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    Summary
    EudraCT Number:2019-000201-69
    Sponsor's Protocol Code Number:D5290C00005
    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:2021-01-22
    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 number2019-000201-69
    A.3Full title of the trial
    A Phase 2/3 Randomized, Double-blind, Palivizumab-controlled Study to Evaluate the Safety of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in High-risk Children (MEDLEY)
    Studio di fase 2/3 randomizzato, in doppio cieco, controllato con palivizumab per valutare la sicurezza di MEDI8897, un anticorpo monoclonale a lunga emivita diretto contro il virus respiratorio sinciziale, in bambini ad alto rischio (MEDLEY)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical Study to Evaluate the Safety of MEDI8897, an Experimental Drug, for Preventing Serious Respiratory Syncytial Virus Disease in High-risk Children.
    Studio clinico per valutare la sicurezza di MEDI8897, un farmaco sperimentale, per prevenire la malattia del virus sinciziale respiratorio grave in bambini ad alto rischio.
    A.3.2Name or abbreviated title of the trial where available
    na
    na
    A.4.1Sponsor's protocol code numberD5290C00005
    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.1.3.4CountryUnited States
    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.5.6E-mailinformation.center@astrazeneca.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 namena
    D.3.2Product code [MEDI8897]
    D.3.4Pharmaceutical form Solution 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.3.8INN - Proposed INNnirsevimab
    D.3.9.1CAS number 1989556-22-0
    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.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) 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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Synagis
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie Deutschland GmbH Co. KG
    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 nameSynagis
    D.3.2Product code [Palivizumab]
    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.3.8INN - Proposed INNPALIVIZUMAB
    D.3.9.1CAS number 188039-54-5
    D.3.9.2Current sponsor codeNA
    D.3.9.4EV Substance CodeSUB03606MIG
    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.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) 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 attended RSV LRTI.
    La prevenzione dell'RSV LRTI medicalmente frequentato.
    E.1.1.1Medical condition in easily understood language
    To prevent serious lower respiratory tract infection caused by RSV.
    Prevenire gravi infezioni 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 evaluate the safety and tolerability of MEDI8897 compared to palivizumab when administered to high-risk infants eligible to receive palivizumab entering their first RSV season and children with chronic lung disease (CLD) or congenital heart disease (CHD) entering their first and second RSV season.
    Valutare la sicurezza e la tollerabilità di MEDI8897 rispetto a palivizumab quando somministrato a neonati pretermine che entrano nella loro prima stagione RSV e bambini con CLD o CHD che entrano nella loro prima e seconda stagione RSV
    E.2.2Secondary objectives of the trial
    1. To evaluate serum concentrations of MEDI8897 and palivizumab
    2. To evaluate ADA responses to MEDI8897 and to palivizumab in serum
    3. To assess the descriptive efficacy of MEDI8897 when administered as a single IM dose in the first RSV season or a single IM dose administered in the second RSV season, in reducing medically attended LRTI (inpatient and outpatient) and hospitalization due to RT-PCR-confirmed RSV, compared to palivizumab
    1. Valutare le concentrazioni sieriche di MEDI8897 e palivizumab
    2. Valutare le risposte ADA a MEDI8897 e a palivizumab nel siero
    3. Valutare l’efficacia descrittiva di MEDI8897 quando somministrato come singola dose IM di 50 mg a neonati di peso <5 kg o 100 mg a neonati di peso =5 kg nella loro prima stagione RSV o una singola dose IM da 200 mg somministrata nella seconda stagione RSV, nel ridurre l’LRTI nosocomiale (pazienti ricoverati e ambulatoriali) e il ricovero a seguito di infezione da RSV confermata mediante RT-PCR, rispetto a palivizumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet all of the following criteria:
