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    Summary
    EudraCT Number:2019-000607-33
    Sponsor's Protocol Code Number:200075
    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:2019-04-30
    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 number2019-000607-33
    A.3Full title of the trial
    A Phase II, randomized, open-label, multicentre study to assess the reactogenicity, safety and immunogenicity of GSK’s paediatric Herpes Zoster subunit candidate vaccine (PED-HZ/su) when administered intramuscularly on a two-dose schedule to immunocompromised paediatric renal transplant recipients from 1 to 17 years of age.
    Estudio de fase II, aleatorizado, abierto y multicéntrico para evaluar la reactogenicidad, seguridad e inmunogenicidad de la vacuna pediátrica candidata de subunidades de herpes zóster (PED-HZ/su) de GSK tras su administración intramuscular con una pauta de dos dosis a niños inmunodeprimidos receptores de trasplante renal de 1-17 años de edad.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to test GlaxoSmithKline’s (GSK) candidate vaccine-GSK1437173A for prevention of shingles in children with kidney transplant
    Estudio de GSK de reactogenicidad, seguridad e inmunogenicidad de la vacuna pediátrica candidata de subunidades del herpes zóster (PED-HZ/su) GSK143713A en niños inmunodeprimidos receptores de trasplante renal
    A.3.2Name or abbreviated title of the trial where available
    ZOSTER-047
    ZOSTER-047
    A.4.1Sponsor's protocol code number200075
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/222/2018
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGlaxoSmithKline S.A.
    B.1.3.4CountrySpain
    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 supportGlaxoSmithKline Biologicals
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline S.A.
    B.5.2Functional name of contact pointCENTRO DE INFORMACIÓN
    B.5.3 Address:
    B.5.3.1Street AddressSevero Ochoa 2
    B.5.3.2Town/ cityTres Cantos (Madrid)
    B.5.3.3Post code28760
    B.5.3.4CountryBelgium
    B.5.4Telephone number34902202700
    B.5.5Fax number34918070479
    B.5.6E-mailes-ci@gsk.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 namePED-HZ/su (Pediatric Herpes Zoster subunit (HZ/su) vaccine)
    D.3.2Product code gE (50µg) + AS01E
    D.3.4Pharmaceutical form Powder and suspension for suspension for injection
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVaricella Zoster Virus glycoprotein E antigen
    D.3.9.2Current sponsor codegE antigen
    D.3.9.3Other descriptive nameRECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E
    D.3.9.4EV Substance CodeSUB31416
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Herpes Zoster
    Renal transplant
    Pediatric population
    Herpes Zoster
    Trasplante renal
    Población pediátrica
    Este producto está destinado a la prevención del herpes zóster (HZ) en sujetos
    inmunodeprimidos de 1 a 17 años de edad.
    E.1.1.1Medical condition in easily understood language
    Shingles
    Culebrillas
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    •To evaluate reactogenicity (up to Day 7) and safety (up to Month 2) following administration of PED-HZ/su in each age category (1-11 and 12-17 years)
    •To evaluate humoral immune responses following administration of PED-HZ/su in each age category (1-11 and 12-17 years) at Month 2
    •Evaluar la reactogenicidad (hasta el día 7) y la seguridad (hasta el mes 2) después de la administración de PED-HZ/su en cada categoría etaria (1-11 y 12-17 años)
    •Evaluar las respuestas inmunitarias humorales después de la administración de PED-HZ/su en cada categoría etaria (1-11 y 12-17 años) en el mes 2.
    E.2.2Secondary objectives of the trial
    •To evaluate safety following administration of PED-HZ/su in each age category (1-11 and 12-17 years) from Day 1 up to Month 13
    •To describe the occurrence of cases of HZ in each age category (1-11 and 12-17 years)
    •To evaluate reactogenicity and safety for the entire study population (1-17 years) following administration of PED-HZ/su
    •To characterise humoral immune responses following administration of PED-HZ/su
    •Evaluar la seguridad después de la administración de PED-HZ/su en cada categoría etaria (1-11 y 12-17 años) desde el día 1 hasta el mes 13.
