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    Summary
    EudraCT Number:2017-004233-86
    Sponsor's Protocol Code Number:V160-002
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-06-27
    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 number2017-004233-86
    A.3Full title of the trial
    Double-Blind, Randomized, Placebo-Controlled Phase 2b, Multi-center Study to Evaluate the Safety, Tolerability, Efficacy and Immunogenicity of a 2-Dose and a 3- Dose Regimen of V160 (Cytomegalovirus [CMV] Vaccine) in Healthy Seronegative Women, 16 to 35 Years of Age
    Estudio de fase 2b, multicéntrico, aleatorizado, doble ciego y controlado con placebo para evaluar la seguridad, la tolerabilidad, la eficacia y la inmunogenicidad de una pauta de 2 y 3 dosis de V160 (vacuna contra el citomegalovirus [CMV]) en mujeres sanas seronegativas de 16 a 35 años de edad
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    V160 2-Dose and 3-Dose Regimens vs. Placebo in Healthy CMV Seronegative Females
    Regímenes de 2 y 3 dosis de V160 frente a placebo en mujeres sanas seronegativas para CMV
    A.3.2Name or abbreviated title of the trial where available
    V160 2-Dose and 3-Dose Regimens vs. Placebo in Healthy CMV Seronegative Females
    Regímenes de 2 y 3 dosis de V160 frente a placebo en mujeres sanas seronegativas para CMV
    A.4.1Sponsor's protocol code numberV160-002
    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 SponsorMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., 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 supportMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Sharp & Dohme de España S.A.
    B.5.2Functional name of contact pointInvestigación Clínica
    B.5.3 Address:
    B.5.3.1Street AddressC/ Josefa Valcárcel, 38
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28037
    B.5.3.4CountrySpain
    B.5.4Telephone number+34913210600
    B.5.5Fax number+34913210590
    B.5.6E-mailensayos_clinicos@merck.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 nameHuman Cytomegalovirus (HCMV) Vaccine
    D.3.2Product code V160
    D.3.4Pharmaceutical form Lyophilisate for 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 INNV160
    D.3.9.2Current sponsor codeV160
    D.3.9.3Other descriptive nameV160
    D.3.9.4EV Substance CodeSUB191823
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/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 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 nameMAPA Diluent
    D.3.4Pharmaceutical form Suspension 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 INNALUMINIUM PHOSPHATE
    D.3.9.3Other descriptive nameALUMINIUM PHOSPHATE
    D.3.9.4EV Substance CodeSUB12462MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number450
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 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
    Cytomegalovirus infection (CMVi)
    Infección citomegalovirus (icCMV)
    E.1.1.1Medical condition in easily understood language
    Prevention of cytomegalovirus infection in healthy females between 16 and 35 years of age
    Prevención de la infección por citomegalovirus en mujeres sanas de entre 16 y 35 años de edad
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10009703
    E.1.2Term CMV infection
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To demonstrate the efficacy of a 3-dose regimen of V160 in reducing the incidence of primary CMVi during the follow-up period after the last dose of the vaccine
    2. To assess the safety and tolerability of a 2-dose and a 3-dose regimen of V160
    1. Demostrar la eficacia de una pauta de 3 dosis de V160 para reducir la incidencia de iCMV primaria durante el período de seguimiento después de la última dosis de la vacuna
    2. Evaluar la seguridad y la tolerabilidad de una pauta de 2 y 3 dosis de V160
    E.2.2Secondary objectives of the trial
    To demonstrate the efficacy of a 2-dose regimen of V160 in reducing the incidence of primary CMVi during the follow-up period after the last dose of the vaccine
    Demostrar la eficacia de una pauta de 2 dosis de V160 para reducir la incidencia de iCMV primaria durante el período de seguimiento después de la última dosis de la vacuna
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Merck will conduct Future Biomedical Research on DNA (Blood), saliva and urine specimens collected during this clinical trial. Such research is for biomarker testing to address emergent questions not described elsewhere in the protocol (as part of the main trial) and will only be conducted on specimens from appropriately consented subjects. The objective of collecting specimens for Future Biomedical Research is to explore and identify biomarkers that inform the scientific understanding of diseases and/or their therapeutic treatments. The overarching goal is to use such information to develop safer, more effective drugs, and/or to ensure that subjects receive the correct dose of the correct drug at the correct time
    Merck llevará a cabo Investigaciones Biomédicas Futuras con las muestras de ADN (Sangre), saliva y orina recogidas en este estudio clínico. Estas investigaciones tendrán por objeto el análisis de biomarcadores con el fin de abordar aspectos nuevos que no se describen en otras secciones del protocolo (como parte del estudio principal) y solo se llevarán a cabo en muestras de las participantes que hayan otorgado el consentimiento correspondiente. El objetivo de la obtención de muestras para Investigaciones Biomédicas Futuras consiste en estudiar e identificar biomarcadores que proporcionen información a los científicos sobre las enfermedades o sus tratamientos . El objetivo último es utilizar tal información para desarrollar fármacos más seguros y eficaces y/o para garantizar que las participantes reciban la dosis correcta del fármaco correcto en el momento preciso
    E.3Principal inclusion criteria
    1) Healthy, based on medical history and physical examination
    2) Female, 16 to 35 years of age
    3) Serologically confirmed as CMV seronegative (based on CMV IgG) prior to receiving the first dose of V160/placebo
    4) Have direct exposure to young children (<5 years of age) at home or occupationally
    5) Childbearing potential
    6) Agrees to avoid becoming pregnant during the 6-month treatment phase and for 4 weeks after the last dose of V160/placebo (from Day 1 through Month 7) by either practicing abstinence from heterosexual activity OR by using 2 allowable methods of birth control during heterosexual activity.