    1. For the preterm cohort (excluding subjects with CLD or hemodynamically significant CHD): preterm infants in their first year of life and born = 35 weeks 0 days GA eligible to receive palivizumab in accordance with national or local guidelines, including those with:
    (a) Uncomplicated small atrial or ventricular septal defects or patent ductus arteriosus, or
    (b) Aortic stenosis, pulmonic stenosis, or coarctation of the aorta alone
    2. For the CLD/CHD cohort:
    (a) Subjects with CLD - infants in their first year of life and a diagnosis of CLD of prematurity requiring medical intervention/management (ie, supplemental oxygen, bronchodilators, or diuretics) within the 6 months prior to randomization
    (b) Subjects with CHD - infants in their first year of life and documented, hemodynamically significant CHD (must be unoperated or partially corrected CHD) Note: Infants with hemodynamically significant acyanotic cardiac lesions must have pulmonary hypertension (= 40 mmHg measured pressure in the pulmonary artery) or the need for daily medication to manage CHD
    3. Infants who are entering their first RSV season at the time of screening
    4. Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act in the USA, EU Data Privacy Directive in the EU) obtained from the subject's parent(s)/legal representative(s) prior to performing any protocol-related procedures, including screening evaluations
    5. Subject's parent(s)/legal representative(s) able to understand and comply with the requirements of the protocol including follow-up and illness visits as judged by the investigator
    6. Subject is available to complete the follow-up period, which will be 1 year after Season 1/ Dose 1 for subjects without CLD/CHD, or 1 year after Season 2/Dose 1 (or last replacement dose as applicable for CHD) for subjects with CLD/CHD
    I soggetti devono soddisfare tutti i seguenti criteri:
    1 Per la coorte pretermine (escludendo i soggetti con CLD o CHD emodinamicamente significativa): i neonati pretermine nel loro primo anno di vita e nati a un’età gestazionale =35 settimane e 0 giorni sono idonei ad assumere palivizumab secondo le linee guida nazionali o locali, inclusi quelli con:
    (a) Lievi difetti non complicati del setto atriale o ventricolare o del dotto arterioso pervio, oppure
    (b) Stenosi aortica, stenosi polmonare o sola coartazione aortica
    2 Per la coorte CLD/CHD:
    (a) Soggetti con CLD: neonati nel loro primo anno di vita e con diagnosi di CLD dovuta a nascita prematura, che richiedono intervento/gestione medica (vale a dire integrazione di ossigeno, broncodilatatori o diuretici) nei 6 mesi precedenti la randomizzazione
    (b) Soggetti con CHD: neonati nel loro primo anno di vita e con CHD emodinamicamente significativa documentata (la CHD non deve essere stata operata né parzialmente corretta)
    Nota: i neonati con lesioni cardiache acianotiche emodinamicamente significative devono presentare ipertensione polmonare (=40 mmHg di pressione misurata nell’arteria polmonare) o la necessità di farmaci quotidiani per gestire la CHD
    3 Neonati che entrano nella loro prima stagione RSV al momento dello screening
    4 Consenso informato scritto e qualsiasi autorizzazione eventualmente richiesta a livello locale (per esempio l’Health Insurance Portability and Accountability Act negli USA, la Direttiva UE per la privacy dei dati nell’Unione Europea) ottenuti dai genitori/rappresentanti legali del soggetto prima dell’esecuzione di qualsiasi procedura correlata al protocollo, incluse le valutazioni di screening
    5 I genitori/rappresentanti legali del soggetto sono in grado di comprendere e di rispettare tutto ciò che è previsto dal protocollo, incluse le visite di follow-up e in caso di malattia, secondo il giudizio dello sperimentatore
    6 Il soggetto è disponibile per completare il periodo di follow-up, che avrà durata di 1 anno dopo la Stagione 1/Dose 1 per i soggetti senza CLD/CHD oppure di 1 anno dopo la Stagione 2/Dose 1 (o l’ultima dose sostitutiva, secondo quanto applicabile per la CHD) per i soggetti con CLD/CHD
    E.4Principal exclusion criteria
    Any of the following would exclude the subject from participation in the study:
    1. Any fever (= 100.4°F [= 38.0°C], regardless of route) or acute illness within 7 days prior to randomization
    2. Any history of LRTI or active LRTI prior to, or at the time of, randomization
    3. Known history of RSV infection or active RSV infection prior to, or at the time of, randomization
    4. Hospitalization at the time of randomization, unless discharge is expected within the 7 days after randomization