    •Describir la frecuencia de casos de HZ en cada categoría de edad (1-11 y 12-17 años).
    •Evaluar la reactogenicidad y la seguridad para toda la población del estudio (1-17 años) después de la administración de PED-HZ/su.
    •Caracterizar las respuestas inmunitarias humorales después de la administración de PED-HZ/su
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Subjects’ parent(s)/Legally Acceptable Representative(s) [LAR(s) who, in the opinion of the investigator, can and will comply, with the requirements of the protocol
    •Written or witnessed/thumb printed informed consent obtained from the parent(s)/LAR(s) of the subject prior to performance of any study specific procedure.
    •Written informed assent obtained from the subjects when applicable according to local requirements.
    •A male or female between, and including, 1 and 17 years of age at the time of randomisation (Visit Day 1)
    •Body weight ≥ 6 kg/13.23 pounds.
    •A subject is eligible if they meet at least one of the following criteria:
    -Documented previous VZV vaccination OR
    -Medically verified varicella OR
    -Seropositive for VZV prior to transplantation.
    •Subjects with renal transplant more than six months (180 days) prior randomization (Visit Day 1)
    •Subject who has received an ABO compatible allogeneic renal transplant (allograft).
    •Subject with stable renal function with stability defined as <20% variability between the last two creatinine measurements or calculated glomerular filtration rate (GFR) or based on investigator opinion after review of multiple creatinine measurements or calculated GFRs.
    •Subject receiving maintenance immunosuppressive therapy for the prevention of allograft rejection for a minimum of one month (30 days) prior to randomization (Visit Day 1).
    •Female subjects of childbearing potential may be enrolled in the study, if the subject
    -has practiced adequate contraception for 30 days prior to Visit Day 1 and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series
    •Padres/representantes legales (RL) de sujetos que, en opinión del investigador puedan y vayan a cumplir los requisitos del protocolo
    •Consentimiento informado firmado o suscrito ante testigos/firmado con la huella digital de los padres/RL del sujeto antes de realizar ningún procedimiento específico.
    •Asentimiento informado firmado por los sujetos según proceda, de acuerdo con los requisitos locales.
    •Varones y mujeres de entre 1 y 17 años, ambos inclusive, en el momento de la aleatorización (visita del día 1).
    •Peso corporal ≥ 6 kg/13,23 libras.
    •Un sujeto se considera elegible si cumple al menos uno de los siguientes criterios:
    -Vacunación previa frente al VZV documentada O
    -Varicela verificada por un médico O
    -Seropositividad para VZV antes del trasplante.
    •Sujetos sometidos a trasplante renal más de seis meses (180 días) antes de la aleatorización (visita del día 1).
    •Sujetos que hayan recibido un trasplante renal alogénico (aloinjerto) ABO compatible.
    •Sujetos con función renal estable, definiendo la estabilidad como una variabilidad <20 % entre las dos últimas mediciones de la creatinina o de la tasa de filtración glomerular calculada (TFG) osegún el criterio del investigador después del análisis de múltiples mediciones de la creatinina o de la TFG calculada.
    •Sujetos que lleven con tratamiento inmunosupresor de mantenimiento (consultar definición en el glosario de términos del protocolo) para la prevención del rechazo del aloinjerto durante un mínimo de un mes (30 días) antes de la aleatorización (visita del día 1).
