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    Summary
    EudraCT Number:2012-000138-20
    Sponsor's Protocol Code Number:115523
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-06-19
    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 ConcernedItaly - Italian Medicines Agency
    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
    Studio clinico multicentrico di Fase III, randomizzato, con osservatore in cieco, controllato verso placebo, volto a valutare l'efficacia profilattica, la sicurezza e l'immunogenicita' del vaccino contro l'herpes zoster gE/AS01B - di GlaxoSmithKline Biologicals somministrato per via intramuscolare, secondo una schedula a 2 dosi, a persone adulte che abbiano ricevuto un trapianto autologo di cellule staminali emopoietiche (HCT).
    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
    Studio per valutare l'efficacia, la sicurezza e l'immunogenicita' del vaccino GSK1437173A prodotto da GSK Biologicals contro l'Herpes Zoster
    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 BIOLOGICALS SA
    B.1.3.4CountryBelgium
    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 number44 20 8990 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 namevaccino Herpes Zoster GSK 1437173A
    D.3.2Product code HZ/su o 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 namegE Antigen
    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 solvent 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
    Vaccinazione contro il Fuoco di Sant'Antonio in pazienti adulti sottoposti a trapianto di cellule staminali
    E.1.1.1Medical condition in easily understood language
    Vaccination against shingles in adult recipients of autologous blood stem cells
    Vaccinazione contro Fuoco di Sant'Antonio in pazienti adulti con trapianto di cellule staminali
    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
    Valutare l'efficacia del vaccino gE/AS01B nel prevenire l'HZ nei pazienti con HCT autologo, di eta' &gt;= 18 anni.
    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.
    - Valutare l'efficacia del vaccino nel ridurre la durata totale del “peggior” dolore HZ-associato durante l'intero periodo di osservazione nei pazienti con HCT autologo,di eta' &gt;= 18 anni,con HZ confermato.- Valutare l'efficacia del vaccino nel ridurre le complicanze associate all'HZ confermato nei pazienti con HCT autologo,di eta' &gt;= 18 anni.- Valutare l'efficacia del vaccino nel prevenire la nevralgia post-erpetica (PHN) nei pazienti con HCT autologo,di eta' &gt;= 18 anni.- Valutare,in una sotto-coorte di soggetti,le risposte immuni di tipo umorale al vaccino in studio,somministrato secondo una schedula a due dosi.- Valutare la sicurezza e la reattogenicita' del vaccino nei pazienti con HCT autologo,di eta' &gt;= 18 anni.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - 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).
    - Soggetto che sia ritenuto dallo Sperimentatore capace e desideroso di osservare quanto richiesto dal protocollo di studio (per esempio: completare le schede diario, ritornare per le visite di follow-up, mantenere contatti regolari col centro clinico per permettere di essere valutato durante lo studio). - Consenso informato scritto fornito dal soggetto. - Soggetto di sesso femminile o maschile, di eta' &gt;= 18 anni al momento della prima vaccinazione. - Soggetto che ha ricevuto o ricevera' un HCT autologo nei 50-70 giorni precedenti la prima vaccinazione col vaccino/placebo dello studio, e per il quale non sono programmati altri HCTs (i pazienti che subiscono un HCT autologo “tandem” possono partecipare dopo il loro HCT finale). - Nello studio possono essere arruolate donne che non siano a rischio di concepimento, cioe' con legatura delle tube, isterectomia, ovariectomia o in post-menopausa. Donne potenzialmente fertili possono essere arruolate nello studio se: hanno praticato un'adeguata contraccezione da almeno 30 giorni prima della vaccinazione e risultano negative al test di gravidanza urinario eseguito il giorno stesso della vaccinazione e sono d'accordo di continuare l'adeguata contraccezione per l'intero periodo delle vaccinazioni e per 12 mesi dopo il completamento del ciclo vaccinale, cioe' fino al Mese 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).
    - Utilizzo di qualsiasi farmaco o vaccino sperimentale o non registrato, escluso il presente vaccino in studio, nei 30 giorni antecedenti la prima dose del vaccino/placebo in studio; o programmazione del loro uso durante lo studio clinico. Tuttavia e' consentito l'uso sperimentale di un prodotto registrato o non registrato volto a trattare la malattia, o una complicanza della malattia, per cui e' stato eseguito l'HCT. - Precedente vaccinazione contro l'HZ o contro la varicella nei 12 mesi precedenti la prima dose del vaccino/placebo in studio. - Somministrazione di un vaccino anti-HZ, anche sperimentale o non registrato, diverso dal vaccino in studio, programmata durante lo studio. - Presenza nella storia clinica di un episodio di HZ o di varicella nei 12 mesi precedenti la prima dose del vaccino/placebo in studio. - Storia di malattia allergica o di reazioni allergiche che potrebbero essere aggravate da un qualsiasi componente del vaccino o dei materiali/strumenti usati nello studio. - Terapia profilattica anti-virale che duri piu' di 6 mesi dopo il trapianto: la profilassi anti-virale post-trapianto dovra' essere somministrata secondo gli standard di cura locali e in base al giudizio clinico del medico sperimentatore, per quanto riguarda la durata, la scelta dell'agente anti-virale e il dosaggio. Possono essere arruolati nello studio i soggetti per i quali ci si aspetta che la terapia profilattica anti-virale duri per non piu' di 6 mesi dopo l'HCT. - Somministrazione/programmazione della somministrazione di un vaccino non previsto dal protocollo di studio nel periodo compreso tra l'HCT e i 30 giorni dopo l'ultima dose del vaccino/placebo in studio. Tuttavia e' permessa la somministrazione di vaccini registrati, inattivati e a sub-unita' (compresi i vaccini anti-influenzali inattivati e a sub-unita' e i vaccini coniugati anti-pneumococcici), fino a 8 giorni prima di ciascuna dose del vaccino in studio e/o almeno 14 giorni dopo ciascuna dose del vaccino in studio. - Infezione da HIV nella storia clinica del soggetto. - Soggetto in gravidanza o in allattamento. - Soggetto che, nel caso sia a rischio di concepimento, pianifichi una gravidanza o programmi d'interrompere le precauzioni contraccettive prima del Mese 13 (cioe' prima che sia trascorso un anno dall'ultima dose di vaccino/placebo in studio).
