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    Summary
    EudraCT Number:2019-000114-11
    Sponsor's Protocol Code Number:D5290C00004
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-09-04
    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 ConcernedSpain - AEMPS
    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)
    Estudio en fase III aleatorizado, doble ciego, controlado con placebo para evaluar la seguridad y la eficacia de MEDI8897, un anticuerpo monoclonal con una semivida prolongada frente al virus respiratorio sincitial, en bebés sanos nacidos prematuros tardíos y a término (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.
    Estudio clínico para evaluar la seguridad y la eficacia de MEDI8897, un medicamento experimental, para prevenir el virus respiratorio sincitial en bebés sanos nacidos prematuros tardíos y a término.
    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.5.6E-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.3.2Product 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/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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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.
    Prevención de hospitalizaciones VSR confirmado mediante RCP-RT
    E.1.1.1Medical condition in easily understood language
    To prevent serious lower respiratory tract infection caused by RSV.
    Para prevenir una infección grave del tracto respiratorio inferior causada por VSR
    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
    Evaluar la eficacia de MEDI8897, cuando se administra como dosis única por vía i.m. a bebés de EG >= 35 semanas y 0 días que inician su primera temporada del VSR, en la reducción de las IVRB que se han atendido médicamente y que están provocadas por el VSR confirmado mediante RCP-RT, en comparación con 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. Evaluar la eficacia de MEDI8897 en la reducción de las hospitalizaciones a consecuencia del VSR confirmado mediante RCP-RT, en comparación con placebo
    2. Evaluar la seguridad y la tolerabilidad de MEDI8897 cuando se administra como dosis fija única por vía i.m., en comparación con placebo
    3. Evaluar las concentraciones séricas de la dosis única de MEDI8897
    4. Evaluar las respuestas de AAF frente a MEDI8897 en suero
    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
    Los sujetos deben cumplir con todos los siguientes criterios:
    1. Bebés saludables en su primer año de vida y nacidos >= 35 semanas 0 días GA (los bebés que tienen una enfermedad subyacente como fibrosis quística o síndrome de Down sin otros factores de riesgo son elegibles)
    2. Los bebés que están ingresando a su primera temporada de VSR en el momento de la evaluación
    3. Consentimiento informado por escrito y cualquier autorización requerida localmente (p. Ej., La Ley de Responsabilidad y Portabilidad del Seguro de Salud en los EE. UU., La Directiva de Privacidad de Datos de la UE en la UE) obtenida de los padres / representantes legales del sujeto antes de realizar cualquier procedimiento relacionado con el protocolo , incluidas las evaluaciones de detección
    4. El / los padre (s) / representante legal del sujeto puede comprender y cumplir con los requisitos del protocolo, incluidas las visitas de seguimiento y enfermedad según lo juzgue el investigador
    5. El sujeto está disponible para completar el período de seguimiento, que será 17 meses después de recibir el medicamento del estudio.
    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
    Cualquiera de los siguientes excluiría al sujeto de la participación en el estudio:
    1. Cumple con los criterios nacionales u otros locales para recibir palivizumab comercial
    2. Cualquier fiebre (>= 100.4 ° F [>= 38.0 ° C], independientemente de la ruta) o enfermedad aguda dentro de los 7 días anteriores a la randomización.
    3. Cualquier historia de LRTI o LRTI activa antes de, o en el momento de la randomizaciión.
    4. Antecedentes conocidos de infección por VSR o infección activa por VSR antes o en el momento de la randomización.
    5. Cualquier tratamiento farmacológico (crónico u otro) dentro de los 7 días anteriores a la randomización la recepción esperada durante el estudio, con la excepción de: a) multivitaminas y hierro; b) uso infrecuente de medicamentos de venta libre (OTC) para el tratamiento sistémico de los síntomas comunes de la infancia (por ejemplo, analgésicos) que pueden permitirse según el criterio del investigador
    6. Cualquier recibo actual o esperado de agentes inmunosupresores, incluidos los esteroides (a excepción del uso de esteroides tópicos de acuerdo con el criterio del investigador)
    7. Historial de recepción de sangre, hemoderivados o productos de inmunoglobulina, o recepción esperada durante la duración del estudio
