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    EudraCT Number:2019-000114-11
    Sponsor's Protocol Code Number:D5290C00004
    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:2021-05-24
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2019-000114-11
    A.3Full title of the trial
    A Phase 3 Randomized, 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 Late Preterm and Term Infants (MELODY)
    Studio di Fase 3, 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 tardivi e a termine sani (MELODY)
    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 Late Preterm and Term Infants.
    Studio clinico per valutare la sicurezza e l'efficacia di MEDI8897, un farmaco sperimentale, per prevenire la malattia del virus sinciziale respiratorio grave in lattanti prematuri e terminali sani.
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberD5290C00004
    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.5.4Telephone number0000000
    B.5.5Fax number000000
    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 namend
    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.3.8INN - 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 milligram(s)
    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 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
    Per 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 assess the efficacy of MEDI8897 when administered as a single fixed
    IM dose to infants = 35 weeks 0 days GA and entering their first RSV
    season, in reducing medically attended LRTI due to RT-PCR-confirmed
    RSV, compared to placebo
    Valutare l’efficacia di MEDI8897 quando somministrato come singola dose fissa IM a neonati di EG = 35 settimane e 0 giorni che entrano nella loro prima stagione RSV nel ridurre l’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 in reducing hospitalizations 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 tollerabilità 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 in their first year of life and born = 35 weeks 0 days GA (infants who have an underlying illness such as cystic fibrosis or Down syndrome with no other risk factors are eligible)
    2. Infants who are entering their first RSV season at the time of screening
    3. 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 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 17 months after receipt of study drug
    I soggetti devono soddisfare tutti i seguenti criteri:
    1. Neonati sani nel loro primo anno di vita e nati = 35 settimane 0 giorni di EG (sono idonei lattanti che hanno una malattia sottostante come fibrosi cistica o sindrome di Down con o senza altri fattori di rischio)
    2. I neonati che entrano nella loro prima stagione di RSV al momento dello screening
    3. Consenso informato scritto e qualsiasi autorizzazione richiesta a livello locale (ad es., Health Insurance Portability and Accountability Act negli Stati Uniti, Direttiva UE sulla protezione dei dati nell’UE) ottenuti dal/i genitore/i o dal rappresentante legale del soggetto prima di eseguire qualsiasi procedura correlata al protocollo, incluse le valutazioni di screening
    4. Il/I genitore/i o il rappresentante legale del soggetto è/sono in grado di comprendere e adempiere ai requisiti del protocollo, incluse le visite di follow-up e malattia secondo il giudizio dello sperimentatore
    5. Il soggetto è disponibile a completare il periodo di follow-up, che sarà 17 mesi dopo la ricezione del farmaco dello studio
    E.4Principal exclusion criteria
    Any of the following would exclude the subject from participation in the study:
    1. Meets national or other local criteria to receive commercial palivizumab
    2. Any fever (= 100.4°F [= 38.0°C], regardless of route) or acute illness within 7 days prior to randomization
    3. Any history of LRTI or active LRTI prior to, or at the time of, randomization
    4. Known history of RSV infection or active RSV infection prior to, or at the time of, randomization
    5. Any drug therapy (chronic or other) within 7 days prior to randomization or expected receipt during the study with the exception of: a) multivitamins and iron; b) infrequent use of over-the-counter (OTC) medications for the systemic treatment of common childhood symptoms (eg, pain relievers) 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, blood products, 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. CHD, 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 mAb or any RSV vaccine, including maternal RSV vaccination
    20. Receipt of any monoclonal or polyclonal antibody (for example, hepatitis B immune globulin, IV 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
    Uno qualsiasi dei seguenti criteri escluderebbe il soggetto dalla partecipazione allo studio:
    1 Soddisfa i criteri nazionali o altri criteri locali per ricevere palivizumab commerciale
    2 Qualsiasi febbre (= 38,0°C, indipendentemente dalla via) o malattia acuta entro 7 giorni prima della randomizzazione
    3 Qualsiasi anamnesi di LRTI o LRTI attiva prima o al momento della randomizzazione
    4 Anamnesi nota di infezione da RSV o infezione da RSV attiva prima o al momento della randomizzazione
    5 Qualsiasi terapia farmaceutica (cronica o altro) entro 7 giorni prima della randomizzazione o della prevista ricezione durante lo studio, ad eccezione di: a) multivitaminici e ferro; b) uso di farmaci da banco non frequente per il trattamento sistemico di sintomi comuni dell’infanzia (come antidolorifici) che possono essere consentiti a discrezione dello sperimentatore
