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    Summary
    EudraCT Number:2019-000560-22
    Sponsor's Protocol Code Number:MT-12
    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:2019-08-09
    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 number2019-000560-22
    A.3Full title of the trial
    A one-year placebo-controlled phase III trial evaluating the efficacy and safety of the house dust mite (HDM) SLIT-tablet in children (5-11 years of
    age) with HDM allergic rhinitis/rhinoconjunctivitis with or without asthma
    Ensayo de fase III controlado con placebo, de un año de duración, para evaluar la eficacia y seguridad de la inmunoterapia sublingual en comprimidos frente a ácaros del polvo doméstico en niños (de 5-11 años de edad) con rinitis/rinoconjuntivitis alérgica inducida por ácaros del polvo doméstico, con o sin asma.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial studying the effect of the house dust mite tablet on children with allergic rhinitis/rhinoconjunctivitis
    Ensayo clínico que estudia el efecto de los comprimidos frente a ácaros del polvo doméstico en niños con rinitis / rinoconjuntivitis alérgica
    A.4.1Sponsor's protocol code numberMT-12
    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 SponsorALK-Abelló A/S
    B.1.3.4CountryDenmark
    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 supportALK-Abelló A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPharm-Olam International (Spain) S.L.U
    B.5.2Functional name of contact pointRegulatory Department
    B.5.3 Address:
    B.5.3.1Street AddressC/Antracita, 7 Planta 1 A Nave 6
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28045
    B.5.3.4CountrySpain
    B.5.4Telephone number3491145 91 10
    B.5.5Fax number3491434 27 73
    B.5.6E-mailregulatory.spain@pharm-olam.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 Yes
    D.2.1.1.1Trade name ACARIZAX
    D.2.1.1.2Name of the Marketing Authorisation holderALK-Abello A/S
    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 nameHDM SLIT-tablet
    D.3.4Pharmaceutical form Oral lyophilisate
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSublingual use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDERMATOPHAGOIDES PTERONYSSINUS EXTRACT
    D.3.9.3Other descriptive nameDERMATOPHAGOIDES PTERONYSSINUS EXTRACT
    D.3.9.4EV Substance CodeSUB84531
    D.3.10 Strength
    D.3.10.1Concentration unit SQU Standardised Quality Unit(s) (Deprecated)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDERMATOPHAGOIDES FARINAE EXTRACT
    D.3.9.3Other descriptive nameDERMATOPHAGOIDES FARINAE EXTRACT
    D.3.9.4EV Substance CodeSUB84530
    D.3.10 Strength
    D.3.10.1Concentration unit SQU Standardised Quality Unit(s) (Deprecated)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral lyophilisate
    D.8.4Route of administration of the placeboSublingual use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Allergic rhinitis/rhinoconjunctivitis induced by house dust mites
    Rinitis / rinoconjuntivitis alérgica inducida por ácaros del polvo doméstico
    E.1.1.1Medical condition in easily understood language
    House dust mite allergy
    Alergia a los ácaros del polvo doméstico
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10020419
    E.1.2Term House dust mite allergy
    E.1.2System Organ Class 100000004870
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to demonstrate the efficacy of the HDM SLIT-tablet compared to placebo in the treatment of HDM allergic rhinitis (AR)
    in children (5-11 years of age) based on total combined rhinitis symptoms and medication use (TCRS) during the primary efficacy assessment period.
    El objetivo principal es demostrar la eficacia del comprimido de inmunoterapia sublingual (ITSL) frente a ácaros del polvo doméstico (APD) en comparación con un placebo en el tratamiento de la rinitis alérgica (RA) inducida por APD en niños (de 5 a 11 años de edad) según la puntuación combinada total de síntomas de rinitis y consumo de medicamentos (PCTR) durante el período principal de evaluación de la eficacia.
