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    Summary
    EudraCT Number:2019-001186-33
    Sponsor's Protocol Code Number:AIV_FLU_2019_01_VIGIRA_JDD
    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:2019-06-11
    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 number2019-001186-33
    A.3Full title of the trial
    Clinical trial, phase IV, randomized, double-blind, controlled, in children aged 12 to 35 months, of the vaccine against seasonal influenza to estimate efficacy against influenza and other respiratory infections
    Ensayo clínico de fase IV, aleatorizado, doble ciego, controlado, en niños de 12 a 35 meses, de la vacuna contra la gripe estacional para estimar la eficacia frente a la gripe y frente a otras infecciones respiratorias
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial in children from 12 to 35 months of the flu vaccine to estimate efficacy against influenza and other respiratory infections
    Ensayo clínico en niños de 12 a 35 meses de la vacuna contra la gripe para estimar la eficacia frente a la gripe y frente a otras infecciones respiratorias
    A.3.2Name or abbreviated title of the trial where available
    VIGIRA
    VIGIRA
    A.4.1Sponsor's protocol code numberAIV_FLU_2019_01_VIGIRA_JDD
    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 SponsorFISABIO
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportFondo de Investigación en Salud - Instituto de Salud Carlos III
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFISABIO
    B.5.2Functional name of contact pointAIV
    B.5.3 Address:
    B.5.3.1Street AddressAv. Cataluña, 21
    B.5.3.2Town/ cityValencia
    B.5.3.3Post code46020
    B.5.3.4CountrySpain
    B.5.4Telephone number+34961925968
    B.5.5Fax number+34961925938
    B.5.6E-mailvacunas_fisabio@gva.es
    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 Yes
    D.2.1.1.1Trade name Fluarix tetra
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameFluarix Tetra
    D.3.4Pharmaceutical form 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 INNA/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180)
    D.3.9.3Other descriptive nameA/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180)
    D.3.9.4EV Substance CodeSUB187226
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNA/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, NIB-104)
    D.3.9.3Other descriptive nameA/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, NIB-104)
    D.3.9.4EV Substance CodeSUB191971
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNB/COLORADO/06/2017-LIKE STRAIN (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A)
    D.3.9.3Other descriptive nameB/COLORADO/06/2017-LIKE STRAIN (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A)
    D.3.9.4EV Substance CodeSUB191972
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNB/PHUKET/3073/2013-LIKE STRAIN (B/PHUKET/3073/2013, WILD TYPE)
    D.3.9.3Other descriptive nameB/PHUKET/3073/2013-LIKE STRAIN (B/PHUKET/3073/2013, WILD TYPE)
    D.3.9.4EV Substance CodeSUB178474
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Havrix 720
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.4Pharmaceutical form 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 INNHEPATITIS A VIRUS ANTIGEN (INACTIVATED)
    D.3.9.3Other descriptive nameHEPATITIS A VIRUS ANTIGEN (INACTIVATED)
    D.3.9.4EV Substance CodeSUB38555
    D.3.10 Strength
    D.3.10.1Concentration unit ELISA unit enzyme-linked immunosorbent assay unit
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number720
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Flu and acute respiratory infections
    Gripe e infecciones respiratorias agudas
    E.1.1.1Medical condition in easily understood language
    Flu and respiratory infeccions
    Gripe e infecciones respiratorias
    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 estimate the effectiveness of the inactivated flu vaccine with the number of episodes of acute respiratory infections, its severity and its complications in children with risk.
    Estimar la eficacia de la VIG frente al número de episodios de IRA, su gravedad y sus complicaciones en niños con riesgo.
    E.2.2Secondary objectives of the trial
    To estimate the effectiveness of the inactivated flu vaccine against the number of episodes of acute respiratory infections, its severity and its complications in children at risk by sex.
    To estimate the effectiveness of the inactivated flu vaccine against the number of flu infections confirmed by laboratory.
    To estimate the effectiveness of the inactivated flu vaccine against the number of episodes of acute respiratory infections with non-influenza virus isolation.
    To estimate the effectiveness of the inactivated flu vaccine against the number of episodes of acute respiratory infections with detection of respiratory viruses (influenza and not influenza).
    To analyze the consumption of resources in vaccinated and unvaccinated children with acute respiratory infections.
    Estimar la eficacia de la VIG frente al número de episodios de IRA, su gravedad y sus complicaciones en niños con riesgo por sexo.
    Estimar la eficacia de la VIG frente al número gripes confirmadas por laboratorio.
