?Varón o mujer con 18 años de edad o más en el momento de la primera vacunación con la vacuna del estudio/placebo.
    ?El sujeto se ha sometido o se va a someter a un TPH autólogo en los 50 70 días anteriores a la primera vacunación con la vacuna del estudio/placebo y no está previsto que vaya a recibir TPH adicionales (los receptores de un TPH tándem autólogo podrán participar después del TPH final);
    ?Las mujeres con ausencia de capacidad reproductiva podrán participar en el estudio;En la población de este estudio, la ausencia de capacidad reproductiva se define como la presencia actual de ligadura de trompas, histerectomía, ovariectomía o posmenopausia.
    O
    Las mujeres con capacidad reproductiva podrán participar en el estudio si han utilizado anticoncepción adecuada durante 30 días antes de la vacunación con la vacuna del estudio/placebo, presentan una prueba de embarazo negativa el día de la vacunación y han accedido a seguir usando anticoncepción adecuada durante todo el período de tratamiento y durante 12 meses después de la finalización de la pauta de vacunación (es decir, hasta el mes 13).
    E.4Principal exclusion criteria
    ?Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine/placebo, or planned use during the study period. However, the investigational use of a registered or non-registered product to treat the subject?s underlying disease for which the HCT was undertaken, or a complication of the underlying disease, is allowed;
    ?Previous vaccination against HZ or varicella within the 12 months preceding the first dose of study vaccine/placebo;
    ?Planned administration during the study of a HZ vaccineother than the study vaccine;
    ?Occurrence of a varicella or HZ episode by clinical history within the 12 months preceding the first dose of study vaccine/placebo;
    ?History of allergic disease or reactions likely to be exacerbated by any component of the vaccine or study material and equipment;
    ?Prophylactic antiviral therapy expected to last more than 6 months after transplantation; .
    ?Administration and/or planned administration of a vaccine not foreseen by the study protocol between HCT and 30 days after the last dose of study vaccine/placebo. However, licensed non-replicating vaccines may be administered up to 8 days prior to dose 1and/or 2, and/or at least 14 days after any dose of study vaccine/placebo;
    ?HIV infection by clinical history;
    ?Pregnant or lactating female;
    ?Female planning to become pregnant or planning to discontinue contraceptive precautions (if of childbearing potential) before Month 13 (i.e., one year after the last dose of study vaccine/placebo).
    ?Uso de cualquier producto en investigación o no registrado (fármaco o vacuna) distinto de la vacuna del estudio en los 30 días anteriores a la primera dosis de la vacuna del estudio/placebo, o uso previsto durante el período del estudio. Sin embargo, se permite el uso experimental de un producto autorizado o no autorizado para el tratamiento de la enfermedad subyacente del sujeto para la que se realizó el TPH o de una complicación de dicha enfermedad subyacente;
    ?Vacunación previa frente al HZ o varicela en los 12 meses previos a la primera dosis de la vacuna del estudio/placebo;
    ?Administración prevista durante el estudio de una vacuna frente a HZ distinta de la vacuna del estudio;
    ?Episodio de varicela o de HZ documentado en la historia clínica en los 12 meses previos a la primera dosis de la vacuna del estudio/placebo;
    ?Antecedentes de enfermedad o de reacciones alérgicas que puedan exacerbarse por cualquiera de los componentes de la vacuna o del material y/o del equipamiento del estudio;
    ?Tratamiento antiviral profiláctico con una duración prevista de más de 6 meses después del trasplante;
    (1) Tratamiento antiviral profiláctico administrado después del TPH de conformidad con las normas asistenciales locales según el criterio del investigador (duración, elección del fármaco antiviral y dosis del fármaco antiviral). Podrán participar los sujetos cuyo tratamiento antiviral profiláctico vaya a durar previsiblemente 6 meses o menos después del TPH.
    ?Administración o administración prevista de una vacuna no contemplada en el protocolo del estudio entre el TPH y 30 días después de la última dosis de la vacuna del estudio/placebo. Sin embargo, pueden administrarse vacunas autorizadas sin capacidad de replicación hasta 8 días antes de la dosis 1 y/o 2, y/o al menos 14 días después de cualquier dosis de la vacuna del estudio/placebo; (Enmienda 22 Feb 2012)
    ?Infección por el VIH documentada en la historia clínica;
    ?Mujeres embarazadas o en período de lactancia;
    ?Mujeres que tengan intención de quedarse embarazadas o que tengan previsto interrumpir el uso de anticonceptivos (si tienen capacidad reproductiva) antes del mes 13 (es decir, un año después de la última dosis de la vacuna del estudio/placebo).
    E.5 End points
    E.5.1Primary end point(s)
    Occurrence of confirmed HZ cases:
    Incidence of confirmed HZ cases.
    Aparición de casos de HZ confirmados
    Incidencia de casos de HZ confirmados
    E.5.1.1Timepoint(s) of evaluation of this end point
    From Month 0 until study end (4 years approximately)
    Del mes 0 hasta fin del estudio (4 años aproximadamente)
    E.5.2Secondary end point(s)
    1. Duration of ?worst? HZ-associated pain:Duration of HZ-associated pain rated as 3 or greater on the ?worst pain? Zoster Brief Pain Inventory (ZBPI) question, following the onset of a confirmed HZ rash over the entire pain reporting period in subjects with confirmed HZ.
    2. Occurrence of confirmed HZ-associated complications: Incidence of confirmed HZ complications following the onset of HZ.
    3. Occurrence of PHN: Incidence of PHN.
    4. Antigen-specific Antibody (Ab) concentrations in a sub-cohort of subjects:Anti- gE Ab concentrations as determined by ELISA in a sub-cohort of subjects.