    7) Voluntarily agrees to participate (or legally acceptable representative, for minors, if applicable); and provide written informed consent/assent for the trial. The participant may also provide consent/assent for Future Biomedical Research. However the participant may participate in the main trial without participating in Future Biomedical Research
    8) Be able to complete all scheduled visits and to comply with the study procedures
    9) Agrees to provide study personnel with a primary telephone number as well as an alternate form of contact, if available, for follow-up purposes
    1) Una buena salud, según la historia clínica y la exploración física
    2) Mujeres de 16 a 35 años de edad
    3) Confirmación de un resultado seronegativo para el CMV (mediante análisis de IgG contra CMV) antes de recibir la primera dosis de V160/placebo
    4) Exposición directa a niños pequeños (< 5 años de edad) en casa o en el trabajo
    5) Capacidad de procrear
    6) Compromiso de evitar el embarazo durante los 6 meses de la fase de tratamiento y hasta 4 semanas después de la última dosis de V160/placebo (desde el día 1 hasta el mes 7) por abstinencia de relaciones heterosexuales O utilización de 2 métodos anticonceptivos permitidos durante las relaciones heterosexuales
    7) La participante (o su representante legal si es menor de edad, cuando proceda) accede voluntariamente a participar y otorga su consentimiento/asentimiento informado por escrito para el ensayo. La participante también podrá otorgar su consentimiento/asentimiento para investigaciones biomédicas futuras. No obstante, podrá participar en el ensayo principal sin necesidad de hacerlo en las investigaciones biomédicas futuras
    8) La participante puede acudir a todas las visitas programadas y cumplir los procedimientos del estudio
    9) La participante se compromete a facilitar al personal del estudio un número de teléfono principal y otra forma alternativa de contacto, si procede, para fines de seguimiento
    E.4Principal exclusion criteria
    1. Has a history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might expose the participant to risk by participating in the trial, confound the results of the trial, or interfere with participation for the full duration of the trial, as assessed by the investigator
    2. Has a history of any allergic reaction or an anaphylactic/anaphylactoid reaction to any vaccination that required medical intervention, or of any severe allergic reaction (eg, swelling of the mouth and throat, difficulty breathing, hypotension, or shock), to any vaccine component that required medical intervention
    3. Has a recent (<72 hours) history of febrile illness (temperature ≥100.4°F/38.0°C, oral equivalent)
    4. Is currently immunocompromised or has been diagnosed as having a congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition. No testing for HIV will be required in the study
    5. Has a condition in which repeated venipuncture or injections pose more than minimal risk for the participant, such as hemophilia, thrombocytopenia, other severe coagulation disorders, or significantly impaired venous access
    6. A woman of childbearing potential (WOCBP) who has a positive pregnancy test at screening or within 24 hours before the first dose of study treatment. If the urine test on the day of vaccination cannot be confirmed as negative, a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. If pregnancy is diagnosed any time after the first dose but before the completion of the vaccination series, the participant is excluded from any remaining vaccinations but is included in the study for safety follow-up
    7. Has previously received a CMV vaccine
    8. Had any live virus vaccine administered or scheduled to be administered in the period from 4 weeks prior to, and 4 weeks following receipt of any dose of trial vaccine
    9. Had any inactivated vaccine administered or scheduled within the period from 14 days prior to, through 14 days following, any dose of trial vaccine
    10. Had administration of any immune globulin or blood product within 90 days prior to injection with V160/placebo or scheduled within 30 days thereafter
    11. Has received systemic corticosteroids (equivalent of ≥2 mg/kg total daily dose of prednisone or ≥20 mg/d for persons weighing >10 kg) for ≥14 consecutive days and has not completed treatment at least 30 days prior to trial entry
    12. Has received systemic corticosteroids exceeding physiologic replacement doses (≈5 mg/d prednisone equivalent) within 14 days prior to the first vaccination (participants using inhaled, nasal, or topical steroids are considered eligible for the trial)
    13. Has received any anti-viral agent with proven or potential activity against CMV two weeks prior to vaccination or is likely to receive such an agent within 2 weeks after vaccination. Anti-viral agents prohibited include letermovir, ganciclovir, valganciclovir, foscarnet, cidofovir, and valacyclovir.
