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    Summary
    EudraCT Number:2017-003859-36
    Sponsor's Protocol Code Number:VAC18194RSV2002
    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:2019-04-12
    Trial 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 number2017-003859-36
    A.3Full title of the trial
    A Randomized, Controlled, Observer-blind, Phase 1/2a Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Ad26.RSV.preF in RSV-seronegative Toddlers 12 to 24 Months of Age
    Ensayo en fase 1/2a, aleatorizado, con observador ciego, controlado, para evaluar la seguridad, reactogenicidad e inmunogenicidad de Ad26.RSV.preF en niños seronegativos para Virus Respiratorio Sincitial de 12 a 24 meses de edad.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Ad26.RSV.preF in respiratory syncytial virus (RSV)-seronegative Toddlers
    Ensayo para evaluar la seguridad, reactogenicidad e inmunogenicidad de Ad26.RSV.preF en niños seronegativos para Virus Respiratorio Sincitial.
    A.4.1Sponsor's protocol code numberVAC18194RSV2002
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/318/2018
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJanssen Vaccines and Prevention B.V.
    B.1.3.4CountryNetherlands
    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 supportJanssen Vaccines and Prevention B.V.
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag S.A.
    B.5.2Functional name of contact pointGlobal Clinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de las Doce Estrellas 5-7
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28042
    B.5.3.4CountrySpain
    B.5.4Telephone number0034917228637
    B.5.5Fax number0034917228628
    B.5.6E-maillmarti89@its.jnj.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 nameAd26.RSV.preF
    D.3.2Product code JNJ-64400141
    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 INNAd26.RSV.preF
    D.3.9.2Current sponsor codeJNJ-64400141
    D.3.9.3Other descriptive nameJNJ-64400141
    D.3.9.4EV Substance CodeSUB187098
    D.3.10 Strength
    D.3.10.1Concentration unit billion organisms/ml billion organisms/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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) Yes
    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 Yes
    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 Nimenrix
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Europe MA EEIG
    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 nameNimenrix
    D.3.4Pharmaceutical form Powder and solvent for solution for injection in pre-filled syringe
    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 INNNeisseria meningitidis serogroup A polysaccharide conjugated to tetanus toxoid
    D.3.9.3Other descriptive nameNEISSERIA MENINGITIDIS GROUP A POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
    D.3.9.4EV Substance CodeSUB36479
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNeisseria meningitidis group C polysaccharide conjugated to tetanus toxoid carrier protein
    D.3.9.3Other descriptive nameNEISSERIA MENINGITIDIS SEROGROUP C POLYSACCHARIDE (PSC) CONJUGATED TO TETANUS TOXOID (TT)
    D.3.9.4EV Substance CodeSUB31471
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNeisseria meningitidis serogroup W-135 polysaccharide conjugated to tetanus toxoid
    D.3.9.3Other descriptive nameNEISSERIA MENINGITIDIS GROUP W-135 POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
    D.3.9.4EV Substance CodeSUB36481
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNeisseria meningitidis serogroup Y polysaccharide conjugated to tetanus toxoid
    D.3.9.3Other descriptive nameNEISSERIA MENINGITIDIS GROUP Y POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
    D.3.9.4EV Substance CodeSUB36482
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    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
    Prophylactic respiratory syncytial virus (RSV)
    Virus respiratorio sincitial profiláctico (VRS)
    E.1.1.1Medical condition in easily understood language
    Preventive against RSV
    Preventivo contra VRS
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10061603
    E.1.2Term Respiratory syncytial virus infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to assess the safety and reactogenicity of an intramuscular regimen of 3 doses of 2.5×10e10 viral particles (vp) of Ad26.RSV.preF in RSV-seronegative toddlers aged 12 to 24 months.
    Evaluar la seguridad y la reactogenicidad de la pauta de tratamiento consistente en 3 dosis de 2,5 × 10e10 partículas víricas (pv) de Ad26.RSV.preF por vía intramuscular en niños seronegativos para el VRS de entre 12 y 24 meses de edad.