    Estimar la eficacia de la VIG frente al número de episodios de IRA con aislamiento de virus no gripe.
    Estimar la eficacia de la VIG frente al número de episodios de IRA con detección de virus respiratorios (gripe y no gripe).
    Analizar el consumo de recursos por cuadros de IRA en niños vacunados y no vacunados.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    To compare the understanding of traditional informed consent against an informed consent following the iConsent guidelines, as well as its quality as an information document.
    Comparar la comprensión del CI tradicional frente a un CI elaborado siguiendo las guías iConsent, así como su calidad como documento de información.
    E.3Principal inclusion criteria
    1. Subjects of both sexes who are between 12 to 35 months of age (both inclusive) with a history of recurrent or severe ARI defined as:
    a. three or more acute respiratory infections diagnosed in primary care (rhinitis, acute otitis media, pharyngitis, bronchitis, bronchiolitis or pneumonia) in the previous 6 months or four or more in the last 12 months; or
    b. a recurrent acute respiratory infection referral to the emergency department or the otorhinolaryngology specialist in the last 12 months; or
    c. an hospitalization by acute respiratory infection in the last 12 months.
    2. Informed consent of the parents or legal representatives of the subject.
    3. Subject and parent or other legally authorized representative, can and are willing to attend scheduled visits and accept all trial procedures.
    4. Willingness to use the mobile tracking application while the participation in the study lasts.
    1. Sujetos de ambos sexos que tengan entre 12 a 35 meses de edad (ambos inclusive) con antecedentes de IRA recurrente o grave definida como:
    a. tres o más IRA diagnosticadas en AP (rinitis, OMA, faringitis, bronquitis, bronquiolitis o neumonía) en los 6 meses previos o cuatro o más en los últimos 12 meses; o
    b. una derivación de IRA recurrente a urgencias o al especialista en otorrinolaringología en los últimos 12 meses; o
    c. una hospitalización por IRA en los últimos 12 meses.
    2. Consentimiento informado por escrito de los padres o representantes legales del sujeto.
    3. Sujeto y progenitor u otro representante legalmente autorizado, pueden y están dispuestos a asistir a las visitas programadas y aceptar todos los procedimientos del ensayo.
    4. Disposición a utilizar la aplicación móvil de seguimiento mientras dure la participación en el estudio.
    E.4Principal exclusion criteria
    1. Child in foster care, without legal tutor.
    2. Planned administration of any influenza vaccine (other than the study vaccine) during the entire study period, according to the official immunization schedule.
    3. Anaphylaxis known to the active ingredients or to any of the excipients included in the influenza vaccine data sheet or to any component that may be present in trace amounts, such as egg (ovalbumin, etc.).
    4. Anaphylaxis known to the active ingredients or to any of the excipients included in the hepatitis A vaccine data sheet.
    5. Any immunological disorder or medical condition that at the discretion of the pediatrician contraindicates vaccination against influenza or hepatitis A.
    6. Any treatment with chronic immunosuppressants (defined as more than 14 days) or other immunological treatment in the three months prior to the first dose of the vaccine or during the study. Topical use of corticosteroids (for example, cream, drops or aerosols), within the dose indicated on the product label, is allowed.
    7. Administration of immunoglobulins and / or any blood product (transfusion) within 3 months before the first dose of the study vaccine or planned administration during the study period.
    8. Have received any influenza vaccine or have been diagnosed with influenza in the same season (confirmed by laboratory diagnostic tests or rapid influenza).
    9. Have been previously vaccinated against hepatitis A.
    10. Have a fever and / or an acute illness or infection on the day of vaccination, defining fever as an axillary temperature ≥38.0°C. Immunization will be postponed until fever disappears.
    11. Planned surgery that requires a general anesthetic or planned surgery that requires hospitalization for at least 24 hours during the entire study period.
    12. Have participated in the first year of this study.
    13. Do not authorize the laboratory results to be recorded in the clinical record.
    1. Niño en acogida, sin tutor legal.
    2. Administración planificada de cualquier vacuna antigripal (que no sea la vacuna del estudio) durante todo el período de estudio, según el calendario oficial de vacunación.
    3. Anafilaxia conocida a los principios activos o a alguno de los excipientes incluidos en la ficha técnica de la vacuna de la gripe o a cualquier componente que pueda estar presente en cantidad de traza, tales como huevo (ovoalbúmina, etc.).
    4. Anafilaxia conocida a los principios activos o a alguno de los excipientes incluidos en la ficha técnica de la vacuna de la hepatitis A.
