Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2012-005059-18
    Sponsor's Protocol Code Number:116886
    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:2018-02-28
    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 number2012-005059-18
    A.3Full title of the trial
    A Phase III, randomised, observer-blind, placebo-controlled, multicentre
    clinical study to assess the immunogenicity and safety of GSK Biologicals'
    HZ/su candidate vaccine when administered intramuscularly on a 0- and 1-
    to 2-months schedule to adults ≥ 18 years of age with renal transplant.
    Studio di fase III, randomizzato, multicentrico, con osservatore in cieco, controllato verso placebo, per valutare l’immunogenicità e la sicurezza del vaccino HZ/su di GSK Biologicals quando somministrato per via intramuscolare in una schedula 0 e 1 – 2 mesi in adulti con età ≥ 18 anni con trapianto renale.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immunogenicity and safety of GlaxoSmithKline Biologicals' Herpes Zoster
    subunit (HZ/su) vaccine in adults 18 years of age or older with renal
    transplant.
    Immunogenicità e sicurezza del vaccino a subunità per Herpes zoster di GlaxoSmithKline Biological's somministrato in adulti con età ≥ 18 con trapianto renale.
    A.3.2Name or abbreviated title of the trial where available
    ZOSTER-041
    ZOSTER-041
    A.4.1Sponsor's protocol code number116886
    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
    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 number00442089904466
    B.5.5Fax number0
    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 nameHerpes Zoster vaccine GSK1437173A
    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 IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codegE
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Herpes Zoster (HZ) and its related complications
    Herpes Zoster (HZ) e complicazioni cliniche correlate
    E.1.1.1Medical condition in easily understood language
    Herpes zoster (Shingles) disease
    Herpes Zoster (HZ)
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    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 vaccine response rate (VRR) for anti-gE humoral immune responses at Month 2, following a two-dose administration of the HZ/su vaccine, in all subjects.
    - To evaluate the safety and reactogenicity following administration of HZ/su vaccine as compared to placebo from the first vaccination up to 30 days post last vaccination in all subjects.
    - Valutare la percentuale di risposta al vaccino (VRR) per le risposte immunitarie umorali anti-gE al Mese 2, dopo due somministrazioni di vaccino HZ/su, in tutti i soggetti.
    - Valutare la sicurezza e la reattogenicità dopo la somministrazione del vaccino HZ/su, rispetto al placebo, dalla prima vaccinazione fino a 30 giorni dopo l’ultima vaccinazione in tutti i soggetti.
    E.2.2Secondary objectives of the trial
    - To evaluate the anti-gE humoral immune response at Month 2, following a two-dose administration of the HZ/su vaccine, as compared to placebo, in all subjects.
    - To characterise anti-gE humoral immune responses at Months 0, 1, 2, 7 and 13, within the HZ/su and placebo groups, in all subjects.
    - To evaluate VRR for gE-specific CD4+ T-cell mediated immune responses at Month 2, following a two-dose administration of the HZ/su vaccine, in the CMI sub-cohort.
    - To evaluate gE-specific CD4+ T-cell mediated immune (CMI) response at Month 2 following a two-dose administration of the HZ/su vaccine, as compared to placebo, in the CMI sub-cohort.
    - To characterise gE-specific CD4+ T-cell mediated immune responses at Months 0, 2 and 13, within the HZ/su and placebo groups, in the CMI sub-cohort.
    - To evaluate safety following administration of HZ/su vaccine, as compared to placebo, from 30 days post last vaccination until study end in all subjects.
    -Valutare la risposta immunitaria umorale anti-gE al mese 2, dopo due dosi di vaccino HZ/su, rispetto a placebo, in tutti i soggetti.
    - Caratterizzare la risposta immunitaria umorale anti-gE al Mese 0, 1, 2, 7 e 13, nei bracci di trattamento HZ/su e placebo, in tutti i soggetti.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Subjects who, in the opinion of the investigator, can and will comply
    with the requirements of the protocol.
    - A male or female, aged 18 years or older, and having reached the age
    of legal consent, on the date the informed consent is signed. - Written informed consent obtained from the subject.
    - Subject who has received an ABO compatible allogeneic renal
    transplant.
    - Subject receiving maintenance immunosuppressive therapy for the
    prevention of allograft rejection for a minimum of one month (30 days)
    prior to the first vaccination.
    - Subject without an episode of allograft rejection over the previous
    three months (90 days) prior to the first vaccination.
    - Subject with stable renal function. Stability defined as: - less than
    20% variability between last two creatinine measurements or calculated
    glomerular filtration rate [GFR]; - or in the opinion of the investigator
    after investigator review of more than the last two creatinine
    measurements or calculated GFRs.
