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    Summary
    EudraCT Number:2021-005319-30
    Sponsor's Protocol Code Number:217917
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-09-06
    Trial 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 number2021-005319-30
    A.3Full title of the trial
    A phase 3b, open-label, multi-country, multi-centre, long-term follow-up study of ZOSTER-049 (follow-up of ZOSTER-006/022 studies) to assess the prophylactic efficacy, safety and persistence of immune response of a Herpes Zoster subunit vaccine and assessment of persistence of immune response and safety of 1 or 2 additional doses administered in ZOSTER-049 in 2 subgroups of older adults
    Studio di fase 3b, in aperto, multinazionale, multicentrico, di follow-up a lungo termine di ZOSTER-049 (follow-up degli studi ZOSTER-006/022) per valutare l’efficacia profilattica, la sicurezza e la persistenza della risposta immunitaria di un vaccino a subunità anti-Herpes Zoster e per la valutazione della persistenza della risposta immunitaria e della sicurezza di 1 o 2 dosi aggiuntive somministrate in ZOSTER-049 a 2 sottogruppi di persone anziane.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study on the long-term efficacy, safety and persistence of immune response of a vaccine against Herpes Zoster in older adults
    Studio sull’efficacia, sulla sicurezza e sulla persistenza a lungo termine della risposta immunitaria di un vaccino anti-Herpes Zoster nelle persone anziane.
    A.3.2Name or abbreviated title of the trial where available
    ZOSTER-101
    ZOSTER-101
    A.4.1Sponsor's protocol code number217917
    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 number442089904466
    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 Yes
    D.2.1.1.1Trade name SHINGRIX
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline Biologicals SA EU/1/18/1272/001-1 Vial and 1 vial; EU/1/18/1272/002-10 vials and 10
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameNA
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Powder and suspension 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.3.9.4EV Substance CodeSUB31416
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Vaccination against HZ and its related complications in adults older than 50 years (at the time of primary vaccination).
    Vaccinazione contro HZ e relative complicanze negli adulti di età superiore a 50 anni (al momento della vaccinazione primaria).
    E.1.1.1Medical condition in easily understood language
    Herpes zoster (Shingles) disease.
    Malattia da herpes zoster (fuoco di Sant’Antonio).
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10036376
    E.1.2Term Post herpetic neuralgia
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10030865
    E.1.2Term Ophthalmic herpes zoster
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10063491
    E.1.2Term Herpes zoster oticus
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10075611
    E.1.2Term Varicella zoster virus infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10074297
    E.1.2Term Herpes zoster cutaneous disseminated
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level PT
    E.1.2Classification code 10080516
    E.1.2Term Herpes zoster reactivation
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level PT
    E.1.2Classification code 10084396
    E.1.2Term Disseminated varicella zoster virus infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10072210
    E.1.2Term Genital herpes zoster
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10061208
    E.1.2Term Herpes zoster infection neurological
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10074259
    E.1.2Term Herpes zoster meningitis
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10074248
    E.1.2Term Herpes zoster meningoencephalitis
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10074243
    E.1.2Term Varicella zoster oesophagitis
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10074254
    E.1.2Term Varicella zoster pneumonia
    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 the vaccine efficacy (VE) of HZ/su in preventing HZ.
    Valutare l’efficacia del vaccino (vaccine efficacy, [VE]) di HZ/su nella prevenzione di HZ.
    E.2.2Secondary objectives of the trial
    • To evaluate the VE of HZ/su in preventing HZ from 1-month post Dose 2 in the ZOSTER-006/022 studies until the end of the ZOSTER-101 study.
    • To evaluate persistence of the humoral immune response to HZ/su.
    • To evaluate persistence of the cell-mediated immune response to HZ/su.
    • To evaluate vaccine safety of HZ/su.
    • Valutare la VE di HZ/su nella prevenzione di HZ da 1 mese post dose 2 negli studi ZOSTER-006/022 fino alla fine dello studio ZOSTER-101.
    • Valutare la persistenza della risposta immunitaria umorale a HZ/su.
    • Valutare la persistenza della risposta immunitaria cellulo-mediata a HZ/su.
    • Valutare la sicurezza del vaccino a HZ/su.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Participants and participant’s caregiver, who, in the opinion of the investigator, can and are willing to comply with the requirements of the protocol.
    • Written or witnessed/thumb printed informed consent obtained from the participant of the participant prior to performance of any study-specific procedure.
    • Medically stable participants as established by medical history and clinical examination before entering into the study.
    • Participants who completed ZOSTER-049 study (following at least 1 dose of HZ/su in ZOSTER-006/022 studies).
    • Partecipanti e caregiver dei partecipanti, che, a giudizio dello sperimentatore, sono in grado di e sono disposti a rispettare i requisiti del protocollo.
    • Consenso informato scritto o con testimone/impronta del pollice del partecipante ottenuto dal partecipante prima dell’esecuzione di qualsiasi procedura specifica dello studio.
    • Partecipanti clinicamente stabili, come stabilito dall’anamnesi medica e dall’esame clinico prima dell’ingresso nello studio.
    • Partecipanti che hanno completato lo studio ZOSTER-049 (dopo almeno 1 dose di HZ/su nell’ambito degli studi ZOSTER-006/022).
    E.4Principal exclusion criteria
    Medical conditions
    • Any clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.

    Prior/Concomitant therapy
    • Use of any investigational or non-registered product (drug, vaccine or medical device) for the treatment of HZ or Varicella Zoster Virus (VZV) infection at the time of enrolment or their planned use during the study period.
    • Previous vaccination against VZV or HZ and/or planned administration during the study of a VZV or HZ vaccine (including an investigational or non-registered vaccine other than HZ/su administered in studies ZOSTER-006/022 or ZOSTER-049).