    E.5 End points
    E.5.1Primary end point(s)
    Occurrence of confirmed HZ cases: Incidence of confirmed HZ cases.
    Comparsa di casi confermati di HZ: Incidenza dei casi confermati di HZ dal Mese 0 fino alla fine dello studio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From Month 0 until study end (4 years approximately)
    Dal mese 0 alla fine dello studio (approssimativamente 4 anni).
    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. -Comparsa di eventi avversi seri (SAEs = Serious Adverse Events):comparsa e correlazione con la vaccinazione di tutti i SAEs dal Mese 0 al Mese 13, in tutti i soggetti; Comparsa di SAEs correlati col vaccino in studio/placebo dal Mese 0 fino alla fine dello studio, in tutti i soggetti; Comparsa di SAEs correlati con la partecipazione allo studio o con un concomitante farmaco/vaccino di GSK dalla Visita di Pre-vaccinazione fino alla fine dello studio, in tutti i soggetti; Comparsa di qualsiasi SAE fatale dalla Visita di Pre-vaccinazione fino alla fine dello studio, in tutti i soggetti. -Comparsa di AEs di specifico interesse: Comparsa e correlazione con la vaccinazione di qualsiasi pIMDs (potential Immune-Mediated Diseases = potenziali malattie immuno-mediate) dal Mese 0 al Mese 13, in tutti i soggetti; Comparsa di casi di ricaduta, cioe' della malattia per cui era stato eseguito l’HCT, dal Mese 0 fino alla fine dello studio.
    -Durata del “peggior” dolore HZ-associato: Durata del dolore HZ-associato di punteggio 3, o superiore a 3, nel questionario ZBPI (Zoster Brief Pain Inventory) dopo la comparsa di rash da HZ confermato, durante l'intero periodo di osservazione del dolore, nei soggetti con HZ confermato. -Comparsa di complicanze associate ad HZ confermato:Incidenza delle complicanze dell'HZ confermato, successive alla comparsa di HZ,dal Mese 0 fino alla fine dello studio. -Comparsa di PHN:Incidenza di PHN dal Mese 0 fino alla fine dello studio. -Concentrazioni degli anticorpi antigene-specifici in una sotto-coorte di soggetti:Concentrazioni degli anticorpi anti-gE misurate mediante ELISA in una sotto-coorte di soggetti al Mese 0, Mese 1, Mese 2, Mese 13 e Mese 25. -Comparsa di sintomi evocati, locali e generali: Comparsa e intensita' di qualsiasi sintomo evocato, locale, nei 7 giorni successivi ad ogni vaccinazione (Giorni 0-6), in tutti i soggetti; comparsa, intensita' e correlazione con la vaccinazione di qualsiasi sintomo evocato, generale, nei 7 giorni successivi ad ogni vaccinazione (Giorni 0-6), in tutti i soggetti. -Comparsa di eventi avversi non evocati (AEs = Adverse Events) Comparsa, intensita' e correlazione con la vaccinazione di eventi avversi non evocati, nei 30 giorni successivi ad ogni vaccinazione (Giorni 0-29), classificati secondo il Dizionario Medico per le Attivita' Regolatorie (MedDRA), in tutti i soggetti.
    E.5.2.1Timepoint(s) of evaluation of this end point
    From Month 0 until study end
    dal Mese 0 fino alla fine dello studio.
    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
    immunogenecity
    immunogenicita'
    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
    CON OSSERVATORE IN CIECO
    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 concerned9
    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
    Brazil
    Canada
    Hong Kong
    India
    Israel
    Japan
    Korea, Republic of
    Malaysia
    New Zealand
    Panama
    Russian Federation
    South Africa
    Taiwan
    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.
    Lo studio si concludera' quando saranno realizzate le condizioni per l'analisi finale di efficacia, quando sara' completato il FU di ciascun caso sospetto di HZ verificatosi entro, e comprendente, la data di cut-off per l'analisi finale.
    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.1.1Number of subjects for this age range: 0
    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 state92
    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.
    I pazienti continueranno a ricevere la terapia standard per la patologia per cui hanno ricevuto trapianto di cellule staminali come prescritto dal loro medico curante
    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 Decision2012-05-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-04-18
    P. End of Trial
    P.End of Trial StatusCompleted
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