    5. Occurrence of solicited local and general symptoms:-Occurrence and intensity of each solicited local symptom in all subjects
    -Occurrence, intensity and relationship to vaccination of each solicited general symptom in all subjects.
    6. Occurrence of unsolicited adverse events (AEs):Occurrence, intensity and relationship to vaccination of unsolicited AEs, according to the Medical Dictionary for Regulatory Activities (MedDRA) classification in all subjects.
    7. Occurrence of Serious Adverse Events (SAEs):- Occurrence and relationship to vaccination of all SAEs in all subjects;
    -Occurrence of SAEs related to the GSK study vaccine/placebo in all subjects;
    -Occurrence of SAEs related to study participation or to a concurrent GSK medication/vaccine in all subjects;
    -Occurrence of any fatal SAEs in all subjects.
    8. Occurrence of AEs of specific interest:Occurrence of AEs of specific interest: -Occurrence and relationship to vaccination of any potential Immune Mediated Diseases (pIMDs)
    -Occurrence of relapse cases in all subjects.
    1.Duración del dolor ?máximo? asociado al HZ:Duración del dolor asociado al HZ puntuado como 3 o más en la pregunta sobre ?dolor máximo? del Cuestionario breve de dolor por zóster (ZBPI), tras la aparición de un rash herpético confirmado durante todo el periodo de notificación del dolor en sujetos con HZ confirmado;
    2.Aparición de complicaciones asociadas al HZ confirmado:Incidencia de complicaciones asociadas al HZ confirmado después de la aparición del HZ 3.Aparición de NPH: Incidencia de NPH 4.Concentraciones de anticuerpos frente a antígenos específicos en una subcohorte de sujetos: Concentraciones de anticuerpos anti gE, determinadas mediante ELISA, en una subcohorte de sujetos 5.Aparición de síntomas locales y generales solicitados: Aparición e intensidad de cada síntoma local solicitado rn todos los sujetos;
    Aparición, intensidad y relación con la vacunación de cada síntoma general solicitado en todos los sujetos;
    6.Aparición de acontecimientos adversos (AA) no solicitados: Aparición, intensidad y relación con la vacunación de los AA no solicitados, según la clasificación del Diccionario médico para actividades de registro (MedDRA) en todos los sujetos;
    7.Aparición de acontecimientos adversos graves (AAG): Aparición y relación con la vacunación de todos los AAG en todos los sujetos; Aparición de AAG relacionados con la vacuna del estudio/placebo de GSK en todos los sujetos; Aparición de AAG relacionados con la participación en el estudio o con un medicamento/vacuna concurrente de GSK en todos los sujetos;
    Aparición de cualquier AAG mortal en todos los sujetos 8. aparición de AA de interés especial: Aparición y relación causal con la vacunación de cualquier enfermedad potencialmente mediada por el sistema inmune (pIMDs) en todos los sujetos;
    Aparición de casos de recidiva en todos los sujetos.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. From Month 0 until study end (4 years approximately), from the onset of a confirmed HZ rash over the entire pain reporting period.
    2. From Month 0 up until study end (4 years approximately.
    3. From Month 0 until study end (4 years approximately).
    4. At Month 0, Month 1, Month 2, Month 13 and Month 25.
    5. Within 7 days (Days 0-6) after each vaccination.
    6. During 30 days (Days 0-29) after each vaccination.
    7. From the Pre-vaccination visit (Up to 110 days prior Month 0) until study end (4 years approximately).
    8. From Month 0 until study end (4 years, approximately).
    1. Desde mes 0 hasta fin del estudio (4 años aproximadamente) tras aparición de un rash herpético confirmado durante todo el periodo que persiste el dolor
    2. Del mes 0 hasta fin del estudio (4 años aproximadamente
    3. Del mes 0 hasta fin del estudio (4 años aproximadamente
    4. en el mes 0, mes 1, mes 2, mes 13 y mes 25
    5. En los 7 días (días 0-6) después de cada vacunación
    6. Durante 30 días (días 0-29) después de cada vacunación
    7. Desde la visita de prevacunación (hasta 110 días antes del mes 0) hasta la finalización del estudio (4 años aproximadamente
    8. Desde el mes 0 hasta la finalización del estudio (4 años aproximadamente)
    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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    observador ciego
    Observer-blind
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned18
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA91
    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
    Australia
    Austria
    Belgium
    Brazil
    Bulgaria
    Canada
    Czech Republic
    Estonia
    Finland
    France
    Germany
    Greece
    Hong Kong
    India
    Israel
    Italy
    Japan
    Korea, Republic of
    Malaysia
    Netherlands
    New Zealand
    Panama
    Poland
    Romania
    Russian Federation
    South Africa
    Spain
    Sweden
    Taiwan
    Turkey
    United Kingdom
    United States
    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
    Study end will take place when the conditions for final triggered analysis are met and follow-up is completed for each suspected HZ case that occurs up to and including the cut-off date for final analysis.
    La conclusión del estudio tendrá lugar cuando se cumplan las condiciones del análisis final y el seguimiento se haya completado para cada caso sospechoso de HZ que ocurra hasta la fecha de corte del análisis (incluyendo ésta).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    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 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.1.2.1Number of subjects for this age range: 1105
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 369
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    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 state230
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 809
    F.4.2.2In the whole clinical trial 1474
    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)
    For their underlying condition, the subjects will continue to receive standard care, as provided by their physician.
    Para las enfermedades subyacentes, los sujetos continuarán recibiendo el tratamiento estandar proporcionado por su médico
    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 Decision2012-06-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-02-01
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