    Prior/Concurrent clinical study experience
    • Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug/invasive medical device) for the prevention and/or treatment of HZ or VZV and which may have a possible activity against VZV.
    Condizioni mediche
    • Qualsiasi condizione clinica che, a giudizio dello sperimentatore, potrebbe comportare un rischio aggiuntivo per il partecipante a causa della partecipazione allo studio.

    Terapia pregressa/concomitante
    • Uso di qualsiasi prodotto sperimentale o non registrato (farmaco, vaccino o dispositivo medico) per il trattamento dell’infezione da HZ o virus Varicella Zoster (Varicella Zoster Virus, [VZV]) al momento dell’arruolamento o il loro uso programmato durante il periodo dello studio.
    • Precedente vaccinazione contro VZV o HZ e/o somministrazione programmata durante lo studio di un vaccino anti-VZV o HZ (incluso un vaccino sperimentale o non registrato diverso da HZ/su somministrato negli studi ZOSTER-006/022 o ZOSTER-049).

    Esperienza in studi clinici precedenti/concomitanti
    • Partecipazione concomitante a un altro studio clinico, in qualsiasi momento durante il periodo dello studio, in cui il partecipante è stato o sarà esposto a un trattamento sperimentale o non sperimentale (farmaco/dispositivo medico invasivo) per la prevenzione e/o il trattamento di HZ o VZV e che potrebbe avere una possibile attività contro VZV.
    E.5 End points
    E.5.1Primary end point(s)
    Number of participants in LTFU and Control groups with confirmed HZ cases
    Numero di partecipanti nei gruppi LTFU e di controllo con casi confermati di HZ
    E.5.1.1Timepoint(s) of evaluation of this end point
    During the total duration of ZOSTER-101 study (Day 1 through Month 48)
    Nell’arco della durata totale dello studio ZOSTER-101 (dal Giorno 1 al Mese 48)
    E.5.2Secondary end point(s)
    1. Number of participants in LTFU and Control groups with confirmed HZ cases
    2. Anti-glycoprotein E (gE) antibody concentrations
    3. Frequency of gE-specific Cluster of Differentiation (CD)4+ T-cells secreting at least two activation markers from among IFN-¿, IL-2, TNF-a, CD40L
    4. Percentage of participants with serious adverse events (SAEs) causally related to the study intervention
    5. Percentage of participants with potential immune-mediated diseases (pIMDs) (serious and non-serious) causally related to the study intervention
    6. Percentage of participants with HZ-related complications of confirmed HZ
    1. Numero di partecipanti nei gruppi LTFU e di controllo con casi confermati di HZ
    2. Concentrazioni degli anticorpi anti-glicoproteina E (gE)
    3. Frequenza di cellule T del cluster di differenziazione (CD)4+ gE-specifiche che secernono almeno due marcatori di attivazione tra IFN-¿, IL-2, TNF-a, CD40L
    4. Percentuale di partecipanti che manifestano eventi avversi seri (Serious adverse events, [SAE]) causalmente correlati al trattamento dello studio
    5. Percentuale di partecipanti con potenziali malattie immuno-mediate (potential immune-mediated diseases, [pIMD]) (gravi e non gravi) causalmente correlate al trattamento dello studio
    6. Percentuale di partecipanti che manifestano complicanze correlate a HZ di HZ confermato
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. From 1-month post-Dose 2 in the ZOSTER-006/022 studies until the end of the ZOSTER-101 study at Month 48
    2, 3. At Day 1, Months 12, 24, 36 and 48 in the ZOSTER-101 study
    4, 5, 6. During the total duration of the ZOSTER-101 study (Day 1 through Month 48)
    1. Da 1 mese post-dose 2 negli studi ZOSTER-006/022 fino alla fine dello studio ZOSTER-101 al Mese 48
    2, 3. Al Giorno 1, Mesi 12, 24, 36 e 48 nello studio ZOSTER-101 4, 5, 6. Nell’arco della durata totale dello studio ZOSTER-101 (dal Giorno 1 fino al Mese 48)
    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
    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 No
    E.8.1.2Open Yes
    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
    Fattoriale
    Factorial
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Efficacia del vaccino-Controllo storico; Immunogenicità, sicurezza per gruppi randomizzati-nessun in
    Vaccine efficacy-Historical Control; Immunogenicity, safety for randomized groups-no intervention
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA68
    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
    Australia
    Brazil
    Canada
    Hong Kong
    Japan
    Korea, Republic of
    Mexico
    Taiwan
    United States
    Estonia
    Finland
    France
    Sweden
    Spain
    Czechia
    Germany
    Italy
    United Kingdom
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LSLV (Visit 5) or Date of the last testing/reading released of the Human Biological Samples or imaging data, related to primary and secondary endpoints, whichever comes later. EoS must be achieved no later than 8 months after LSLV.
    Ultima visita dell’ultimo soggetto (Last Subject Last Visit, [LSLV]) (Visita 5) o Data dell’ultimo test/lettura rilasciato dei dati di diagnostica per immagini o dei campioni biologici umani, correlati agli endpoint primari e secondari, a seconda di quale evento si verifichi più tardi. La fine dello studio (End of study, [EoS]) deve essere raggiunta non più tardi di 8 mesi dopo la LSLV.
    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 months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days8
    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: 1356
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2306
    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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state17
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2519
    F.4.2.2In the whole clinical trial 3662
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Not applicable
    Non pertinente
    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 Decision2022-09-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-14
    P. End of Trial
    P.End of Trial StatusOngoing
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