    •Se podrá reclutar en este estudio a mujeres en edad fértil, si
    -aplican métodos anticonceptivos adecuados desde 30 días antes de la visita del día 1 y están de acuerdo en mantenerlos durante todo el período de tratamiento y hasta 2 meses después de completar la serie de vacunación
    E.4Principal exclusion criteria
    Medical conditions
    •Any primary kidney disease with a high incidence of recurrent primary kidney disease within the allograft
    •Evidence of recurrent primary kidney disease within the current allograft
    •Previous allograft loss secondary to recurrent primary kidney disease
    •History of more than one organ transplanted
    •Subjects with an episode of acute allograft rejection over the six months (180 days) prior to enrolment or receipt of treatment for rejection during the six months (180 days) prior to enrolment
    •Panel Reactive Antibodies (PRA) calculated PRA (cPRA) or Calculated Reaction Frequency (cRF) score that is unknown at the time of transplant
    •VZV serostatus unknown prior to transplant
    •Subjects with advanced chronic kidney disease
    •Evidence of significant proteinuria
    •Subjects without multiple dialysis options in the event acute or chronic dialysis needed.
    •History of unstable or progressive neurological disorder.
    •Subjects <= 5 years of age with a history of one or more simple or complex febrile seizures
    •Subjects > 5 years with history of one or more complex febrile seizures
    •Occurrence of a varicella or HZ episode by clinical history within the 6 months (180 days) preceding Visit Day 1
    •Any autoimmune disease, with the following exceptions which do not constitute an exclusion criterion:
    -IgA nephropathy
    -Rapidly progressive glomerulonephritis
    -Membranous glomerulonephritis
    -Idiopathic Type I membranoproliferative glomerulonephritis
    -Diabetes mellitus (type 1 and 2) with diabetic nephropathy
    •Confirmed or suspected Human Immunodeficiency Virus or primary immunodeficiency disease
    •Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study
    •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine
    •Any condition which, in the judgement of the investigator would make intramuscular injection unsafe

    Prior/Concomitant therapy
    •Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before Visit Day 1 (Day -29 to Day -1), or planned use during the study period. Subjects on treatment for rejection with ongoing treatment with T-cell depleting Ab or IL2R Ab
    •Use of anti-CD20 or other B-cell monoclonal antibody agents within 1 year of Visit Day 1 or planned administration during the duration of the study
    •Administration of blood products prior to 3 months (90 days) of enrolment or planned administration during the duration of the study
    •Administration of immunoglobulins prior to 6 months (180 days) of enrolment or planned administration of immunoglobulins during the duration of the study
    •Administration or planned administration of a vaccine in the period starting 30 days before Visit Day 1 up to Visit Month 2
    •Previous vaccination against HZ
    •Varicella vaccination within the 6 months (180 days) preceding Visit Day 1
    •Planned administration during the study of an HZ or varicella vaccine (including an investigational or non-registered vaccine) other than the study vaccine
    Prior/Concurrent clinical study experience
    •Concurrent or planned participation in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product
    -available locally through compassionate use programs,
    -submitted for and pending local/country registration,
    -approved and registered for use in other countries with well-documented Summary of Product Characteristics or Prescribing Information
    -The name of the active component(s) of these immunosuppressants must be provided in the concomitant medication listing

    Other exclusions
    •Child in care
    •Pregnant or lactating female
    •Female planning to become pregnant or planning to discontinue contraceptive precautions (if of childbearing potential) between one month (30 days) prior to Visit Day 1 through two months (60 days) after Visit Month 1.
    •Evidence or high suspicion, in the opinion of the investigator, of non-compliance or non-adherence to use of induction and/or maintenance immunosuppressive therapies.
    •Failure to fully complete the 7-day pre-vaccination diary card distributed at the Pre-vaccination visit
    -Completion must cover the 7 days immediately prior to randomisation (Visit Day 1)
    -Completion is defined as a minimum of 6 days completed
    -Subjects with less than 6 days completed may be offered a new date for Visit Day 1 and the opportunity to comply with the completion of the 7-day pre-vaccination diary card prior to the new planned Visit Day 1
    •Any study personnel or their immediate dependants, family, or household member
    •Cualquier enfermedad renal primaria con una incidencia alta de recidiva en el aloinjerto.