    E.2.2Secondary objectives of the trial
    The key secondary objectives are to demonstrate the efficacy of the HDM SLIT-tablet compared to placebo during the primary efficacy assessment
    period based on:
    1. Rhinitis symptoms (based on DSS)
    2. Rhinitis medication use (based on DMS)
    3. Combined rhinoconjunctivitis symptoms and medication use (based on TCS)

    The additional secondary objectives are to evaluate the HDM SLIT-tablet compared to placebo during the primary efficacy assessment period with
    respect to:
    - Safety and tolerability
    - Rhinoconjunctivitis symptoms
    - Rhinoconjunctivitis medication use
    - Rhinoconjunctivitis quality of life (QoL)
    - Asthma symptoms and medication use
    -Changes in immunological parameters
    Los objetivos secundarios clave son demostrar la eficacia del comprimido de ITSL frente a APD en comparación con un placebo durante el período principal de evaluación de la eficacia, según los siguientes parámetros:
    1. Síntomas de rinitis (según la puntuación diaria de la presencia de síntomas [PDS])
    2. Consumo de medicamentos para la rinitis (según la puntuación diaria del consumo de medicamentos [PDM])
    3. Puntuación combinada de los síntomas de rinoconjuntivitis y consumo de medicamentos (según la puntuación combinada total [PCT])

    Los demás objetivos secundarios consisten en la evaluación del comprimido de ITSL frente a APD en comparación con un placebo durante el período principal de evaluación de la eficacia, en cuanto a:
    • Seguridad y tolerabilidad
    • Síntomas de rinoconjuntivitis
    • Consumo de medicamentos para la rinoconjuntivitis
    • Calidad de vida (CdV) con rinoconjuntivitis
    • Síntomas de asma y consumo de medicamentos
    • Variaciones en parámetros inmunológicos
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female, aged 5-11 years old at randomisation, of any race/ethnicity and weighing 15 kg or more on the day of screening
    - A clinical history of AR/C when exposed to HDM (diagnosed by a physician) of 1 year duration or more (with or without asthma) and with
    allergic rhinitis symptoms despite having received allergy pharmacotherapy during the previous year prior to the screening visit
    - Have a rhinitis DSS of at least 6, or a score of at least 5 with one symptom being severe, on at least 8 of the last 14 days of the baseline period
    - Use symptomatic medication for treatment of HDM allergic rhinitis during at least 8 of the last 14 days of the baseline period
    - Presence of one or more of the Allergic Rhinitis Impact on Asthma (ARIA) quality of life items due to HDM AR/C during the last 14 days of
    the baseline period
    - Positive skin prick test (SPT) to D. pteronyssinus or D. farinae at screening
    - Positive D. pteronyssinus or D. farinae specific IgE (defined as ≥class 3, ≥3.5 kU/l) at screening
    - Lung function measured by FEV1 ≥ 70% of predicted value or according to local requirements while on subject's usual asthma
    medication following at least a 6-hour washout of SABA at screening, baseline visit, and at randomisation
    - Niño o niña de cualquier raza o etnia y cuyo peso sea de 15 kg o más el día de la selección
    - Antecedentes clínicos de RA/C ante la exposición a APD (diagnóstico realizado por un médico) de 1 año o más de duración (con o sin asma) y con síntomas de rinitis alérgica a pesar de haber recibido tratamiento farmacológico para la alergia en el transcurso del año previo a la visita de selección.
    - Presencia de como mínimo una PDS de rinitis de 6, o una puntuación de por lo menos 5 con un síntoma que sea intenso, durante por lo menos 8 días de los últimos 14 días del período basal
    - En tratamiento sintomático para la rinitis alérgica por APD durante por lo menos 8 días de los últimos 14 días del período basal
    - Presencia de uno o más de los ítems de calidad de vida de la guía Impacto de la rinitis alérgica en el asma (ARIA) debido a la RA/C por APD durante los últimos 14 días del período basal
    - Resultado positivo de la prueba intraepidérmica (PIE) para D. pteronyssinus o D. farinae en la selección
    - Resultado positivo de la IgE específica frente a D. pteronyssinus o D. farinae (definido como ≥ clase 3, ≥ 3,5 kU/l) en la selección
    - Función pulmonar determinada mediante un VEM1 ≥ 70% del valor previsto , o según los requisitos nacionales, mientras el paciente recibe su medicación habitual para el asma después de un período de lavado de ABCD de por lo menos 6 horas en la selección, la visita basal y la aleatorización
    E.4Principal exclusion criteria
    -A clinically relevant history of symptomatic perennial AR/C caused by a perennial allergen source such as animal hair and dander and/or mould,
    or symptomatic seasonal AR/C and/or asthma caused by an allergen to which the subject is exposed in the baseline and/or efficacy assessment
    period.