    8. Recepción de cualquier mendicamento en investigación.
    9. Insuficiencia renal conocida.
    10. Disfunción hepática conocida, incluida una infección por hepatitis crónica o activa o presunta, conocida o sospechada
    11. Antecedentes de EPC / displasia broncopulmonar
    12. Anomalía congénita clínicamente significativa del tracto respiratorio.
    13. Convulsiones crónicas o trastornos neurológicos inestables o en evolución.
    14. CAP, excepto en niños con CAP no complicada (p. Ej., Conducto arterioso persistente, defecto septal pequeño)
    15. Historia previa de un evento sospechoso o real de amenaza para la vida aguda
    16. Inmunodeficiencia conocida, incluido el virus de inmunodeficiencia humana (VIH)
    17. Madre con infección por VIH (a menos que se haya demostrado que el niño no está infectado)
    18. Cualquier alergia conocida, incluso a productos de inmunoglobulina, o antecedentes de reacción alérgica
    19. Recepción de palivizumab u otro mAb de VSR o cualquier vacuna de VSR , incluida la vacuna materna de VSR
    20. Recepción de cualquier anticuerpo monoclonal o policlonal (por ejemplo, inmunoglobulina de hepatitis B, inmunoglobulina IV)
    21. Cualquier condición que, en opinión del investigador, interfiera con la evaluación del producto en investigación o la interpretación de la seguridad del sujeto o los resultados del estudio.
    22. Matriculación concurrente en otro estudio intervencionista.
    23. Los hijos de los empleados del patrocinador, el sitio del estudio clínico o cualquier otra persona involucrada en la realización del estudio, o los familiares directos de dichas personas
    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)
    Incidencia de las IVRB que se han atendido médicamente (asistencia hospitalaria y ambulatoria) a consecuencia del VSR confirmado mediante RCP-RT durante los 150 días posteriores a la administración de la dosis (es decir, durante una temporada típica del VSR de 5 meses)
    E.5.1.1Timepoint(s) of evaluation of this end point
    150 days after dosing
    150 días despues de la dosis
    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-∞, if data permit
    4. Incidence of ADA to MEDI8897 in serum
    1. Incidencia de las hospitalizaciones a consecuencia del VSR confirmado mediante RT-PCR durante 150 días después de la administración de la dosis (es decir, durante una temporada típica del VSR de 5 meses)
    2. Seguridad y tolerabilidad de MEDI8897, según lo evaluado por la aparición de AAST, AAGST, AAEI y enfermedades crónicas de nueva aparición
    3. Resumen de las concentraciones séricas de MEDI8897 y parámetros FC estimados: aclaramiento aparente y ABC0-∞, si los datos lo permiten.
    4. Incidencia de AAF frente a MEDI8897 en suero
    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).
    Los sujetos serán monitoreados durante todo el estudio para virus respiratorio sincitial.
    La ocurrencia de todos los AAST, AAGST, AAEI y enfermedades cronicas de nueva aparición, se evaluará hasta el Día 361.
    Se recogerá sangre para evaluar la PK de MEDI8897 en suero en la selección y en el Día 15, Día 151, Día 361 y según sea necesario (las muestras de PK se recolectarán para los sujetos hospitalizados con virus respiratorio sincitial).
    La AAF se medirá en la selección y en el Día 151 y el Día 361 y según sea necesario (las muestras de AAF se recogerán para los sujetos hospitalizados 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.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind 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 concerned17
    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 No
    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
    Austria
    Belgium
    Brazil
    Bulgaria
    Canada
    Chile
    Colombia
    Czech Republic
    Estonia
    Finland
    France
    Germany
    Hungary
    Israel
    Italy
    Japan
    Korea, Republic of
    Latvia
    Lithuania
    Mexico
    New Zealand
    Panama
    Poland
    Russian Federation
    South Africa
    Spain
    Sweden
    Turkey
    Ukraine
    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
    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.
    El final del estudio ("finalización del estudio") se define como la fecha de la última visita / evaluación especificada en el protocolo (incluido el contacto telefónico) para el último sujeto del estudio.
    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 days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 3000
    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: 300
    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: 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.3.3.6.1Details of subjects incapable of giving consent
    The study is conducted on late preterm and term infants
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state400
    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)
    None
    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 Decision2019-09-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-08-14
    P. End of Trial
    P.End of Trial StatusOngoing
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