    5. Requirement for mechanical ventilation, extracorporeal membrane oxygenation, CPAP, or other mechanical respiratory or cardiac support at the time of randomization
    6. Anticipated cardiac surgery within 2 weeks after randomization
    7. Anticipated survival of < 6 months after randomization
    8. Receipt of any investigational drug
    9. Known renal impairment
    10. Known hepatic dysfunction including known or suspected active or chronic hepatitis infection
    11. Clinically significant congenital anomaly of the respiratory tract
    12. Chronic seizure, or evolving or unstable neurologic disorder
    13. Prior history of a suspected or actual acute life-threatening event
    14. Known immunodeficiency, including human immunodeficiency virus (HIV)
    15. Mother with HIV infection (unless the child has been proven to be not infected)
    16. Any known allergy, including to immunoglobulin products, or history of allergic reaction
    17. Receipt of palivizumab or other RSV mAb or any RSV vaccine, including maternal RSV vaccination
    18. Receipt of any monoclonal or polyclonal antibody (for example, hepatitis B immune globulin, intravenous immunoglobulin) or anticipated use during the study
    19. Any condition that, in the opinion of the investigator, would interfere with evaluation of the study drug or interpretation of subject safety or study results
    20. Concurrent enrollment in another interventional study
    21. 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
    1 Presenza di febbre (=38,0 °C, indipendentemente dalla modalità di misurazione) o malattia in fase acuta nei 7 giorni precedenti la randomizzazione
    2 Anamnesi di LRTI o LRTI in fase attiva prima della randomizzaizone o al momento della randomizzazione
    3 Anamnesi nota di infezione da RSV o infezione da RSV in fase attiva prima della randomizzazione o al momento della randomizzazione
    4 Ospedalizzazione al momento della randomizzazione, a meno che la dimissione non sia prevista nei 7 giorni precedenti la randomizzazione
    5 Necessità di ventilazione meccanica, ossigenazione extracorporea a membrana, ventilazione meccanica a pressione positiva continua (Continuous Positive Airway Pressure, CPAP) o altro supporto meccanico di tipo respiratorio o cardiaco al momento della randomizzazione
    6 Intervento chirurgico al cuore previsto nelle 2 settimane successive alla randomizzazione
    7 Sopravvivenza prevista <6 mesi dopo la randomizzazione
    8 Assunzione di qualsiasi farmaco sperimentale
    9 Nota compromissione a livello renale
    10 Nota disfunzione epatica, inclusa un’infezione attiva o cronica da epatite accertata o sospetta
    11 Anomalia congenita clinicamente significativa delle vie respiratorie
    12 Disturbo convulsivo cronico o disturbo neurologico instabile o in evoluzione
    13 Anamnesi di evento acuto potenzialmente letale sospetto o accertato
    14 Nota immunodeficienza, incluso il virus dell’immunodeficienza umano (HIV)
    15 Madre con infezione da HIV (a meno che sia stato dimostrato che il bambino non è infetto)
    16 Qualsiasi allergia nota, inclusa quella ai prodotti a base di immunoglobuline, o anamnesi di reazione allergica
    17 Assunzione di palivizumab o di un altro anticorpo monoclonale o di un vaccino contro l’RSV, inclusa la vaccinazione materna contro l’RSV
    18 Assunzione di qualsiasi anticorpo monoclonale o policlonale (per esempio immunoglobulina per l’epatite B, immunoglobulina per via endovenosa) o loro uso previsto durante lo studio
    19 Qualsiasi condizione che, secondo il parere dello sperimentatore, interferirebbe con la valutazione del farmaco dello studio o con l’interpretazione dei risultati di sicurezza del soggetto o dei risultati dello studio
    20 Arruolamento concomitante in un altro studio interventistico
    21 Figli di dipendenti dello sponsor, del centro sede dello studio clinico, di qualsiasi altro individuo coinvolto nello svolgimento dello studio o di parenti stretti di tali individui
    E.5 End points
    E.5.1Primary end point(s)
    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).
    Sicurezza e tollerabilità di MEDI8897 valutate in base all’insorgenza di tutti i TEAE, TESAE, AESI e NOCD
    E.5.1.1Timepoint(s) of evaluation of this end point
    Occurrence of all TEAEs, TESAEs, AESIs, and NOCDs, will be assessed through the follow-up period (Day 361).
    Il verificarsi di tutti i TEAE, TESAE, AESI e NOCD sarà valutato durante il periodo di follow-up (giorno 361).
