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    Summary
    EudraCT Number:2016-002302-39
    Sponsor's Protocol Code Number:RSV-M-301
    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:2016-08-05
    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 number2016-002302-39
    A.3Full title of the trial
    A Phase 3, Randomized, Observer-Blind, Placebo-Controlled, Group-Sequential Study to Determine the Immunogenicity and Safety of a Respiratory Syncytial Virus (RSV) F Nanoparticle Vaccine with Aluminum in Healthy Third-trimester Pregnant Women; and Safety and Efficacy of Maternally Transferred Antibodies in Preventing RSV Disease in their Infants
    Estudio en fase III, aleatorizado, enmascarado para el observador, controlado con placebo y con grupos secuenciales para determinar la inmunogenicidad y la seguridad de una vacuna de nanopartículas F del virus sincitial respiratorio (VSR) con aluminio en mujeres embarazadas sanas en su tercer trimestre, y para determinar la seguridad y la eficacia de los anticuerpos transferidos por la madre en la prevención de la enfermedad por el VSR en los lactantes.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Efficacy of Maternal Immunization with RSV F Vaccine in Preventing RSV Lower Respiratory Tract Infection in Young Infants
    Estudio para evaluar la eficacia de la inmunización maternal con vacuna F de VSR en la prevención de la infección por VSR en las vías respiratorias inferiores en recién nacidos.
    A.4.1Sponsor's protocol code numberRSV-M-301
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02624947
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNovavax, Inc.
    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 supportPartially funded by BMGF
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovavax, Inc.
    B.5.2Functional name of contact pointDaphne Papanicolaou
    B.5.3 Address:
    B.5.3.1Street Address20 Firstfield Road
    B.5.3.2Town/ cityGaithersburg MD
    B.5.3.3Post code20878
    B.5.3.4CountryUnited States
    B.5.4Telephone number0034917088600
    B.5.6E-mailDPapanicolaou@Novavax.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 nameAdjuvanted RSV F Vaccine
    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 INNRESPIRATORY SYNCYTIAL VIRUS FUSION PROTEIN
    D.3.9.3Other descriptive nameRESPIRATORY SYNCYTIAL VIRUS FUSION PROTEIN
    D.3.9.4EV Substance CodeSUB181711
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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 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
    Respiratory syncytial virus (RSV) is the leading viral cause of severe lower respiratory tract disease in infants and young children worldwide. In industrialized countries, nearly all children have been infected with RSV by 2 years of age. Most infected children present with mild upper respiratory tract symptoms, but a subset develops severe lower respiratory tract disease characterized by tachypnea, hyperinflation, crackles, and expiratory wheezing (i.e., bronchiolitis and pneumonia).
    El VSR es la principal causa vírica de enfermedad grave de las vías respiratorias bajas en lactantes y niños pequeños en todo el mundo. En los países industrializados, casi todos los niños se han infectado a la edad de 2 años. La mayoría presenta síntomas leves en las vías respiratorias altas, pero un subgrupo desarrolla una enfermedad grave de las vías respiratorias bajas caracterizada por taquipnea, hiper-insuflación, crepitantes y sibilancias espiratorias (es decir, bronquiolitis y neumonía).
    E.1.1.1Medical condition in easily understood language
    Lower respiratory tract disease in infants and young children
    Enfermedad de las vías respiratorias bajas en lactantes y niños pequeños.
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    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
    To determine the efficacy of maternal immunization with the RSV F vaccine against RSV lower respiratory tract infection (LRTI) with hypoxemia (peripheral capillary oxygen saturation [SpO2] < 95% at sea level or < 92% at altitudes > 1800 meters) through the first 90 days of life in infants of maternal RSV F vaccinees as compared to placebo recipients. In the event that efficacy is shown through the first 90 days of life, a hierarchical sequence of hypothesis tests will be carried out to examine efficacy at 120, 150, and 180 days of life.