    - SLIT or SCIT treatment reaching the maintenance dose, with D. pteronyssinus or D. farinae for more than 1 month within the last 5
    years. In addition, any SLIT or SCIT treatment with D. pteronyssinus or D. farinae within the previous 12 months
    - Treatment with medications with potential impact on efficacy endpoints (e.g. treatment with anti-IgE drugs within 130 days/5 halflives
    of the drug (which ever longest) or treatment with antidepressant or antipsychotic medications with antihistaminergic effect)
    - Asthma requiring daily use of more than 400 mcg budesonide or equivalent at screening or any clinical deterioration of asthma that
    resulted in emergency treatment, hospitalisation or treatment with systemic corticosteroids within 3 months prior to randomisation
    - A history of chronic urticaria (> 6 weeks) and/or chronic angioedema (> 6 weeks) within the last 2 years prior to screening that in the opinion
    of the investigator may constitute an increased safety concern.
    - A relevant history of systemic allergic reaction e.g. anaphylaxis with cardiorespiratory symptoms, generalised urticaria or severe facial
    angioedema that in the opinion of the investigator may constitute an increased safety concern
    - Severe chronic oral inflammation
    - A diagnosis or history of eosinophilic oesophagitis
    - Active or poorly controlled autoimmune diseases, immune defects, immunodeficiencies, immunosuppression or malignant neoplastic
    diseases with current disease relevance or any immunosuppressive treatment within 3 months prior to screening
    - Known history of allergy, hypersensitivity or intolerance to any of the excipients or active substances of the IMP (except for D. pteronyssinus
    and/or D. farinae) or to any excipient of the rescue medication provided in this trial
    - May be at greater risk of developing severe adverse reactions after adrenaline/epinephrine administration
    - Antecedentes clínicos importantes de RA/C perenne sintomática provocada por una fuente permanente de alérgenos, como son el pelo y la caspa de animales o los hongos, a los cuales el paciente está expuesto, rinoconjuntivitis alérgica estacional sintomática y/o asma provocados por un alérgeno al cual el paciente está expuesto y que posiblemente podría superponerse con el período basal y/o el período de evaluación de la eficacia
    - Tratamiento con ITSL o ITSC con D. pteronyssinus o D. farinae durante más de 1 mes en los últimos 5 años. Asimismo, cualquier tratamiento con ITSL con D. pteronyssinus o D. farinae en los 12 meses anteriores
    - Tratamiento con medicamentos que podrían afectar a los criterios de evaluación de la eficacia (por ej., tratamiento con fármacos anti-IgE en un período de 130 días/5 semividas del fármaco [el intervalo más largo]) o tratamiento con antidepresivos o antipsicóticos con efecto antihistaminérgico)
    - Asma que requiere la administración diaria de más de 400 µg de budesonida o equivalente en el momento de la selección o todo empeoramiento clínico del asma que haya dado lugar a un tratamiento de emergencia, una hospitalización o un tratamiento con corticoesteroides sistémicos en los 3 meses previos a la aleatorización
    - Antecedentes de urticaria crónica (> 6 semanas) y/o angioedema crónico (> 6 semanas) en los últimos 2 años previos a la selección que, a juicio del investigador, podrían representar un riesgo aumentado para la seguridad del paciente
    - Antecedentes importantes de reacción alérgica sistémica, como por ejemplo, anafilaxia con síntomas cardiorrespiratorios, urticaria generalizada o angioedema facial grave que, a juico del investigador, podrían representar un riesgo aumentado para la seguridad del paciente
    - Inflamación oral crónica intensa
    - Diagnóstico o antecedentes de esofagitis eosinofílica
    - Enfermedades autoinmunitarias activas o no controladas adecuadamente, anomalías inmunitarias, inmunodeficiencias, inmunosupresión o enfermedades neoplásicas malignas relevantes para la enfermedad actual o cualquier tratamiento con inmunosupresores en los 3 meses anteriores a la selección
    - Antecedentes conocidos de alergia, hipersensibilidad o intolerancia a alguno de los excipientes o principios activos del IMP (excepto D. pteronyssinus y/o D. farinae) o a algún excipiente de la medicación de rescate proporcionada en el presente ensayo
    - Padecer alto riesdo de presentar reacciones adversas graves después de la administración de adrenalina/epinefrina
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy endpoint during the efficacy assessment period is:
    The average daily TCRS

    The daily TCRS is the sum of the rhinitis daily symptoms score (DSS) and the rhinitis daily medication score (DMS).