    E.5.2Secondary end point(s)
    1. a. MEDI8897 and palivizumab serum concentrations
    b. MEDI8897 and palivizumab PK parameters: Summary of serum concentrations and estimated PK parameters (Cmax, AUC, apparent clearance, and t1/2, if data permit)
    2. Incidence of ADA to MEDI8897 and palivizumab in serum
    3. a. Incidence of medically attended LRTI (inpatient and outpatient) due to RT-PCR-confirmed RSV through 150 days after Dose 1 for Season 1 and Season 2
    b. Incidence of hospitalizations due to RT-PCR-confirmed RSV through 150 days after Dose 1 for Season 1 and Season 2
    1. a. Concentrazioni sieriche di MEDI8897 e palivizumab
    b. Parametri PK di MEDI8897 e palivizumab: Riassunto delle concentrazioni sieriche e dei parametri PK stimati (Cmax, AUC, clearance apparente e t1/2, se i dati lo consentono)
    2. Incidenza di ADA diretti contro MEDI8897 e palivizumab nel siero
    3. a. Incidenza di LRTI nosocomiale (pazienti ricoverati e ambulatoriali) da RSV confermato mediante RT-PCR fino a 150 giorni dopo la Dose 1 per la Stagione 1 e la Stagione 2
    b. Incidenza di ricoveri per infezioni da RSV confermato mediante RT PCR fino a 150 giorni dopo la Dose 1 per la Stagione 1 e la Stagione 2
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Blood will be collected to evaluate the PK of MEDI8897 and palivizumab in serum at screening and on Day 15, Day 151, Day 361 and as needed (PK samples will be collected for subjects hospitalised with LRTI) for season 1 and season 2 (CLD/CHD Cohort Only). Subjects requiring a replacement dose of study drug due to cardiac surgery with cardiopulmonary bypass will have a blood sample collected before and after surgery (prior to administering replacement dose) for PK evaluation.
    2. ADA will be measured at screening and on Day 151 and Day 361 and as needed (ADA samples will be collected for subjects hospitalised with LRTI).
    3. Incidence of LRTI and hospitalizations due to RSV will be monitored through Day 151 post dose in Season 1 and Season 2.
    1. Il sangue verrà raccolto per valutare il PK di MEDI8897 e palivizumab nel siero allo screening e al giorno 15, 151, 361 e, se necessario (campioni PK saranno raccolti per sogg ricoverati con LRTI) per la stagione 1 e 2 (Solo coorte CLD/CHD). I sogg che richiedono una dose sostitutiva del farmaco a causa di un intervento cardiochirurgico con bypass cardiopolmonare avranno un campione di sangue raccolto prima e dopo l'intervento chirurgico (prima della sommi di una dose sostitutiva) per la valutazione PK.
    2. L'ADA sarà misurata allo screening e al giorno 151 e 361 e secondo necessità (i campioni ADA saranno raccolti per i soggetti ricoverati con LRTI).
    3. L'incidenza di LRTI e le ospedalizzazioni dovute a RSV saranno monitorate durante il Day 151 dopo la dose nella Stagione 1 e nella 2.
    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 No
    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.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    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 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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    palivizumab
    palivizumab
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA117
    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
    Argentina
    Australia
    Brazil
    Canada
    Chile
    Colombia
    Israel
    Japan
    Korea, Republic of
    Mexico
    New Zealand
    Panama
    Russian Federation
    South Africa
    Turkey
    Ukraine
    United States
    Austria
    Belgium
    Bulgaria
    Czechia
    Estonia
    Finland
    France
    Germany
    Hungary
    Italy
    Latvia
    Lithuania
    Poland
    Spain
    Sweden
    United Kingdom
    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
    The end of the study (“study completion”) is defined as the date of the last protocol-specified visit/assessment (including telephone contact) for the last subject in the study.
    La fine dello studio ("completamento dello studio") è definita come la data dell'ultima visita / valutazione specificata dal protocollo (incluso il contatto telefonico) per l'ultimo soggetto dello studio.
    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 months0
    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 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 Yes
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F.1.1.2.1Number of subjects for this age range: 1000
    F.1.1.3Newborns (0-27 days) Yes
    F.1.1.3.1Number of subjects for this age range: 50
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 1450
    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.3.3.6.1Details of subjects incapable of giving consent
    The study is conducted in infants in their first year of life.
    Lo studio è condotto nei bambini nel loro primo anno di vita.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 890
    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)
    None
    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 Decision2019-09-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-11
    P. End of Trial
    P.End of Trial StatusCompleted
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