    14. Is receiving or has received in the year prior to enrollment immunosuppressive therapies including but not limited to rapamycin (also sirolimus), tacrolimus (also FK-506 or Fujimycin), or other therapies used for solid organ/cell transplant, radiation therapy, immunosuppressive/cytotoxic immunotherapy, chemotherapy and other immunosuppressive therapies known to interfere with the immune response. Topical tacrolimus is allowed provided that it is not used within 2 weeks prior to, or 2 weeks following a V160 dose
    15. Has participated in another clinical trial in the past 4 weeks, or plans to participate in a treatment-based trial or a trial in which an invasive procedure is to be performed while enrolled in this trial. (Participation in a safety surveillance or non-interventional trial is acceptable)
    16. Planned donation of eggs at any time from signing the informed consent through 1 month after receiving the last dose of the trial V160/placebo
    17. Is or has an immediate family member (eg, spouse, parent/legal guardian, sibling or child) who is investigational site or sponsor staff directly involved with this study
    18. Any other reason that in the opinion of the investigator might interfere with the evaluation required by the study
    1. Tener antecedentes o signos actuales de cualquier proceso, tratamiento, anomalía analítica u otra circunstancia que pueda exponer a la participante a un riesgo elevado por participar en el ensayo, confundir los resultados del ensayo o interferir en su participación durante todo el ensayo, según lo de terminado por el investigador
    2. Tener antecedentes de cualquier reacción alérgica o reacción anafiláctica/anafilactoide a una vacuna que precisara una intervención médica, o de cualquier reacción alérgica grave (p. ej., hinchazón de la boca y la garganta, dificultad para respirar, hipotensión o shock) al componente de una vacuna que precisara una intervención médica
    3. Tener antecedentes recientes (< 72 horas) de enfermedad febril (temperatura ≥ 38,0 °C, equivalente bucal)
    4. Estar inmunodeprimida o haber sido diagnosticada de una inmunodeficiencia congénita o adquirida, infección por el virus de la inmunodeficiencia humana (VIH), linfoma, leucemia, lupus eritematoso sistémico, artritis reumatoide, artritis reumatoide juvenil, enfermedad inflamatoria intestinal u otra enfermedad autoinmunitaria. No será necesario realizar análisis del VIH en el estudio
    5. Tener un trastorno que haga que la venopunción o las inyecciones repetidas supongan un riesgo más que mínimo para la participante, como hemofilia, trombocitopenia, otros trastornos graves de la coagulación o alteración significativa del acceso venoso
    6. Ser una mujer en edad fértil (MEF) (véase el apéndice 3) con un resultado positivo en una prueba de embarazo realizada en la selección o en las 24 horas previas a la primera dosis del tratamiento del estudio. Cuando no pueda confirmarse un resultado negativo de la prueba de embarazo en orina, será necesario hacer una prueba de embarazo en suero. En tal caso, la participante será excluida si el resultado de la prueba de embarazo en suero es positivo. Si se diagnostica un embarazo en cualquier momento después de la primera dosis, pero antes de completar la serie de vacunaciones, se excluirá a la participante de las vacunaciones restantes, pero se la incluirá en el estudio para el seguimiento de la seguridad
    7. Haber recibido previamente una vacuna contra el CMV
    8. Haber recibido o tener programada una vacuna de virus vivos en el período comprendido entre 4 semanas antes y 4 semanas después de recibir cualquiera de las dosis de la vacuna del ensayo
    9. Haber recibido o tener programada una vacuna de virus inactivados durante el período comprendido entre 14 días antes y 14 días después de recibir cualquiera de las dosis de la vacuna del estudio
    10. Haber recibido o tener programada en los 30 días siguientes la administración de cualquier inmunoglobulina o hemoderivado en los 90 días previos a la inyección de V160/placebo
    11. Haber recibido corticoides sistémicos (equivalentes a una dosis diaria total ≥ 2 mg/kg de prednisona o ≥ 20 mg/día en personas con un peso > 10 kg) durante 14 días consecutivos o más y no haber completado el tratamiento al menos 30 días antes de la incorporación al ensayo
    12. Haber recibido corticosteroides sistémicos que superen las dosis de reposición fisiológica (se consideran elegibles para el ensayo los pacientes con un equivalente de prednisona ≈ 5 mg/día) en los 14 días previos a la primera vacunación (las participantes que utilicen esteroides inhalados, nasales o tópicos podrán participar en el ensayo)
    13. Haber recibido cualquier antiviral con actividad demostrada o potencial contra el CMV dos semanas antes de la vacunación o tener probabilidad de recibir dicho fármaco en las 2 semanas siguientes a la vacunación. Los antivirales prohibidos son letermovir, ganciclovir, valganciclovir, foscarnet, cidofovir y valaciclovir