    •Evidencia de enfermedad renal primaria recidivante en el aloinjerto actual.
    •Pérdida previa del aloinjerto secundaria a enfermedad renal primaria recidivante.
    •Trasplante de más de un órgano
    •Sujetos con un episodio de rechazo agudo del aloinjerto durante los seis meses (180 días) anteriores al reclutamiento o o que haya recibido tratamiento por un rechazo durante los seis meses (180 días) anteriores al reclutamiento.
    •Puntuación PRA o cPRA o cRF desconocida en el momento del trasplante.
    •Estado serológico desconocido frente al VZV antes del trasplante.
    •Sujetos con enfermedad renal crónica (ERC) avanzada
    •Proteinuria significativa
    •Sujetos que carezcan de múltiples opciones de diálisis en el caso de que se necesite diálisis aguda o crónica.
    •Historia de trastornos neurológicos inestables o progresivos.
    •Sujetos de <= 5 años de edad con antecedentes de una o más convulsiones febriles simples o complejas.
    •Sujetos > 5 años con antecedentes de una o más convulsiones febriles complejas.
    •Episodio de varicela o HZ de acuerdo con la historia clínica en los 6 meses (180 días) anteriores a la visita del día 1.
    •Cualquier enfermedad autoinmune, con las siguientes excepciones que no constituyen un criterio de exclusión:
    -Nefropatía por IgA
    -Glomerulonefritis rápidamente progresiva
    -Glomerulonefritis membranosa
    -Glomerulonefritis membranoproliferativa (GNMP) idiopática de tipo I
    -Diabetes mellitus (tipo 1 y 2) con nefropatía diabética
    •Confirmación o sospecha de infección por VIH o de inmunodeficiencia primaria.
    •Cualquier estado clínico que, en opinión del investigador, pudiera suponer un riesgo para el sujeto si participara en el estudio.
    •Antecedentes de reacción o de hipersensibilidad que se puedan exacerbar por algún componente de la vacuna.
    •Cualquier afección que, a juicio del investigador, haga insegura la inyección intramuscular (i.m.).
    E.5 End points
    E.5.1Primary end point(s)
    1. Number of subjects from the interventional groups, with solicited local adverse events (AEs)
    2. Number of subjects from the interventional groups, with solicited general AEs
    3. Number of subjects from the control groups with solicited general symptoms
    4. Number of subjects from the control groups with solicited general symptoms
    5. Number of subjects from the interventional groups with unsolicited AEs after each vaccination
    6. Number of subjects from the control groups with unsolicited symptoms
    7. Number of subjects from the control groups with unsolicited symptoms
    8. Number of subjects with serious adverse events (SAEs), potential immune mediated diseases (pIMDs) and biopsy confirmed renal allograft rejection
    9. Number of subjects from the interventional groups with seizures
    10. Number of subjects from the non-interventional groups with seizures
    11. Number of subjects from the non-interventional groups with seizures
    12. Number of subjects from the interventional groups with generalized convulsive seizures
    13. Number of subjects from the non-interventional groups with generalized convulsive seizures
    14. Number of subjects from the non-interventional groups with generalized convulsive seizures
    15. Percentage of subjects with Anti-gE antibody concentrations in terms of Geometric Mean Concentrations (GMCs)
    1. Número de sujetos del grupo intervencional con acontecimientos adversos solicitados locales (AAs)
    2.Número de sujetos del grupo intervencional con acontecimientos adversos solicitados generales (AAs)
    3. Número de sujetos del grupo control cos síntomas solicitados generales
    4. Número de sujetos del grupo control cos síntomas solicitados generales
    5. Número de sujetos del grupo intervencional con acontecimientos adversos no solicitados después de cada vacunación
    6. Número de sujetos del grupo control cos síntomas no solicitados
    7. Número de sujetos del grupo control cos síntomas no solicitados
    8. Número de sujetos con acontecimientos adversos serios, potenciales enfermedades mediadas por inmunidad y con una biopsia que confirme el rechazo del trasplante renal