    - Subject not less than 4 months (120 days) and not more than 18
    months (547 days) after allograft transplantation at the time of the first
    vaccination.
    - Subjects with multiple dialysis options (peritoneal and/or more than
    one anatomical access site for haemodialysis) in the event acute or
    chronic dialysis is needed.
    - Female subjects of non-childbearing potential may be enrolled in the
    study.
    - Female subjects of childbearing potential may be enrolled in the study,
    if the subject:
    *has practiced adequate contraception for 30 days prior to vaccination,
    and
    *has a negative pregnancy test on the day of the first vaccination, and
    *has agreed to continue adequate contraception during the primary
    treatment period and for 2 months after completion of the vaccination
    series.
    1) Pazienti che secondo il giudizio dello Sperimentatore siano in grado di rispettare le richieste del protocollo studio (per esempio: completare le schede diario, ritornare per le visite di follow-up, mantenere contatti regolari con il centro clinico per permettere di essere valutato durante lo studio ed essere contattato telefonicamente). i seguenti criteri di inclusione saranno soddisfatti:
    2) Pazienti, di sesso maschile o femminile, con età ≥ 18 anni al momento della firma del consenso informato.
    3) Consenso informato scritto fornito dal soggetto.
    4) Soggetti che abbiano ricevuto un trapianto allogenico di rene ABO compatibile.
    5) Soggetti che stanno ricevendo una terapia immunosoppressiva di mantenimento per la prevenzione del rigetto di trapianto, da almeno un mese (30 gg) prima della prima dose di vaccino in studio.
    6) Soggetti che non hanno avuto episodi di rigetto di trapianto nei tre mesi (90 gg) che precedono la prima vaccinazione.
    7) Soggetti con funzione renale stabile, definita come:
    − Meno del 20% di variabilità fra le ultime due misurazioni di creatinina o della velocità di filtrazione glomerulare (GFR) calcolata,
    − O definita sulla base dell’opinione dello Sperimentatore, dopo revisione da parte del Medico dello studio di almeno due misurazioni di creatinina o della velocità di filtrazione glomerulare (GFR) calcolata.
    8) Soggetti che abbiano ricevuto un trapianto di rene da non meno di 4 mesi (120 gg) e non più di 18 mesi (547 gg) al momento della prima vaccinazione di studio.
    9) Soggetti con molteplici opzioni dialitiche (accesso peritoneale e/o più di un accesso anatomico per emodialisi) in caso si renda necessaria dialisi acuta o cronica.
    10) 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 della prima vaccinazione e
    − sono d’accordo di continuare l’adeguata contraccezione per l’intero periodo delle vaccinazioni e per 2 mesi dopo il completamento del ciclo vaccinale.
    E.4Principal exclusion criteria
    - Any primary kidney disease with a high incidence of recurrent primary
    kidney disease.
    - Evidence of recurrent primary kidney disease within the current
    allograft.
    - Previous allograft loss secondary to recurrent primary kidney disease.
    * Multiple kidney transplants are allowed if the reason for a previous
    alograft's loss is not recurrent primary kidney disease.
    - More than one organ transplanted (i.e., kidney-liver, double-kidney or
    kidney-other organ(s) transplanted).
    - History of events that, in the opinion of the investigator, may put
    subject at increased risk for chronic allograft dysfunction (e.g., delayed
    graft function, peri-operative complications).
    - Histologic reports of chronic allograft injury (e.g., transplant
    glomerulopathy, arteriopathy, C4d deposition).
    - Evidence of significant proteinuria in the opinion of the investigator.
    - Panel reactive antibody score (PRA or cPRA) that is unknown at the
    time of transplant.
    - Any autoimmune or potential immune-mediated disease, including
    primary kidney disease.
    - Any confirmed or suspected HIV, primary immunodeficiency disease,
    disseminated or untreated malignancy, or systemic infection.
    1) Soggetti con qualsiasi patologia renale primaria con alta incidenza di ricomparsa della patologia stessa. dei seguenti criteri:
    2) Soggetti con evidenza di ricomparsa della patologia primaria renale a livello dell’organo attualmente trapiantato.
    3) Soggetti che hanno perso il precedente trapianto in seguito a ricomparsa di una patologia renale primaria.
    − Sono permessi trapianti renali multipli se la motivazione della perdita del precedente trapianto non è legata alla ricomparsa di una patologia renale primaria.
    4) Soggetti con più di un organo trapiantato (es. rene – fegato; doppio trapianto renale o rene – altro organo).
