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    The EU Clinical Trials Register currently displays   39833   clinical trials with a EudraCT protocol, of which   6536   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2016-001677-33
    Sponsor's Protocol Code Number:D5290C00003
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-07-15
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    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.
    Estudio de fase IIb 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 prematuros sanos.
    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.
    Estudio clínico para evaluar la seguridad y eficacia de MEDI8897 , un fármaco experimental, para prevenir la enfermedad respiratoria grave por virus sincitial respiratorio en niños prematuros sanos.
    A.4.1Sponsor's protocol code numberD5290C00003
    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 number0034981955373
    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.3.8INN - Proposed INNnot available
    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 No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 attending RSV LRTI.
    Prevención de las infecciones de las vías respiratorias bajas (IVRB) que se han atendido médicamente y que están provocadas por el virus sincitial respiratorio (VSR).
    E.1.1.1Medical condition in easily understood language
    To prevent serious lower respiratory tract infection caused by RSV.
    Prevención de las infecciones de las vías respiratorias bajas (IVRB) causadas 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 19.0
    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.
    Evaluar la eficacia de MEDI8897 cuando se administra como dosis única de 50 mg por vía i.m. a bebés prematuros sanos nacidos entre 29 semanas 0 días y 34 semanas 6 días de EG y que inician su primera temporada del VSR para la reducción de las IVRB que se han atendido médicamente y que están provocadas por el VSR confirmado mediante la RCP-RT en tiempo real, en comparación con 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. Evaluar la eficacia de MEDI8897 para la reducción de hospitalizaciones a consecuencia del VSR confirmado mediante la 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 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.
    Los sujetos deben cumplir todos los criterios siguientes:
    1. Lactantes sanos nacidos entre 29 semanas 0 días y 34 semanas 6 días de EG.
    2. Lactantes que tengan ≤8 meses de edad y que empiecen su primera temporada completa del VRS en el momento de la selección.
    3. Consentimiento informado por escrito y cualquier autorización requerida a nivel local (por ejemplo, Ley de Transferibilidad y Responsabilidad del Seguro Médico [HIPAA] en los EE. UU., Directiva sobre privacidad de los datos en la Unión Europea [UE]) obtenidos del progenitor o progenitores/representante legal del sujeto antes de realizar cualquier procedimiento relacionado con el protocolo, que incluyen las evaluaciones de selección.
    4. El progenitor o progenitores/representante legal del sujeto pueden comprender y cumplir los requisitos del protocolo, incluido el seguimiento y las visitas a la consulta médica a criterio del investigador.
    5. El sujeto está disponible para completar el periodo de seguimiento, que será de 1 año tras haber recibido la dosis del fármaco del estudio.
    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.
    Cualquiera de los criterios siguientes excluirá al sujeto de la participación en el estudio:
    1. Cumple los criterios de la Academia Estadounidense de Pediatría (AAP) u otros criterios locales para recibir palivizumab comercializado.
    2. Fiebre (≥100,4 °F [≥38,0 °C], independientemente de la vía) o enfermedad de las vías respiratorias inferiores en los 7 días previos a la aleatorización.
    3. Enfermedad aguda (definida como la presencia de signos y síntomas moderados o graves) en el momento de la aleatorización.
    4. Infección por VRS activa (un niño con signos o síntomas de infección respiratoria debe dar negativo en las pruebas del VRS) o antecedentes previos conocidos de infección por VRS.
    5. Cualquier tratamiento farmacológico (crónico u otro) en los 7 días previos a la aleatorización o previsión de que se reciba durante el estudio a excepción de: 1) multivitaminas y hierro; 2) uso poco frecuente de medicamentos de venta sin receta para el tratamiento sistémico de síntomas habituales en la infancia (p. ej., analgésicos, descongestionantes o antitusígenos) que pueden permitirse según el criterio del investigador
    6. Cualquier recepción actual o prevista de inmunodepresores, incluidos los corticoesteroides (excepto el uso de corticoesteroides tópicos según el criterio del investigador).