    9. Número de sujetos del grupo intervencional con convulsiones
    10. Número de sujetos del grupo no intervencional con convulsiones
    11. Número de sujetos del grupo no intervencional con convulsiones
    12. Número de sujetos del grupo intervencional con convulsiones generalizadas
    13. Número de sujetos del grupo no intervencional con convulsiones generalizadas
    14. Número de sujetos del grupo no intervencional con convulsiones generalizadas
    15. Porcentaje de sujetos que presentan concentraciones de anticuerpos anti-gE que se consideran relevantes (según GMCs)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Within 7 days after each vaccination
    2. Within 7 days after each vaccination
    3. Within 7 days after Visit Day 1
    4. Within 7 days after Visit Month 1
    5. Within 30 days after each vaccination
    6. Within 30 days after Visit Day 1
    7. Within 30 days after Visit Month 1
    8. From Visit Day 1 up to Visit Month 2
    9. Within 30 days after each vaccination
    10. Within 30 days after Visit Day 1
    11. Within 30 days after Visit Month 1
    12. Within 7 days after each vaccination
    13. Within 7 days after Visit Day 1
    14. Within 7 days after Visit Month 1
    15. At Month 2 (one-month post-dose 2)
    1. En los 7 días tras cada vacunación
    2. En los 7 días tras cada vacunación
    3. En los 7 días tras la visita del día 1
    4. En los 7 días tras la visita del mes 1
    5. En los 30 días tras cada vacunación
    6. En los 30 días tras la visita del día 1
    7. En los 30 días tras la visita del mes 1
    8. De la visita del día 1 hasta la visita del mes 2
    9. En los 30 días tras cada vacunación
    10.En los 30 días tras la visita del día 1
    11.En los 30 días tras la visita del mes 1
    12.En los 7 días tras cada vacunación
    13.En los 7 días tras la visita del día 1
    14. En los 7 días después de la visita del mes 1
    15. En mes 2 (1 mes después de dosis 2)
    E.5.2Secondary end point(s)
    1. Number of subjects with SAEs, pIMDs and biopsy confirmed renal allograft rejections from day 1 to month 13
    2. Occurrence of Herpes Zoster cases
    3. Number of subjects from the interventional pooled age group with solicited local AEs
    4. Number of subjects from the interventional pooled age group with solicited general AEs
    5. Number of subjects from the non-interventional pooled age group with solicited general symptoms
    6. Number of subjects from the interventional pooled age group with unsolicited AEs after each vaccination
    7. Number of subjects from the non-interventional pooled age group with unsolicited symptoms
    8. Number of subjects from the pooled age groups with any SAEs, pIMDs and biopsy confirmed renal allograft rejections
    9. Number of subjects from the pooled age groups with HZ
    10. Number of subjects from the interventional pooled age group with seizures
    11. Number of subjects from the non-interventional pooled age group with seizures
    12. Number of subjects from the interventional pooled age group with generalized convulsive seizures
    13. Number of subjects from the non-interventional pooled age group with generalized convulsive seizures
    14. Vaccine Response Rate (VRR) for Anti-glycoprotein (Anti-gE) antibody concentrations
    15. Median fold increase of anti-gE antibody concentrations
    16. Percentage of subjects with anti-gE antibody concentrations in terms of GMCs
    17. Percentage of subjects in the interventional pooled age group, with Anti-gE antibody concentrations in terms of GMCs
    1. Número de sujetos con AAG, pEMI y rechazo del aloinjerto renal confirmado por biopsia desde la visita del día 1 hasta la visita del mes 13
    2. Frecuencia de caso de HZ en sujetos
    3. Número de sujetos de la categoria etaria combinada intervencional con AAs locales
    4. Número de sujetos de la categoria etaria combinada intervencional con AAs generales
    5. Número de sujetos de la categoria etaria combinada no intervencional con síntomas solicitados generales
    6. Número de sujetos de la categoria etaria combinada intervencional con AAs no solicitados después de cada vacunación