    5) Soggetti con una storia di eventi che, a giudizio dello Sperimentatore, potrebbero esporre il soggetto ad un aumentato rischio di disfunzionalità cronica d’organo (es. funzionalità ritardata d’organo o complicazioni peri-operatorie).
    6) Evidenze istologiche di danno cronico d’organo (es. glomerulopatia da trapianto, arteriopatia, deposizione di C4d)
    7) Soggetti con evidente proteinuria significativa, a giudizio dello Sperimentatore.
    8) Soggetti per cui non sia noto il valore del PRA (Pannello Anticorpi Reattivi) al momento del trapianto.
    9) Soggetti con qualsiasi patologia autoimmune o potenzialmente immuno-mediata – Tabella 15 del protocollo – inclusa patologia renale primaria, es.
    − sindrome uremica emolitica atipica (microangiopatia trombotica),
    − glomerulosclerosi focale segmentaria (GSFS),
    − glomerulonefrite mesangioproliferativa di tipo I,
    − glomerulonefrite membranoproliferativa di Tipo II (GNMP),
    − malattia da anticorpi anti-membrana basale glomerulare (anti-GBM) Eccezioni all’elenco di patologie escluse (vale a dire quindi patologie permesse
    − nefropatia da IgA, ):
    − glomerulonefrite rapidamente progressiva
    − glomerulonefrite membranosa
    − GNMP idiopatica di tipo I
    − Diabete mellito (tipi 1 e 2) con nefropatia diabetica.
    10) Soggetti con infezione da virus HIV confermata o sospetta, patologia primaria da immunodeficienza, neoplasie disseminate o non trattate o infezione sistemica.
    E.5 End points
    E.5.1Primary end point(s)
    Endpoints Co-Primary:
    - Evaluation of anti-gE humoral immunogenicity, in all subjects, in terms of vaccine response
    - Occurrence of solicited local and general symptoms
    - Occurrence of unsolicited symptoms
    - Occurrence of serious adverse events (SAEs):
    - Occurrence of adverse events of specific interest (AESIs)
    - Evaluation of allograft function
    Endpoints co-primari:
    - Immunogenicità umorale anti-gE, in tutti i soggetti.
    - Comparsa di sintomi attesi, locali e generali
    - Comparsa di sintomi non attesi
    - Comparsa di eventi avversi seri (SAE)
    - Comparsa di AE di specifico interesse (AESI)
    - Funzionalità d’organo
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Anti-gE humoral immunogenicity: Month 2
    - Solicited local and general symptoms: within 7 days (Days 0-6) after
    each vaccination - Unsolicited symptoms: during 30 days (Days 0-29) after each
    vaccination
    - SAEs: from the first vaccination up to 30 days post last vaccination
    - AESIs: from first vaccination up to 30 days post last vaccination
    - Allograft function: from first vaccination up to 30 days post last
    vaccination
    - Immunogenicità umorale anti-gE, in tutti i soggetti: mese 2
    - Comparsa di sintomi attesi, locali e generali: nei 7 giorni successivi ad ogni vaccinazione (Giorni 0-6)
    - Comparsa di sintomi non attesi: nei 30 giorni successivi ad ogni vaccinazione (Giorni 0-29)
    - Comparsa di eventi avversi seri (SAE): dalla prima vaccinazione fino a 30 giorni dopo l’ultima vaccinazione
    - Comparsa di AE di specifico interesse (AESI): dalla prima vaccinazione fino a 30 giorni dopo l’ultima vaccinazione
    - Funzionalità d’organo: dalla prima vaccinazione fino a 30 giorni dopo l’ultima vaccinazione in tutti i soggetti
    E.5.2Secondary end point(s)
    Evaluation of allograft function:
    *Allograft function as measured by serum creatinine.
    Funzionalità d’organo
    o Funzionalità d’organo misurata in base ai valori di creatinina sierica, in tutti i soggetti.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Allograft function: from 30 days post last vaccination until study end
    (Month 13)
    Funzionalità d’organo
    o Funzionalità d’organo misurata in base ai valori di creatinina sierica da 30 giorni dopo l’ultima vaccinazione fino alla fine dello studio, in tutti i soggetti.
    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
    Immunogenicità
    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 Yes
    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
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Canada
    Czech Republic
    Finland
    Italy
    Korea, Democratic People's Republic of
    Panama
    Spain
    Taiwan
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days1
    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: 1
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 180
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 Yes
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 115
    F.4.2.2In the whole clinical trial 250
    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)
    Nessuno
    Nessuno
    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 Decision2015-08-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-06-22
    P. End of Trial
    P.End of Trial StatusCompleted
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu Apr 25 09:58:29 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA