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    EudraCT Number:2016-001677-33
    Sponsor's Protocol Code Number:D5290C00003
    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:2020-11-04
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2016-001677-33
    A.3Full title of the trial
    A Phase 2b Randomised, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Preterm Infants.
    Studio di fase 2b, randomizzato, in doppio cieco, controllato con placebo per valutare la sicurezza e l¿efficacia di MEDI8897, un anticorpo monoclonale a lunga emivita diretto contro il virus respiratorio sinciziale, in neonati pretermine sani
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical Study to Evaluate the Safety and Efficacy of MEDI8897, an Experimental Drug, for Preventing Serious Respiratory Syncytial Virus Disease in Healthy Preterm Infants.
    Studio clinico per valutare la sicurezza e l'efficacia di MEDI8897, un farmaco sperimentale, nel prevenire una malattia respiratoria grave provocata dal virus respiratorio sinciziale in neonati sani pretermine.
    A.3.2Name or abbreviated title of the trial where available
    Clinical Study to Evaluate the Safety and Efficacy of MEDI8897, an Experimental Drug, for Preventing
    Studio clinico per valutare la sicurezza e l'efficacia di MEDI8897, un farmaco sperimentale, per la
    A.4.1Sponsor's protocol code numberD5290C00003
    A.5.4Other Identifiers
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/141/2016
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMEDIMMUNE, LLC
    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 supportMedImmune, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedImmune, LLC
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street AddressOne MedImmune Way
    B.5.3.2Town/ cityGaithersburg, MD
    B.5.3.3Post code20878
    B.5.3.4CountryUnited States
    B.5.4Telephone number00
    B.5.5Fax number00
    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 nameMEDI8897
    D.3.2Product code MEDI8897
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Yes
    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 codeMEDI8897
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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. cell therapy medicinal product Information not present in EudraCT
    D. therapy medical product Information not present in EudraCT
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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) No
    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 placeboSolution 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
    The prevention of medically attending RSV LRTI.
    Prevenzione dell'incidenza di LRTI da RSV
    E.1.1.1Medical condition in easily understood language
    To prevent serious lower respiratory tract infection caused by RSV.
    Prevenire le infezioni gravi del tratto respiratorio inferiore causate da RSV
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10066742
    E.1.2Term Respiratory syncytial virus infection prophylaxis
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of MEDI8897 when administered as a single 50 mg IM dose to healthy preterm infants born between 29 weeks 0 days and 34 weeks 6 days GA and entering their first RSV season for the reduction of medically attended LRTI due to RT-PCR-confirmed RSV, compared to placebo.
    Valutare l¿efficacia di MEDI8897 quando somministrato come singola dose IM da 50 mg a neonati pretermine sani nati tra la 29¿ settimana e 0 giorni e la 34¿ settimana e 6 giorni di EG e che entrano nella loro prima stagione RSV per la riduzione dell¿LRTI nosocomiale causata da RSV confermato mediante RT-PCR, rispetto al placebo
    E.2.2Secondary objectives of the trial
    1. To assess the efficacy of MEDI8897 for the reduction of hospitalisations due to RT-PCR-confirmed
    RSV, compared to placebo.
    2. To evaluate the safety and tolerability of MEDI8897 when administered as a single fixed IM dose,
    compared to placebo.
    3. To evaluate single-dose serum concentrations of MEDI8897.
    4. To evaluate ADA responses to MEDI8897 in serum.
    1. Valutare l¿efficacia di MEDI8897 nel ridurre i ricoveri per RSV confermato mediante RT-PCR, rispetto al placebo
    2. Valutare la sicurezza e la tollerabilit¿ di MEDI8897 quando somministrato come singola dose fissa IM, rispetto al placebo
    3. Valutare le concentrazioni sieriche di MEDI8897 per singola dose
    4. Valutare le risposte ADA a MEDI8897 nel siero
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet all of the following criteria:
    1. Healthy infants born between 29 weeks 0 days and 34 weeks 6 days GA.
    2. Infants who are = 8 months of age and entering their first full RSV season at the time of screening.
    3. Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act [HIPAA] in the USA, European Union [EU] Data Privacy Directive in the EU) obtained from the subject's parent(s)/legal representative prior to performing any protocol-related procedures, including screening evaluations.
    4. Subject's parent(s)/legal representative is able to understand and comply with the requirements of the protocol including follow-up and illness visits as judged by the investigator.
    5. Subject is available to complete the follow-up period, which will be 1 year after receipt of the dose of study drug.
    I soggetti devono soddisfare tutti i seguenti criteri:
    1. Bambini sani nati tra la 29a settimana e 0 giorni e la 34a settimana + 6 giorni di
    Gestazione (GA).
    2. I neonati che hanno = 8 mesi di età e che entrano nella loro prima stagione RSV al momento dello screening.
    3. consenso informato scritto e di qualsiasi autorizzazione richiesta a livello locale (ad esempio,
    Health Insurance Portability e Accountability Act [HIPAA] negli Stati Uniti,
    Unione europea sulla direttiva [UE] I dati nella UE), ottenuto dal/i
    Genitore/i del soggetto / rappresentante legale, prima di eseguire qualsiasi
    procedura relativa al protocollo, comprese le valutazioni di screening.
    4. genitore/i del soggetto (s) / rappresentante legale in grado di comprendere e
    rispettare tutti i requisiti del protocollo compresi il follow-up e le
    visite mediche secondo il giudizio dello sperimentatore.
    5. Il soggetto è a disposizione per completare il periodo di follow-up, che sarà 1
    anno dopo aver ricevuto la dose di farmaco in studio.
    E.4Principal exclusion criteria
    Any of the following would exclude the subject from participation in the study:
    1. Meets AAP or other local criteria to receive commercial palivizumab.
    2. Any fever (= 100.4°F [= 38.0°C], regardless of route) or lower respiratory illness within 7 days prior to randomisation.
    3. Acute illness (defined as the presence of moderate or severe signs and symptoms) at the time of randomisation.
    4. Active RSV infection (a child with signs/symptoms of respiratory infection must have negative RSV testing) or known prior history of RSV infection.
    5. Any drug therapy (chronic or other) within 7 days prior to randomisation or expected receipt during the study with the exception of: 1) multivitamins and iron; 2) infrequent use of over the counter medications for the systemic treatment of common childhood symptoms (eg, pain relievers, decongestants or cough suppressants) that may be permitted according to the judgment of the investigator.
    6. Any current or expected receipt of immunosuppressive agents including steroids (except for the use of topical steroids according to the judgment of the investigator).
    7. History of receipt of blood transfusion or immunoglobulin products or expected receipt through the duration of the study.
    8. Receipt of any investigational drug.
    9. Known renal impairment.
    10. Known hepatic dysfunction including known or suspected active or chronic hepatitis infection.
    11. History of CLD/bronchopulmonary dysplasia.
    12. Clinically significant congenital anomaly of the respiratory tract.
    13. Chronic seizure or evolving or unstable neurologic disorder.
    14. Congenital heart disease, except for children with uncomplicated CHD (eg, patent ductus arteriosus, small septal defect).
    15. Prior history of a suspected or actual acute life-threatening event.
    16. Known immunodeficiency, including human immunodeficiency virus (HIV).
    17. Mother with HIV infection (unless the child has been proven to be not infected).
    18. Any known allergy, including to immunoglobulin products, or history of allergic reaction.
    19. Receipt of palivizumab or other RSV monoclonal antibody or any RSV vaccine, including maternal RSV vaccination.
    20. Receipt of any monoclonal or polyclonal antibody (for example, Hepatitis B immune globulin, intravenous immunoglobulin).
    21. Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.
    22. Concurrent enrollment in another interventional study.
    23. Children of employees of the sponsor, clinical study site, or any other individuals involved with the conduct of the study, or immediate family members of such individuals.
    Note: An individual who initially is excluded from study participation based on one or more of the above time-limited criteria (eg, acute illness) may be reconsidered for enrollment once the condition has resolved as long as the subject continues to meet all other entry criteria.
    Un qualsiasi dei seguenti criteri esclude il soggetto dal partecipare allo studio:
    1. Soddisfa AAP o altri criteri locali per ricevere palivizumab commerciale.
    2. Mostra febbre (= 100,4 ° F [= 38,0 ° C], indipendentemente dal percorso) o presenta malattie del tratto resopiratorio inferiore entro 7 giorni dalla randomizzazione.
    3. malattia acuta (definita come la presenza di segni moderati o gravi e
    sintomi) al momento della randomizzazione.
    4. infezione da RSV attiva (un bambino con segni / sintomi di infezioni respiratorie
    deve avere il test RSV negativo) o nota precedente infezione da RSV.
    5. Qualsiasi terapia farmacologica (cronica o altro) ricevuta o prevista entro 7 giorni prima
    della randomizzazione o durante lo studio con l'eccezione
    di: 1) multivitaminici e ferro; 2) l'uso frequente di farmaci per il trattamento sistemico di sintomi comuni dell’infanzia (Ad esempio, antidolorifici, decongestionanti o sedativi della tosse), che possono essere consentiti secondo il giudizio dello sperimentatore.
    6. Ogni terapia in corso o prevista con agenti immunosoppressivi compresi gli steroidi (eccetto l'uso di steroidi topici secondo il giudizio dello sperimentatore).
    7. Anamnesi di trasfusioni o ricevimento di immunoglobuline e prodotti del sangue
    previsti per tutta la durata dello studio.
    8. ricezione di qualsiasi farmaco sperimentale.
    9. insufficienza renale nota.
    10. disfunzione epatica nota che include sospetta o attiva infezione da epatite cronica.
    11. Storia di CLD / displasia broncopolmonare.
    12. anomalia congenita delle vie respiratorie clinicamente significativa.
    13. Attacco cronico di disturbo neurologico instabile o in evoluzione.
    14. Malattia cardiaca congenita, tranne che per i bambini con complicazioni
    CHD (ad esempio, dotto arterioso pervio, piccolo difetto del setto).
    15. storia precedente di un evento di pericolo di vita acuto o sospetto.
    16. immunodeficienza nota, tra cui virus dell'immunodeficienza umana
    17. La madre con infezione da HIV (a meno che il bambino è stato dimostrato di essere
    non infetto).
    18. Qualsiasi allergia nota, anche per i prodotti di immunoglobuline, o la storia
    di reazione allergica.
    19.Somministrazione nota di palivizumab o altro anticorpo monoclonale RSV o qualsiasi vaccino contro RSV, compresa la vaccinazione RSV materna.
    20. Somministrazione di qualsiasi anticorpo monoclonale o policlonale (ad esempio,
    Epatite B immunoglobuline, immunoglobuline per via endovenosa).
    21. Qualsiasi condizione che, a giudizio dello sperimentatore, interferirebbe
    con la valutazione del prodotto in sperimentazione o l'interpretazione dei dati
    di sicurezza o dei risultati dello studio.
    22. contemporanea partecipazione ad un altro studio interventistico.
    23. figli dei dipendenti dello sponsor, sito studio clinico, o qualsiasi altra
    persona coinvolta nella conduzione dello studio, o i membri immediati della famiglia di tale individuo.
    Nota: Un soggetto che inizialmente viene escluso dalla partecipazione allo studio
    sulla base di uno o più dei criteri di cui sopra (ad esempio, malattia acuta) può essere riconsiderato a partecipare allo studio una volta che la condizione che ha decretato l’esclusione sia stata
    risolta e che il soggetto soddisfi tutti gli altri criteri di inclusione.
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of medically attended LRTI (inpatient and outpatient) due to
    RT-PCR-confirmed RSV over the duration of the 5-month RSV season.