    Determinar la eficacia de la vacunación materna con la vacuna F del VSR frente a infecciones de las vías respiratorias bajas (IVRB) con hipoxemia (SpO2< 95 % a nivel del mar o < 92 % a altitudes
    > 1800 metros) causadas por el VSR hasta los primeros 90 días de vida en lactantes de madres que han recibido la vacuna F del VSR en comparación con los receptores de placebo. En caso de que se demuestre la eficacia hasta los primeros 90 días de vida, se ejecutará una secuencia jerárquica de pruebas de hipótesis para examinar la eficacia a los 120, 150 y 180 días de vida.
    E.2.2Secondary objectives of the trial
    To determine the efficacy of maternal immunization with the RSV F vaccine in reducing the incidence of: RSV LRTI with severe hypoxemia (SpO2 < 92% at sea level or < 87% at altitudes > 1800 meters) or the need for high flow nasal cannula or mechanical ventilatory support, RSV LRTI leading to hospitalization, and resulting in death, through the first 90 days of life in infants of maternal RSV F vaccinees as compared to placebo recipients; to determine the efficacy of maternal immunization with the RSV F vaccine in reducing the incidence of all RSV LRTI through the first 90 days of life in infants of maternal RSV F vaccinees as compared to placebo recipients; to determine the efficacy of maternal immunization with the RSV F vaccine in reducing the incidence of healthcare interventions associated with wheezing through the first year of life in infants of maternal RSV F vaccinees as compared to placebo recipients.
    Determinar la eficacia de vacunación materna con vacuna F del VSR reduciendo incidencia de:
    IVRB con hipoxemia intensa (SpO2< 92 % a nivel del mar o < 87 % a altitudes > 1800 m) causada por el VSR o necesidad de cánula nasal de flujo alto o de soporte respiratorio mecánico, IVRB causada por VSR que requiere hospitalización, y que cause la muerte, hasta los primeros 90 días de vida en lactantes de madres que reciben vacuna F del VSR en comparación con las que reciben placebo; determinar la eficacia de vacunación materna con la vacuna F del VSR al reducir incidencia de IVRB causadas por VSR hasta los primeros 90 días de vida en lactantes de madres que reciban vacuna F del VSR en comparación con las que recibieron placebo; determinar la eficacia de vacunación materna con la vacuna F del VSR al reducir incidencia de intervenciones sanitarias asociadas a sibilancias hasta el primer año de vida en lactantes de madres que reciban vacuna F del VSR en comparación con las que recibieron placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) ≥ 18 and ≤ 40 years-of-age.
    2) Singleton pregnancy of 28 to 360/7 weeks gestation on the day of planned vaccination.
    3) Documentation of gestational age based on last menstrual period, physical exam, and ultrasound
    4) Documentation of a second or third (between 180/7 weeks and prior to randomization) trimester ultrasound with no major fetal anomalies identified.
    5) Good general maternal health as demonstrated by:
    o Medical history (including history of clinically significant adverse reactions to prior vaccines and allergies).
    o Physical examination including at least vital signs (blood pressure, pulse, respirations, and axillary body temperature); weight; height; examination of the HEENT, cardiovascular, pulmonary, gastrointestinal (abdominal), musculoskeletal, lymphatic, and dermatologic organ systems; and documentation of fetal heart tones. Note that abnormal vital signs may be repeated at the investigator’s discretion since these measures may be labile. Vital signs should be assessed in the context of normal values for the third trimester of pregnancy (see the Study Operations Manual).
    o Clinical laboratory parameters that include:
    o For the first year of study conduct in any country, normal/clinically insignificant blood urea nitrogen (BUN), creatinine, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, alkaline phosphatase (ALP), hemoglobin, white blood count, and platelet count. Note that normal ranges for clinical laboratory parameters will be based on reference ranges appropriate for the third trimester of pregnancy, specified in the toxicity grading scale (TGS, provided in the Study Operations Manual) and should be referenced to assess for any abnormalities. This testing should be performed by the central laboratory.
    o For all subjects, serologic exclusion of infection with hepatitis B (HBV) and C (HCV) viruses, syphilis and HIV as documented by testing (performed at the central or local laboratory) at screening or by medical records during the current pregnancy.
    6) Able to understand, and both willing and physically able to comply with study procedures. This includes anticipation of reasonable geographic proximity to the study clinic and adequate transportation to comply with scheduled and unscheduled study follow-up visits.
    7) Able and willing to provide written informed consent for themselves and infant.
    8) Estimated date of delivery (EDD) between approximately six (6) weeks before and approximately four (4) weeks after the historic average date of onset of increased RSV transmission at the clinical site using the best data available. The EDD is to be used as a general guidance for enrollment only; infants delivered outside this interval will not be excluded from analyses on the basis of this criterion. (Please refer to the Study Operations Manual for further guidance.)
    1) >= 18 y <= 40 años de edad.
    2) Embarazo monofetal de 28 a 360/7 semanas de gestación el día de la vacunación planeada.
    3) Documentación de la edad gestacional basada en el último periodo menstrual, exploración física y ecografía.
    4) Documentación de una ecografía del segundo o tercer trimestre (entre 180/7 semanas y antes de la aleatorización) en la que no se identifican anomalías fetales mayores.
    5) Buena salud general de la madre, demostrada por:
    o Antecedentes médicos (incluidas las reacciones adversas clínicamente significativas a vacunas anteriores y alergias).
    o Exploración física, que incluye como mínimo constantes vitales (presión arterial, pulso, frecuencia respiratoria y temperatura corporal axilar), peso, estatura, y exploración de cabeza, ojos y ORL y de los órganos y sistemas cardiovascular, pulmonar, gastrointestinal (abdominal), musculoesquelético, linfático y dermatológico, así como documentación de los tonos cardíacos fetales. Las mediciones de las constantes vitales deben repetirse en caso de anomalías, a criterio del investigador, ya que estas mediciones pueden ser lábiles. Las constantes vitales deberían evaluarse en el contexto de los valores normales para el tercer trimestre de la gestación (véase el Manual de operaciones del estudio).
    o Parámetros analíticos, que incluyen:
    - En el primer año de realización del estudio en cualquier país, nitrógeno ureico sanguíneo (BUN), creatinina, alanina-aminotransferasa (ALT), aspartato-aminotransferasa (AST), bilirrubina total, fosfatasa alcalina (FA), hemoglobina y recuento de leucocitos y plaquetas normales/clínicamente no significativos. Los intervalos normales de los parámetros analíticos se basarán en los intervalos de referencia adecuados para el tercer trimestre del embarazo, que se especifican en la escala de clasificación de la toxicidad (TGS, incluida en el Manual de operaciones del estudio). Deberán indicarse para evaluar cualquier anomalía. Esta analítica deberá realizarse en el laboratorio central.
    - En todas las madres, exclusión serológica de infección por virus de la hepatitis B (VHB) y C (VHC), sífilis y VIH, confirmada en la analítica (realizada en el laboratorio central o local) en la selección o mediante la historia clínica durante el embarazo actual.
    6) Capaz de comprender y estar dispuesta y ser físicamente capaz de cumplir con los procedimientos del estudio. Esto incluye la previsión de la proximidad geográfica razonable al centro del estudio y tener disponibilidad del transporte adecuado que permita cumplir con las visitas de seguimiento del estudio programadas y no programadas.
    7) Capaz y dispuesta a otorgar el consentimiento informado por escrito para sí misma y para su hijo.
    8) Fecha prevista de parto (FPP) entre aproximadamente seis (6) semanas antes y aproximadamente cuatro (4) semanas después de la fecha promedio histórica de inicio del aumento de transmisión del VSR en el centro médico, usando los mejores datos disponibles. LA FPP debe usarse como orientación general solo para la inclusión. Los lactantes nacidos fuera de este intervalo no se excluirán de los análisis basándose en este criterio. Para más orientación, consulte el Manual de operaciones del estudio.
    E.4Principal exclusion criteria
    1) Symptomatic cardiac or pulmonary disease requiring chronic drug therapy, including hypertension and asthma. Asthma is exclusionary if the subject is receiving chronic systemic glucocorticoids at any dose or inhaled glucocorticoids at any dose > 500 μg per day of beclamethasone or fluticasone, or > 800 μg per day of budesonide.
    2) Pregnancy complications (in the current pregnancy) such as preterm labor, hypertension (blood pressure [BP] > 140/90 in the presence of proteinuria or BP > 150/100 with or without proteinuria) or currently on an antihypertensive therapy or pre-eclampsia; or evidence of intrauterine growth restriction.
    3) Grade 2 or higher clinical laboratory or vital sign abnormality. Exclusion of subjects with grade 1 abnormalities will be based on the subject’s prior medical history and the investigator’s clinical judgment that the abnormality is indicative of a meaningful physiologic event.
    4) Receipt of any licensed vaccine (e.g., Tdap, inactivated influenza vaccine) within 14 days of study vaccination.
    5) Received any RSV vaccine at any time.
    6) Body mass index (BMI) of ≥ 40, at the time of the screening visit.
    7) Hemoglobinopathy (including known sickle trait or thalassemias, even if asymptomatic) or blood dyscrasias.
    8) Hepatic or renal dysfunction.
    9) Established diagnosis of seizure disorder, regardless of therapy.
    10) Known, active auto-immune disease or immunodeficiency syndrome.
    11) Endocrine disorders, including (but not limited to) untreated hyperthyroidism, untreated hypothyroidism (unless due to auto-immune disease), and glucose intolerance (e.g., diabetes mellitus type 1 or 2) antedating pregnancy, or occurring during pregnancy and requiring interventions other than diet for control.
    12) History of major gynecologic or major abdominal surgery, including bariatric surgery (previous Caesarean section is not an exclusion).
    13) Known HIV, syphilis, HBV, or HCV infection, as assessed by serologic tests conducted during the current pregnancy or as a procedure during the screening period of the study.
    14) Primary genital Herpes simplex virus (HSV) infection during the current pregnancy.
    15) Current alcohol or drug abuse based on the investigator’s knowledge of present or recent (within the last 2 years) use/abuse of alcohol or illegal or non-prescription drugs.
    16) Documentation that the current pregnancy results from in vitro fertilization (IVF).
    17) Documentation that the current pregnancy results from rape or incest.
    18) Documentation that the infant will be a ward of the state or be released for adoption.
    19) History/presence of deep venous thrombosis or thromboembolism, or the use of anticoagulants during pregnancy (use of low-dose aspirin as prophylaxis [e.g., for the prevention of morbidity and mortality from preeclampsia] is acceptable in dosages consistent with local standards of care).
    20) Untreated red blood cell allo-immunization.
    21) Prior stillbirth or neonatal death, or multiple (≥ 3) spontaneous abortions.
    22) Prior preterm delivery ≤ 34 weeks gestation or having ongoing intervention (medical/surgical) in current pregnancy to prevent preterm birth.
    23) Greater than five (5) prior deliveries.
    24) Previous infant with a known genetic disorder or major congenital anomaly.
    25) Receipt of investigational drugs or immune globulins (with the exception of prophylactic anti-Rho D immune globulin) within six (6) months prior to the administration of the study vaccine.
    26) Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccine. An immunosuppressant dose of glucocorticoid will be defined as a systemic dose ≥ 10 mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted except for the limit established in exclusion criterion #1.
    27) Neuro-psychiatric illness, including a history of severe post-partum depression, deemed likely to interfere with protocol compliance, safety reporting, or receipt of pre-natal care; or requiring treatment with psychotropic drugs (excluding treatment for depression and anxiety).
    28) Any other physical, psychiatric or social condition which may, in the investigator’s opinion, increase the risks of study participation to the maternal subject or the fetus/infant; or may lead to the collection of incomplete or inaccurate safety data.
    29) Acute disease within 72 hours of the day of the planned vaccination (defined as the presence of a moderate or severe illness with or without fever, or an axillary body temperature > 38.0°C).
    30) History of a serious adverse reaction (e.g., anaphylaxis) to any prior vaccine.
    1) Enfermedad cardíaca o pulmonar sintomática que requiera tratamiento farmacológico de larga duración, incluidas hipertensión y asma. El asma será motivo de exclusión si la madre está recibiendo glucocorticoides sistémicos en tratamientos de larga duración en cualquier dosis o glucocorticoides inhalados en cualquier dosis > 500 µg al día de beclometasona o fluticasona, o > 800 μg al día de budesonida.
    2) Complicaciones de la gestación (en la gestación actual) como parto pretérmino, hipertensión (presión arterial [PA] > 140/90 con proteinuria o PA > 150/100 con o sin proteinuria) o tratamiento antihipertensivo actual, o preeclampsia o indicios de restricción del crecimiento intrauterino.
    3) Anomalía de grado 2 o mayor en la analítica o las constantes vitales. La exclusión de madres con anomalías de grado 1 se basará en sus antecedentes médicos y en criterio clínico del investigador, según los cuales dicha anomalía indica un acontecimiento fisiológico significativo.
    4) Recepción de cualquier vacuna aprobada en los 14 días anteriores a la vacunación del estudio.
    5) Recepción de cualquier vacuna para VSR en cualquier momento.
    6) Índice de masa corporal (IMC) >= 40 en el momento de la visita de selección.
    7) Hemoglobinopatía (incluido diagnóstico de rasgo falciforme o talasemias, incluso si son asintomáticos) o discrasias sanguíneas.
    8) Disfunción hepática o renal.
    9) Diagnóstico confirmado de trastorno convulsivo, con independencia del tratamiento.
    10) Enfermedad autoinmune o síndrome de inmunodeficiencia activos conocidos.
    11) Trastornos endocrinos, incluidos (entre otros), el hiper /hipotiroidismo no tratado (salvo que este último se deba a una enfermedad autoinmune) y la intolerancia a la glucosa anterior a gestación, o que se presente durante la misma y requiera intervenciones distintas de la dieta para su control.
    12) Antecedentes de cirugía mayor ginecológica o abdominal, incluida la cirugía bariátrica (cesárea previa no es motivo de exclusión).
    13) Diagnóstico de infección por VIH, sífilis/VHB/VHC, evaluado mediante análisis serológicos realizados durante la gestación actual o como procedimiento durante el período de selección
    del estudio.
    14) Infección primaria por herpes simple (VHS) genital durante la gestación actual.
    15) Abuso actual de alcohol o drogas según conocimiento del investigador de uso o abuso presente o reciente (en los 2 últimos años) de alcohol o sustancias ilegales o fármacos no recetados.
    16) Documentación de que la gestación actual es consecuencia de fertilización in vitro (FIV).
    17) Documentación de que el embarazo actual es consecuencia de violación o incesto.
    18) Documentación de que el lactante quedará bajo la tutela del Estado o será dado en adopción.
    19) Antecedentes o presencia de trombosis venosa profunda o tromboembolia, o uso de anticoagulantes durante embarazo (el uso de ácido acetilsalicílico en dosis bajas como profilaxis es aceptable en dosis compatibles con tratamiento de referencia local).
    20) Aloinmunización eritrocitaria no tratada.
    21) Feto muerto o muerte neonatal previa, o abortos espontáneos múltiples (>= 3).
    22) Parto pretérmino previo <=34 semanas de gestación o una intervención continuada (médica o quirúrgica) en la gestación actual para prevenir parto pretérmino.
    23) Más de 5 alumbramientos anteriores.
    24) Otro lactante con trastorno genético conocido o anomalía congénita mayor.
    25) Recepción de fármacos en investigación o de inmunoglobulinas (con excepción de inmunoglobulina anti-Rho D profiláctica) en los 6 meses previos a la administración de vacuna del estudio.
    26) Administración de larga duración (definida como más de 14 días seguidos) de inmunodepresores u otros fármacos modificadores de la inmunidad en los 6 meses anteriores a administración de la vacuna del estudio. La dosis inmunodepresora de un glucocorticoide se definirá como una dosis sistémica >= 10 mg de prednisona al día o equivalente. Se permitirá uso de glucocorticoides tópicos, inhalados y nasales, salvo con límite establecido en criterio de exclusión n.°1.
    27) Enfermedad neuropsiquiátrica, incluido antecedente de depresión grave posparto, cuando se considere probable que interfiera con cumplimiento del protocolo, las notificaciones de seguridad o la recepción de los cuidados prenatales, o que requiera tratamiento con psicotropos (excluido el tratamiento de depresión y ansiedad).