    7. Antecedentes de recepción de transfusión de sangre o productos de inmunoglobulina o previsión de que se reciban durante el estudio.
    8. Recepción de cualquier fármaco en investigación.
    9. Disfunción renal conocida.
    10. Disfunción hepática conocida, incluida la infección conocida o sospechada de hepatitis crónica o activa.
    11. Antecedentes de EHC/displasia broncopulmonar.
    12. Anomalía congénita de las vías respiratorias clínicamente significativa.
    13. Trastorno convulsivo crónico o trastorno neurológico inestable o en evolución.
    14. Cardiopatía congénita, excepto niños con CC sin complicaciones (p. ej., conducto arterial persistente, pequeño defecto del tabique).
    15. Antecedentes de un acontecimiento potencialmente mortal agudo real o sospecha de este.
    16. Inmunodeficiencia conocida, incluido el virus de la 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, incluidos los productos de inmunoglobulina, o antecedentes de reacciones alérgicas.
    19. Recepción de palivizumab u otro anticuerpo monoclonal contra el VRS o cualquier vacuna contra el VRS, incluida la vacunación materna contra el VRS.
    20. Recepción de cualquier anticuerpo monoclonal o policlonal (por ejemplo, inmunoglobulina de la hepatitis B, inmunoglobulina intravenosa).
    21. Cualquier condición que, en opinión del investigador, pueda interferir en la evaluación del producto en investigación o la interpretación de la seguridad del sujeto o de los resultados del estudio.
    22. Inscripción simultánea en otro estudio intervencionista.
    23. Hijos de empleados del promotor, del centro del estudio clínico o de cualquier otra persona implicada en la realización del estudio o familiares directos de esas personas.

    Nota: Una persona que inicialmente se excluya de la participación en el estudio por uno o varios de los criterios anteriores de tiempo limitado (p. ej., enfermedad aguda) puede reconsiderarse para la inscripción, una vez que la condición se haya resuelto y siempre y cuando el sujeto continúe cumpliendo todos los demás criterios de inclusión.
    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.
    Incidencia de hospitalizaciones por infecciones de las vías respiratorias bajas (IVRB)atribuibles al VSR confirmado mediante la reacción en cadena de la polimerasa retrotranscriptasa (RCP-RT) en tiempo real durante los 5 meses de la temporada del VSR.
    E.5.1.1Timepoint(s) of evaluation of this end point
    5-month RSV season
    5 meses de la temporada del VSR.
    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. Incidencia de las hospitalizaciones a consecuencia del VSR confirmado mediante la RCP-RT durante la temporada de 5 meses del VSR.
    2. Seguridad y tolerabilidad de MEDI8897, según lo evaluado por todos los casos de acontecimientos adversos surgidos durante el tratamiento (AAST), acontecimientos adversos graves surgidos durante el tratamiento (AAGST), acontecimientos adversos de especial interés (AAEI) y enfermedades crónicas de nueva aparición.
    3. Concentraciones séricas de la dosis única de MEDI8897.
    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 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).
    Los sujetos serán monitorizados en cuanto a las IVRB durante todo el estudio.
    Incidencia de todos los AAST, AAGST, AAEI y enfermedades crónicas de nueva aparición durante todo el estudio.
    Evaluación de la farmacocinética (FC) de MEDI8897 en suero en la visita de selección, día 91, 151, 361 y cuando sea necesario (muestras para FC serán recogidas en los sujetos hospitalizados por IVRB).
    Determinar la duración de los niveles séricos de MEDI8897 después de la dosificación y evaluar la ocrrelación del desarrollo de anticuerpos antifármaco (AAF). concentraciones séricas serán medidas el día 360 después de la dosificación.
    AAF serán medidas los días 91, 151, 361 y cuando sea necesario (muestras AAF serán recogidas en los sujetos hospitalizados por IVRB).
    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 concerned5
    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 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
    Czech Republic
    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 years1
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    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.1.1Number of subjects for this age range: 1500
    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.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state58
    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 Decision2016-09-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-12-06
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