    Incidenza di LRTI medicalmente assistito (pazienti ricoverati e ambulatoriali) causato da RSV e confermato mediante RT_PCR per tutta la durata della stagione RSV 5 mesi.
    E.5.1.1Timepoint(s) of evaluation of this end point
    5-month RSV season
    durata di 5 mesi della stagione RSV
    E.5.2Secondary end point(s)
    1. Incidence of hospitalisations due to RT-PCR-confirmed RSV over the
    duration of the 5-month RSV season.
    2. Safety and tolerability of MEDI8897 as assessed by the occurrence of
    all treatment-emergent adverse events (TEAEs), treatment-emergent
    serious adverse events (TESAEs), adverse events of special interest
    (AESIs), and new onset chronic diseases (NOCDs).
    3. Single-dose MEDI8897 serum concentrations.
    4. Incidence of ADA to MEDI8897 in serum.
    1. Incidenza di ricoveri per RSV confermato mediante RT-PCR per la durata dei 5 mesi della stagione RSV
    2. Sicurezza e tollerabilit¿ di MEDI8897 valutate in base all¿insorgenza di tutti gli eventi avversi emergenti dal trattamento (TEAE), gli eventi avversi gravi emergenti dal trattamento (TESAE), gli eventi avversi di particolare interesse (AESI) e delle malattie croniche di nuova insorgenza (NOCD)
    3. Concentrazioni sieriche di MEDI8897 per singola dose
    4. Incidenza di ADA diretti contro MEDI8897 nel siero
    E.5.2.1Timepoint(s) of evaluation of this end point
    Subjects will be monitored throughout the study for LRTI.
    Occurrence of all treatment-emergent adverse events (TEAEs),
    treatment-emergent serious adverse events (TESAEs), adverse events of
    special interest (AESIs), and new onset chronic diseases (NOCDs), will
    be assessed throughout the study.
    Blood will be collected to evaluate the PK of MEDI8897 in serum at
    screening and on Day 91, Day 151, Day 361 and as needed (PK samples
    will be collected for subjects hospitalised with LRTI).
    To determine the duration of MEDI8897 serum levels post dosing and to
    correlate with the development of ADA, serum concentrations will be
    measured at 360 days post dosing. ADA will be measured at Day 91,
    Day151 and Day 361 and as needed (ADA samples will be collected for
    subjects hospitalised with LRTI).
    I soggetti saranno monitorati durante lo studio per LRTI.
    Presenza di tutti gli eventi avversi emergenti dal trattamento (TEAEs),
    gravi eventi avversi emergenti (TESAEs), eventi avversi di
    particolare interesse (Aesis), e insorgenza di nuove malattie croniche (NOCDs), saranno
    valutati nel corso dello studio.
    Il sangue sar¿ raccolto per valutare la PK di MEDI8897 nel siero allo
    screening e nei giorni 91, 151, 361 e, se necessario (campioni PK
    saranno raccolti per i soggetti ospedalizzati con LRTI).
    Per determinare la durata dei livelli sierici di MEDI8897 inviare dosaggio e
    correlare con lo sviluppo della ADA, concentrazioni sieriche saranno
    misurate 360 giorni dopo la somministrazione. ADA sar¿ misurato ai giorni 91, 151 e 361 e, se necessario (campioni ADA saranno raccolti per
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    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. trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    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 EEA101
    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
    New Zealand
    Russian Federation
    South Africa
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    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 Yes
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F. of subjects for this age range: 1500
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F. of subjects for this age range: 1500
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F. of subjects incapable of giving consent
    The study is conducted on preterm infants <= 8 months of age.
    Lo studio viene condotto su neonati pretermine di et¿ <=8 mesi
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 779
    F.4.2.2In the whole clinical trial 1500
    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)
    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 Decision2016-10-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-22
    P. End of Trial
    P.End of Trial StatusCompleted
    The status of studies in GB is no longer updated from 1.1.2021
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