    28) Cualquier otra afección física, psiquiátrica o social que pudiera, en opinión del investigador, aumentar riesgo de participación en el estudio para la madre o el feto/lactante, o que pudiera conducir a recopilación de datos de seguridad incompletos o imprecisos.
    29) Enfermedad aguda en las 72 horas anteriores al día de vacunación planeada (definida como presencia de una enfermedad moderada o grave con o sin fiebre, o una temperatura corporal axilar > 38,0 °C).
    30) Antecedentes de reacción adversa grave a cualquier vacuna anterior.
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of RSV LRTI with hypoxemia (SpO2 < 95% at sea level or < 92% at altitudes > 1800 meters) in infants through 90 days of life. The primary analysis will consider term infants (≥ 37 weeks of gestation at delivery) of mothers who received test article ≥ 2 weeks prior to delivery. Analyses at 120, 150, and 180 days of age will be performed dependent on successful outcomes at the prior, shorter intervals.
    Incidence of RSV LRTI with hypoxemia (SpO2 < 95% at sea level or < 92% at altitudes > 1800 meters) in infants through 90 days of life. The primary analysis will consider term infants (>= 37 weeks of gestation at delivery) of mothers who received test article >= 2 weeks prior to delivery. Analyses at 120, 150, and 180 days of age will be performed dependent on successful outcomes at the prior, shorter intervals.
    E.5.1.1Timepoint(s) of evaluation of this end point
    90 days of age
    90 días de edad
    E.5.2Secondary end point(s)
    • Incidence of RSV LRTI with severe hypoxemia (SpO2 < 92% at sea level or < 87% at altitudes > 1800 meters) or the need of high flow nasal cannula or mechanical ventilatory support in infants through 90 days of life,
    • Incidence of RSV LRTI with hospitalization in infants through 90 days of life,
    • Incidence of RSV LRTI resulting in death in infants through 90 days of life,
    • Incidence of RSV LRTI (all severities) in infants through 90 days of life.
    • Incidence of healthcare interventions associated with wheezing through the first year of life.
    A subgroup analysis for all efficacy endpoints will consider all infants of mothers who received test article < 2 weeks prior to delivery and all infants of mothers who received any test article. For all secondary efficacy endpoints, analyses at 120, 150, and 180 days of age will be performed dependent on successful outcomes at the prior, shorter intervals.
    • Incidencia de IVRB con hipoxemia intensa (SpO2< 92 % a nivel del mar o < 87 % a altitudes
    > 1800 metros) causada por el VSR o necesidad de una cánula nasal de flujo alto o de soporte respiratorio mecánico en lactantes hasta los 90 días de vida.
    • Incidencia de IVRB causada por el VSR que requiere hospitalización en lactantes hasta los 90 días
    de vida.
    • Incidencia de IVRB causada por el VSR que cause la muerte de los lactantes hasta los 90 días de vida.
    • Incidencia de IVRB causada por el VSR (todas las intensidades) en lactantes hasta los 90 días de vida.
    • Incidencia de intervenciones del personal sanitario asociadas a sibilancias hasta el primer año de vida.
    En un análisis de subgrupos de todos los criterios de valoración de la eficacia se tendrá en cuenta a todos los lactantes de madres que reciban el producto en estudio < 2 semanas antes del parto y de todos los lactantes de madres que reciban cualquier producto del estudio. Para todos los criterios de valoración secundarios de eficacia, los análisis a los 120, 150 y 180 días de edad se realizarán en función de los resultados de éxito en los intervalos previos más cortos.
    E.5.2.1Timepoint(s) of evaluation of this end point
    90 days of age
    90 días de edad
    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 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 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 No
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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
    Belgium
    Chile
    France
    Germany
    Italy
    Mexico
    Mozambique
    Netherlands
    New Zealand
    Philippines
    South Africa
    Spain
    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
    Last visit of the last subject
    Última visita del ultimo paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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: 8618
    F.1.1.1In Utero Yes
    F.1.1.1.1Number of subjects for this age range: 8618
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) Yes
    F.1.1.3.1Number of subjects for this age range: 8618
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 8618
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 8618
    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 No
    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 Yes
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state300
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 900
    F.4.2.2In the whole clinical trial 8618
    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 Decision2016-09-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-07-12
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