    5. Cualquier trastorno inmunológico o condición médica que a criterio del pediatra contraindique la vacunación contra la gripe o la hepatitis A.
    6. Cualquier tratamiento con inmunosupresores crónico (definido como más de 14 días) u otro tratamiento inmunológico en los tres meses anteriores a la primera dosis de la vacuna o durante el estudio. El uso tópico de corticosteroides (por ejemplo, crema, gotas o aerosoles), dentro de la dosis indicada en la etiqueta del producto, está permitido.
    7. Administración de inmunoglobulinas y/o de cualquier producto sanguíneo (transfusión) dentro de los 3 meses antes de la primera dosis de la vacuna del estudio o la administración planificada durante el período de estudio.
    8. Haber recibido alguna vacuna antigripal o que hayan sido diagnosticados de gripe en la misma temporada (confirmado por pruebas de diagnóstico de laboratorio o de influenza rápida).
    9. Haber sido vacunados previamente frente a la hepatitis A.
    10. Tener fiebre y /o una enfermedad o infección aguda el día de la vacunación, definiendo fiebre como una temperatura axilar ≥38,0°C.
    11. Cirugía planificada que requiera un anestésico general o cirugía planificada que requiera hospitalización durante al menos 24 horas durante todo el período de estudio.
    12. Haber participado en el primer año de este estudio.
    13. No autorizar que los resultados de laboratorio sean registrados en la historia clínica.
    E.5 End points
    E.5.1Primary end point(s)
    To estimate the efficacy of the influenza vaccine against the number of episodes of acute respiratory infection, its severity and its complications in children at risk. These are chosen as measures of net health effects and to analyze whether the vaccine causes viral interference.
    Estimar la eficacia de la vacuna contra la influenza contra el número de episodios de infección respiratoria aguda, su gravedad y sus complicaciones en niños en riesgo. Estos se eligen como medidas de los efectos netos para la salud y para analizar si la vacuna causa interferencia viral.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After each flu season (2020 and 2021), for two consecutive seasons.
    Después de cada temporada gripal (2020 y 2021), durante dos temporadas consecutivas.
    E.5.2Secondary end point(s)
    To estimate the effectiveness of the inactivated flu vaccine against the number of episodes of acute respiratory infections, its severity and its complications in children at risk by sex.
    To estimate the effectiveness of the inactivated flu vaccine against the number of flu infections confirmed by laboratory.
    To estimate the effectiveness of the inactivated flu vaccine against the number of episodes of acute respiratory infections with non-influenza virus isolation.
    To estimate the effectiveness of the inactivated flu vaccine against the number of episodes of acute respiratory infections with detection of respiratory viruses (influenza and not influenza).
    To analyze the consumption of resources in vaccinated and unvaccinated children with acute respiratory infections.
    Estimar la eficacia de la VIG frente al número de episodios de IRA, su gravedad y sus complicaciones en niños con riesgo por sexo.
    Estimar la eficacia de la VIG frente al número gripes confirmadas por laboratorio.
    Estimar la eficacia de la VIG frente al número de episodios de IRA con aislamiento de virus no gripe.
    Estimar la eficacia de la VIG frente al número de episodios de IRA con detección de virus respiratorios (gripe y no gripe).
    Analizar el consumo de recursos por cuadros de IRA en niños vacunados y no vacunados.
    E.5.2.1Timepoint(s) of evaluation of this end point
    September 2021
    Septiembre de 2021
    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 No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Havrix 720
    Havrix 720
    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 concerned12
    E.8.5The trial involves multiple Member States No
    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 No
    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
    September 2021
    Septiembre de 2021
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 400
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 400
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 400
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers 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 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
    The study is about children (12-35 months). The consent will be giving by the parents or legal guardians.
    El estudio trata sobre niños (12-35 meses). El consentimiento será otorgado por los padres o tutores legales.
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Children (12-35 months)
    Niños (12-35 meses)
    F.4 Planned number of subjects to be included
    F.4.1In the member state400
    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)
    Those patients who, once the blind has been opened, have been vaccinated with the hepatitis A vaccine, will have an additional dose to complete this regimen in a period established between 6 and 12 months after the last dose.
    Aquellos pacientes que, una vez abierto el ciego, hayan sido vacunados con la vacuna contra la hepatitis A, tendrán una dosis adicional para completar esta pauta en un periodo establecido entre los 6 y 12 meses después de la última dosis.
    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 Decision2019-09-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-25
    P. End of Trial
    P.End of Trial StatusOngoing
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