    6 Qualsiasi attuale o prevista prescrizione di agenti immunosoppressivi, inclusi steroidi (fatta eccezione per l’uso di steroidi topici a discrezione dello sperimentatore)
    7 Anamnesi di ricezione di sangue, prodotti ematici o prodotti a base di immunoglobulina, oppure ricezione prevista per la durata dello studio
    8 Ricezione di qualsiasi farmaco sperimentale
    9 Nota insufficienza renale
    10 Nota disfunzione epatica, inclusa nota o sospetta infezione epatica attiva o cronica
    11 Anamnesi di malattia polmonare cronica (CLD)/ displasia broncopolmonare
    12 Anomalia congenita del tratto respiratorio clinicamente significativa
    13 Crisi convulsiva cronica o disturbo neurologico instabile o in evoluzione
    14 Malattia coronarica cronica (CHD), fatta eccezione per i bambini con CHD non complicata (ad es., dotto arterioso pervio, piccolo difetto del setto)
    15 Precedente anamnesi di un evento acuto, potenzialmente letale sospetto o effettivo
    16 Immunodeficienza nota, inclusa infezione da virus dell’immunodeficienza umana (HIV)
    17 Madre con infezione da HIV (a meno che non sia dimostrato che il bambino risulti non infetto)
    18 Qualsiasi allergia nota, inclusi i prodotti a base di immunoglobulina, o anamnesi di reazione allergica
    19 Prescrizione di palivizumab o altro anticorpo monoclonale (mAb) per RSV o di qualsiasi vaccino anti-RSV, inclusa la vaccinazione anti-RSV materna
    20 Ricezione di qualsiasi anticorpo policlonale o monoclonale (per esempio, immunoglobuline per l’epatite B, immunoglobuline per via endovenosa)
    21 Qualsiasi condizione che, secondo lo sperimentatore, interferirebbe con la valutazione del prodotto sperimentale o l’interpretazione della sicurezza del soggetto o dei risultati studio
    22 Arruolamento concomitante in un altro studio interventistico
    23 Bambini di dipendenti dello sponsor, del centro in cui si svolge lo studio clinico o eventuali altri individui coinvolti nella conduzione dello studio, o parenti stretti di tali individui
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of medically attended LRTI (inpatient and outpatient) due to RT-PCR-confirmed RSV through 150 days after dosing (ie, during a typical 5-month RSV season)
    Incidenza di LRTI nosocomiale (pazienti ospedalizzati e ambulatoriali) da RSV confermato mediante RT-PCR fino a 150 giorni dopo la somministrazione (ovvero, durante una tipica stagione RSV di 5 mesi)
    E.5.1.1Timepoint(s) of evaluation of this end point
    150 days after dosing
    150 giorni dopo la somministrazione
    E.5.2Secondary end point(s)
    1. Incidence of hospitalizations due to RT-PCR-confirmed RSV through 150 days after dosing (ie, during a typical 5-month RSV season)
    2. Safety and tolerability of MEDI8897 as assessed by the occurrence of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), adverse events of special interest (AESIs), and new onset chronic diseases (NOCDs)
    3. Summary of MEDI8897 serum concentrations and estimated PK parameters: apparent clearance, AUC0-8, if data permit
    4. Incidence of ADA to MEDI8897 in serum
    1. Incidenza dei ricoveri per RSV confermato mediante RT-PCR fino a 150 giorni dopo la somministrazione (ovvero, durante una tipica stagione RSV di 5 mesi)
    2. Sicurezza e tollerabilità di MEDI8897 valutate in base all’insorgenza di eventi avversi emergenti dal trattamento (TEAE), eventi avversi gravi emergenti dal trattamento (TESAE), eventi avversi di particolare interesse (AESI) e malattie croniche di nuova insorgenza (NOCD)
    3. Riassunto delle concentrazioni sieriche di MEDI8897 e dei parametri PK stimati: clearance apparente, AUC0-8, se i dati lo consentono
    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 TEAEs, TESAEs, AESIs, and NOCDs, will be assessed through Day 361.
    Blood will be collected to evaluate the PK of MEDI8897 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).
    ADA will be measured at screening and at 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.
    L'evento di tutti i TEAE, TESAE, AESI e NOCD sarà valutato durante il giorno 361.
    Il sangue verrà prelevato per valutare il PK di MEDI8897 nel siero allo screening e nel giorno 15, giorno 151, giorno 361 e, se necessario (campioni PK saranno raccolti per soggetti ospedalizzati con LRTI).
    L'ADA sarà misurata allo screening e al Day151 e al Day 361 e secondo necessità (i campioni ADA saranno raccolti per soggetti ospedalizzati con LRTI).
    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. trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA158
    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
    Korea, Republic of
    New Zealand
    Russian Federation
    South Africa
    United States
    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 in studio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    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 months6
    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: 300
    F.1.1.3Newborns (0-27 days) Yes
    F. of subjects for this age range: 50
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F. of subjects for this age range: 2950
    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 late preterm and term infants
    Lo studio è condotto su neonati pretermine tardivi e a termine sani
    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 1461
    F.4.2.2In the whole clinical trial 3000
    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 Decision2019-07-26
    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 StatusOngoing
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