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    • To assess the humoral and cellular immune responses elicited by Ad26.RSV.preF as measured by virus neutralizing antibodies (VNAs), F protein binding antibodies (pre-F and/or post-F), and T-helper (Th)1/Th2 subtyping.
    • To monitor for severe RSV-lower respiratory tract infection (LRTI) as a preliminary indication of enhanced respiratory disease (ERD).
    Los objetivos secundarios son.
    • Evaluar la respuesta inmune humoral y celular provocada por Ad26.RSV.preF a partir de las medidas de anticuerpos neutralizadores de virus (ANV), anticuerpos con unión específica a la proteína F (pre-F y/o post-F) y subtipos (Th)1/Th2 de los linfocitos T cooperadores.
    • Supervisar la aparición de infecciones graves de las vías respiratorias inferiores (IVRI) provocadas por el VRS como indicación preliminar de enfermedad respiratoria potenciada (ERP).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Each potential subject must satisfy all of the following criteria to be enrolled in the study:
    1. Each subject’s parent(s)/legal guardian(s) must sign an informed consent form (ICF) indicating that he/she understands the purpose of and procedures required for the study, are willing for his/her child to participate in the study and attend all scheduled visits, and are willing and able to comply with all study procedures, including maintaining contact with the site for 2 RSV seasons following the first dose, and adhere to the prohibitions and restrictions specified in this protocol.
    Note: For each subject, at least one parent or legal guardian, according to local regulations, must give written consent.
    2. Subject is male or female, whose age on the day of ICF signature is ≥12 months to ≤24 months and who is seronegative for RSV within 42 days prior to dosing.
    Note: Serostatus may be assessed via the RSV enzyme immunoassay (EIA) if available from a different study. If done within 42 days of first dose, this assessment would not have to be repeated in the absence of a history of respiratory infection during that period.
    3. Subject is the product of a normal term pregnancy ≥37 weeks, with a minimum birth weight of 2.5 kilogram (kg).
    4. Subject must be in good health without any significant medical illness on the basis of physical examination, medical history, and vital signs performed at screening.
    5. Subject has received all routine immunizations appropriate for his or her age according to local guidelines.
    6. Each subject’s parent(s)/legal guardian(s) must have access to a consistent means of contact either by telephone contact or email/computer.
    Cada potencial sujeto debe cumplir con todos los siguientes criterios para ser seleccionado en el estudio:
    1. Los padres/tutores legales de cada sujeto deben firmar un formulario de consentimiento informado (ICF) que indique que él/ella entiende el propósito y los procedimientos requeridos para el estudio, están dispuestos a que su hijo/a participe, asista a todas las visitas programadas, y esté dispuesto y sea capaz de cumplir con todos los procedimientos del estudio, incluido mantener el contacto con el centro durante 2 temporadas de VRS después de la primera dosis, y cumplir con las prohibiciones y restricciones especificadas en este protocolo.
    Nota: Para cada sujeto, al menos un padre o tutor legal, de acuerdo con las regulaciones locales, debe dar su consentimiento por escrito.
    2. El sujeto es hombre o mujer, cuya edad en el día de la firma del ICF es ≥12 meses a ≤24 meses y que es seronegativo para RSV dentro de los 42 días anteriores a la dosificación.
    Nota: El estado serológico se puede evaluar a través del inmunoensayo enzimático RSV (EIA) si está disponible en un estudio diferente. Si se realiza dentro de los 42 días de la primera dosis, esta evaluación no debería repetirse en ausencia de antecedentes de infección respiratoria durante ese período.
    3. El sujeto es el producto de un embarazo a término normal ≥37 semanas, con un peso al nacer mínimo de 2.5 kilogramos (kg).
    4. El sujeto debe estar en buen estado de salud sin ninguna enfermedad médica significativa basada en un examen físico, historial médico y signos vitales realizados en la selección.
    5. El sujeto ha recibido todas las inmunizaciones de rutina apropiadas para su edad de acuerdo con las pautas locales.
    6. El padre (s) / tutor (es) legal (es) de cada sujeto debe tener acceso a un medio de contacto consistente, ya sea telefónico o correo electrónico.
    E.4Principal exclusion criteria
    Any potential subject who meets any of the following criteria will be excluded from participating in the study:
    1. Subject has moderate or severe illness (this does not include minor illnesses such as diarrhea) or temperature ≥38.0 ºC within 24 hours prior to the first dose of study vaccine; enrollment at a later date is permitted.
    2. Any subject who has had an respiratory tract infection (RTI) between screening and randomization that the principal investigator(s) [PI(s)] feels would make them ineligible.
    3. Subject’s weight is below 10th percentile according to World Health Organization (WHO) pediatric growth and weight charts.
    4. Subject has any clinically significant acute or chronic medical condition (eg, history of seizure disorders, bleeding/clotting disorder, autoimmune disease, active malignancy, systemic infections, congenital heart disease, history of any pulmonary condition requiring medication, atopy, reactive airway disease, medically-confirmed wheezing, bronchoconstriction or treatment with a β2 agonist, cystic fibrosis, bronchopulmonary dysplasia, chronic pulmonary disease, medically-confirmed apnea, hospitalization for respiratory illness, or mechanical ventilation for respiratory illness) that, in the opinion of the investigator, would preclude participation.
    5. Subject has major congenital anomalies (after discussion with the study responsible physician/ scientist [SRP/S]) or known cytogenetic disorders (eg, Down’s syndrome).
    6. Subject has had major surgery within the 4 weeks prior to randomization or has planned major surgery through the course of the study.
    7. Subject is in receipt of, or planning to receive, live attenuated vaccine (eg, measles, mumps and rubella [MMR] or varicella, but excluding rotavirus vaccine) within 28 days of each study vaccination (ie, before and after); other vaccines (eg, influenza, pertussis, polio or rotavirus) should be given at least 14 days before or 14 days after each study vaccination.
    Note: Planning for routine childhood vaccinations will be available from the site to ensure that these can be taken at appropriate times during the study.
    8. Subject has known or suspected immunodeficiency, such as known human immunodeficiency virus (HIV) infection.
    9. Subject has received an investigational drug or used an invasive investigational medical device within 30 days or received an investigational vaccine within 6 months before the planned administration of the first dose of study vaccine or is currently enrolled or plans to participate in another investigational study during this study.
    Note: Participation in an observational clinical study (ie, with no intervention) is allowed upon approval of the sponsor.
    10. Subject has a known allergy to vaccines or vaccine components (including any of the constituents of the study vaccine), or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine components (including any of the constituents of the study vaccine). Note: subjects with egg allergies can be enrolled.
    11. Subject has a history of the following moderate to severe chronic conditions: urticaria (recurrent hives), eczema and/or atopic dermatitis.
    12. Subject has a history of acute polyneuropathy (eg, Guillain-Barré syndrome).
    13. Subject has chronic or recurrent use of immunomodulators/suppressors, eg, cancer chemotherapeutic agents, oral or parenteral corticosteroids for at least 5 days within 42 days prior to randomization, or planned during the study.
    14. Subject has a history of receipt of blood products or immunoglobulin within 3 months of randomization.
    15. Subject has been in receipt of palivizumab/Synagis® or received any other vaccine or monoclonal/polyclonal antibody in a previous RSV study at any time prior to randomization.
    16. Subject has a contraindication to intramuscular injections and blood draws, eg, bleeding disorders.
    17. Subject has a history of an underlying clinically significant acute or chronic medical condition or physical examination findings for which, in the opinion of the investigator, participation would not be in the best interest of the subject (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
    18. Subject’s parent(s)/legal guardian(s) cannot communicate reliably with the investigator.
    19. Subject is a family member of either the investigator, study-site employee, or employee of the sponsor.
    Cualquier potencial sujeto que cumpla alguno de los siguientes criterios será excluido de participar:
    1. El sujeto tiene una enfermedad moderada o grave (no enfermedades menores como diarrea) o temperatura ≥38.0 ºC dentro de las 24 horas previas a la primera dosis del estudio de la vacuna; Se permite la inscripción en una fecha posterior.
    2. Cualquier sujeto que haya tenido una infección del tracto respiratorio (RTI) entre la selección y la aleatorización que el investigador, (es) principal (es) considere (n) que no serán elegibles.
    3. Peso del sujeto por debajo del percentil 10 de acuerdo con las tablas de crecimiento y peso pediátrico de la Organización Mundial de la Salud (OMS).
    4. El sujeto tiene una condición médica aguda o crónica clínicamente significativa (p.e: antecedentes de convulsiones, hemorragia/coagulación, enfermedad autoinmune, enfermedad maligna activa, infecciones sistémicas, cardiopatía congénita, antecedentes de cualquier condición pulmonar que requiera medicación, atopia, enfermedad reactiva de las vías respiratorias, sibilancias confirmadas médicamente, broncoconstricción o tratamiento con agonistas β2, fibrosis quística, displasia broncopulmonar, enfermedad pulmonar crónica, apnea confirmada médicamente, hospitalización por enfermedad respiratoria o ventilación mecánica para la enfermedad respiratoria) que, en opinión del investigador , impediría la participación.
    5. El sujeto tiene anomalías congénitas importantes (después de discusión con el médico/científico responsable del estudio [SRP / S]) o trastornos citogenéticos conocidos (por ejemplo, síndrome de Down).
    6. El sujeto se sometió a una cirugía mayor dentro de las 4 semanas previas a la aleatorización o si se planificó una cirugía mayor a lo largo del estudio.
    7. Vacuna dirigida atenuada (por ejemplo, sarampión, paperas y rubéola [MMR] o varicela, pero excluyendo la vacuna contra el rotavirus) dentro de los 28 días posteriores a cada vacunación (es decir, antes y después); Se deben administrar otras vacunas (por ejemplo, influenza, tosferina, polio o rotavirus) al menos 14 días antes o 14 días después de cada vacunación.
    Nota: La planificación para las vacunas de rutina para niños estará disponible en el sitio para garantizar que se puedan tomar en los momentos adecuados durante el estudio.
    8. El sujeto tiene inmunodeficiencia conocida o sospechada, como una infección conocida por el virus de la inmunodeficiencia humana (VIH).
    9. El sujeto ha recibido un medicamento en investigación o usado un dispositivo médico de investigación invasivo dentro de los 30 días o recibido una vacuna en investigación dentro de los 6 meses anteriores a la administración planificada de la primera dosis de la vacuna del estudio o está actualmente inscrito o planea participar en otra investigación.
    Nota: La participación en un estudio clínico observacional (es decir, sin intervención) se permite con la aprobación del sponsor.
    10. El sujeto es alérgico a las vacunas o componentes de la vacuna, o historial de anafilaxis u otras reacciones adversas graves a las vacunas o componentes de la vacuna (incluido cualquiera de los componentes del estudio de la vacuna). Nota: los sujetos con alergia al huevo pueden ser inscritos.
    11. El sujeto tiene antecedentes de las siguientes afecciones crónicas de moderadas a graves: urticaria (urticaria recurrente), eccema y/o dermatitis atópica.
    12. El sujeto tiene antecedentes de polineuropatía aguda (p.e: Síndrome de Guillain-Barré).
    13. Sujeto al uso crónico o recurrente de inmunomoduladores supresores, por ejemplo, agentes quimioterapéuticos para el cáncer, corticosteroides orales o parenterales durante al menos 5 días dentro de los 42 días anteriores a la aleatorización, o planificados durante el estudio.
    14. El sujeto tiene un historial de recepción de hemoderivados o inmunoglobulina dentro de los 3 meses posteriores a la aleatorización.
    15. El sujeto haya recibido palivizumab/Synagis® o cualquier otra vacuna o anticuerpo monoclonal/policlonal en un estudio previo de RSV en cualquier momento antes de la aleatorización.
    16. El sujeto tiene una contraindicación para las inyecciones intramusculares y la extracción de sangre, p.e:, trastornos hemorrágicos.
    17. El sujeto tiene un historial de una condición médica aguda o crónica subyacente clínicamente significativa o hallazgos de examen físico para los cuales, en opinión del investigador, la participación no sería en el mejor interés del sujeto (p.e: comprometer el bienestar) o que podría prevenir, limitar o confundir las evaluaciones especificadas en el protocolo.
    18. Los padres/tutores legales del sujeto no pueden comunicarse de manera confiable con el investigador.
    19. El sujeto es un miembro de la familia del investigador, de un empleado del centro de estudio o del sponsor.
    E.5 End points
    E.5.1Primary end point(s)
    1. Solicited local and systemic adverse events (AEs)
    2. Unsolicited AEs
    3. Serious adverse events (SAEs)
    1. Acontecimientos adversos locales y sistémicos solicitados (AAs).
    2. AAs no solicitados
    3. Acontecimientos adversos graves (AAGs).
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. For 7 days after each vaccination
    2. For 28 days after each vaccination
    3. From first dose administration to the end of the study
    1. 7 días después de cada vacunación.
    2. 28 días después de cada vacunación.
    3. Desde la administración de la primera dosis hasta el final del estudio
    E.5.2Secondary end point(s)
    1. Humoral Immune Response - RSV neutralization A strain
    2. Humoral Immune Response - F protein antibodies (enzyme-linked immunosorbent assay [ELISA]; pre- and/or post-F)
    3. Cell-mediated Immune Response - Flow cytometry (intracellular cytokine staining [ICS]) - Analysis of T-cell responses to RSV F protein peptides for Th1/Th2 subtyping
    4. RSV Infection - Severe RSV-LRTI
    1. Respuesta inmune humoral: neutralización de la cepa A del VRS.
    2. Respuesta inmune humoral: anticuerpos frente a la proteína F (ensayo inmunoabsorbente ligado a enzimas [ELISA]; pre- y / o post-F)
    3. Respuesta inmunitaria mediada por células: citometría de flujo (tinción de citocina intracelular [ICS]) - Análisis de las respuestas de las células T a los péptidos de la proteína F del VRS para el subtipo Th1 / Th2
    4. Infección por RSV - RSV-IVRI grave.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 and 2. Either at screening or prior to vaccination on Day 1, Day 8, Day 85, end of first RSV season and/or early exit
    3. Either at screening or prior to vaccination on Day 1, Day 85 and/or early exit
    4. From first dose to the end of the study
    1 y 2. Ya sea en la selección o antes de la vacunación en el Día 1, Día 8, Día 85, final de la primera temporada de VRS y / o salida anticipada
    3. Ya sea en la selección o antes de la vacunación en el Día 1, Día 85 y / o discontinuación del estudio.
    4. Desde la primera dosis hasta el final del estudio.
    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 No
    E.6.6Pharmacokinetic No
    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 Yes
    E.6.13.1Other scope of the trial description
    Reactogenicity and Immunogenicity
    Reactogenicidad e inmunogenicidad.
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Safety, Reactogenicity, and Immunogenicity study
    Seguridad, reactogenicidad e inmunogenicidad.
    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) Yes
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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
    Australia
    Brazil
    Canada
    Finland
    Germany
    Poland
    Spain
    Sweden
    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 will be the last subject’s last visit (by telephone) at the end of the safety follow-up phase through 2 RSV seasons after the first dose.
    El final del estudio será la última visita del sujeto (por teléfono) al final de la fase de seguimiento de seguridad a través de 2 temporadas de VRS después de la primera dosis.
    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 months3
    E.8.9.1In the Member State concerned days27
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days27
    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: 48
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 48
    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
    Paediatric patients aged between ≥12 months to ≤24 months
    Pacientes pediátricos con edades comprendidas entre ≥12 meses y ≤24 meses
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 33
    F.4.2.2In the whole clinical trial 48
    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
    Ninguno.
    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 Decision2019-05-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-01
    P. End of Trial
    P.End of Trial StatusOngoing
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