    7. Número de sujetos de la categoria etaria combinada no intervencional con síntomas no solicitados
    8. Número de sujetos de la categoria etaria con AAG, pEMI y rechazo del aloinjerto renal confirmado por biopsia
    9. Número de sujetos de la categoria etaria con HZ
    10. Número de sujetos de la categoria etaria intervencional con convulsiones
    11.Número de sujetos de la categoria etaria no intervencional con convulsiones
    12. Número de sujetos de la categoria etaria intervencional con crisis convulsivas generalizadas
    13. Número de sujetos de la categoria etaria no intervencional con crisis convulsivas generalizadas
    14. TRV de la inmunogenicidad humoral en concentraciones de anticuerpos anti-gE
    15. Mediana de incremento de anticuerpos anti-gE
    16. Porcentaje de sujetos con concentraciones de anticuerpos anti-gE según las GMCs
    17. Porcentaje de sujetos en la categoría etaria combinada intervencional con concentraciones de anticuerpos anti-gE según las GMCs
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. From Visit Day 1 up to Visit Month 13
    2. From Visit Day 1 until Visit Month 13
    3. Within 7 days after each vaccination
    4. Within 7 days after each vaccination
    5. Within 7 days after Visit Day 1 and visit Month 1
    6. Within 30 days after each vaccination
    7. Within 30 days after Visit Day 1 and Visit Month 1
    8. From Visit Day 1 until Visit Month 2 and From Visit Day 1 until Visit Month 13
    9. From Visit Day 1 until Visit Month 13
    10. Within 30 days after each vaccination
    11. Within 30 days after Visit Day 1 and Visit Month 1
    12. Within 7 days after each vaccination
    13. Within 7 days after Visit Day 1 and Visit Month 1
    14. At Month 2 and Month 13
    15. At Month 2 and Month 13
    16. At Day 1 (pre-vaccination) and Month 13
    17. At Day 1, Month 2 and Month 13
    1. De visita día 1 hasta visita mes 13
    2. De visita día 1 hasta visita del mes 13
    3. En los 7 días tras cada vacunación
    4. En los 7 días tras cada vacunación
    5. En los 7 días tras la visita de día 1 y visita de mes 1
    6. En los 30 días tras cada vacunación
    7. En los 30 días tras la visita de día 1 y visita de mes 1
    8. Desde la visita del día 1 hasta la visita del mes 2 y desde la visita del día 1 hasta la visita del mes 13
    9. Desde la visita del día 1 hasta la visita del mes 13
    10. En los 30 días tras cada vacunación
    11. En los 30 días tras la visita de día 1 y visita de mes 1
    12. En los 7 días tras cada vacunación
    13. En los 7 días tras la visita de día 1 y visita de mes 1
    14. Mes 2 y mes 13
    15. Mes 2 y mes 13
    16. Día 1 (prevacunación) y mes 13
    17. Día 1, mes 2 y mes 13
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    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
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    No vacunación del estudio, tratamiento según el estandar local, incluyendo vacunación rutinaria
    No study vaccination, treatment according to local standard of care, including routine vaccination
    E.8.2.4Number of treatment arms in the trial4
    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 concerned6
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 testing results released of samples collected at Visit Month 13
    Resultados de las muestras recogidas hasta visita del mes 13
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    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: 184
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 92
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 92
    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 No
    F.3.2Patients Yes
    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
    Subjects under age incapable of giving consent personally
    Sujetos incapaces de otorgar su consentimiento debido al rango de edad
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 184
    F.4.2.2In the whole clinical trial 184
    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 Decision2019-06-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-06
    P. End of Trial
    P.End of Trial StatusOngoing
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