    14. Estar recibiendo o haber recibido en el año previo a la inclusión tratamientos inmunodepresores, como rapamicina (también sirolimús), tacrólimus (también FK-506 o Fujimicina) u otros tratamientos utilizados para trasplante de órganos sólidos/células, radioterapia, inmunoterapia inmunodepresora/citotóxica, quimioterapia y otros tratamientos inmunodepresores que se sabe que interfieren con la respuesta inmunitaria. Se permite el uso tópico de tacrólimus siempre que no se utilice en las 2 semanas previas ni en 2 semanas siguientes a la dosis de V160
    15. Haber participado en otro ensayo clínico en las 4 últimas semanas, o tener pensado participar en un ensayo con tratamiento o en un ensayo en el que se vaya a realizar un procedimiento invasivo durante su participación en este ensayo. (Se acepta la participación en un estudio de vigilancia de la seguridad o sin ninguna intervención)
    16. Tener prevista la donación de óvulos en cualquier momento desde la firma del consentimiento informado hasta 1 mes después de recibir la última dosis del ensayo V160/placebo
    Leer resto en el protocolo
    E.5 End points
    E.5.1Primary end point(s)
    1. Efficacy: number of participants with CMVi in the V160 3- dose regimen and placebo arms
    2. Safety: number of participants experiencing solicited injection site AEs within Days 1 through 5 after each vaccination visit; solicited systemic AEs and vaccine related serious AEs within Days 1 through 14 after each vaccination visit
    1. Eficacia: Incidencia de iCMV en el grupo de 3 dosis de vacuna y en el grupo de placebo
    2. Seguridad: número de sujetos que presenten los AA en el lugar de inyección especificados entre los días 1 y 5 después de cada visita de vacunación; los AA sistémicos especificados; y AAG relacionados con la vacuna entre los días 1 y 14 después de cada visita de vacunación
    E.5.1.1Timepoint(s) of evaluation of this end point
    Analysis is endpoint-driven. An interim analysis (IA) for the purpose of testing the primary efficacy hypothesis will be conducted upon accrual of a total of 15 CMVi endpoint cases. It is anticipated that the required 15 cases will be accumulated at ≈18 months after enrollment of the first study participant.
    Se realizará un análisis intermedio (AI) para contrastar la hipótesis principal sobre la eficacia tras la acumulación de 15 casos totales de iCMV. Se prevé que se habrán acumulado los 15 casos necesarios aproximadamente 18 meses después de la inclusión de la primera participante en el estudio
    E.5.2Secondary end point(s)
    Efficacy: number of participants with CMVi in the V160 2-dose regimen and placebo arms
    Eficacia: Incidencia de iCMV en el grupo de 2 dosis de vacuna y en el grupo de placebo
    E.5.2.1Timepoint(s) of evaluation of this end point
    There is only one final analysis of the secondary efficacy endpoint. However, the testing of the secondary efficacy hypothesis may occur at the time of the IA or the final analysis of the primary efficacy hypothesis. The secondary efficacy hypothesis will only be tested if the primary efficacy hypothesis is successfully demonstrated.
    Solo hay un análisis final en la hipótesis secundaria sobre la eficacia. Sin embargo, el análisis de la hipótesis secundaria sobre la eficacia puede ocurrir al mismo tiempo que el análisis intermedio o el análisis final de la hipótesis primaria de eficacia. La hipótesis secundaria sobre la eficacia solo será analizado si la hipótesis primaria sobre la eficacia es satisfactoriamente demostrada
    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 Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    inmunogenicidad
    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) 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 trial3
    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 EEA14
    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
    Canada
    Finland
    Israel
    Russian Federation
    Spain
    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
    LVLS
    LVLS
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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: 100
    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) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 100
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 2000
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 Yes
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state127
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 377
    F.4.2.2In the whole clinical trial 2100
    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 Decision2018-06-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-22
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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