    El criterio de valoración principal de la eficacia durante el período principal de evaluación de la eficacia es: La PCTR diaria promedio.

    La PCTR diaria es la suma de la PDS de rinitis y de la PDM para rinitis.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During the efficacy assessment period which is the last 8 weeks (period 4) of the approximately 12 months IMP treatment.
    Durante el período de evaluación de la eficacia que son las últimas 8 semanas (período 4) de los aproximadamente 12 meses de tratamiento con IMP.
    E.5.2Secondary end point(s)
    Key secondary efficacy endpoints during the efficacy assessment period are:
    - The average rhinitis DSS
    - The average rhinitis DMS
    - The average total combined score (TCS)
    The daily TCS is the sum of the rhinoconjunctivitis DSS (rhinitis DSS + conjunctivitis DSS) and the rhinoconjunctivitis DMS (rhinitis DMS +
    conjunctivitis DMS).
    The safety and tolerability endpoints are:
    - Treatment-emergent adverse events (TEAEs), solicited AEs, IMP related AEs, treatment-emergent serious adverse events (SAEs), event
    of special interest (ESI), TEAEs leading to discontinuation, time to discontinuation due to TEAEs
    - Vital signs, physical examination, FEV1 and clinical laboratory values during treatment and at the final visit (visit 7)
    Additional secondary efficacy endpoints during the efficacy assessment period are:
    - Average rhinoconjunctivitis DSS
    - Average rhinoconjunctivitis DMS
    - Paediatric rhinoconjunctivitis quality of life questionnaire (PRQLQ)
    - Average asthma DSS
    - Average daily use of short-acting β2-agonist (SABA)
    - Rhinitis mild days
    - Rhinitis exacerbation days (days with a rhinitis DSS of 6 or of 5 with
    one individual symptom scored 3 (symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping))
    - Average rhinitis combined symptom and medication score (CSMS)
    The immunologic endpoints are:
    - Change from baseline in specific IgE and IgG4 to D. pteronyssinus and D. farina, change in baseline for HDM IgE-Blocking factor (IgE-BF) and
    change in baseline for total IgE measured at end of trial (visit 7)
    Los criterios de valoración secundarios clave durante el período de evaluación de la eficacia son:
    •La PDS de rinitis promedio
    •La PDM para rinitis promedio
    •La PCT promedio
    La PCT diaria es la suma de la PDS de rinoconjuntivitis (PDS de rinitis + PDS de conjuntivitis) y de la PDM para rinoconjuntivitis (PDM para rinitis + PDM para conjuntivitis).
    Los criterios de valoración de la seguridad y tolerabilidad son:
    •Acontecimientos adversos surgidos durante el tratamiento (AAST), AA declarados, AA asociados al IMP, acontecimientos adversos graves (AAG) surgidos durante el tratamiento, acontecimientos adversos de especial interés (AAEI), AAST que den lugar a la retirada del ensayo, tiempo transcurrido hasta la retirada debido a AAST
    •Constantes vitales, exploración física, VEM1 y resultados de pruebas analíticas durante el tratamiento y en la visita final (visita 7)
    Los demás criterios secundarios de valoración de la eficacia durante el período de evaluación de la eficacia son:
    •PDS de rinoconjuntivitis promedio
    •PDM para rinoconjuntivitis promedio
    •Cuestionario de calidad de vida en niños con rinoconjuntivitis (PRQLQ, paediatric rhinoconjunctivitis quality of life questionnaire)
    •PDS de asma promedio
    •Promedio del consumo diario de ABCD
    •Número de días con rinitis leve
    •Número de días con exacerbación de la rinitis (días con una PDS de rinitis de 6, o de 5 con un síntoma individual con una puntuación de 3 [síntoma que es difícil de tolerar, que interfiere con las actividades de la vida diaria y/o con el sueño)
    •Promedio de la puntuación combinada de la presencia de síntomas y consumo de medicamentos (PCSM) para la rinitis
    Los criterios de valoración inmunológicos son:
    •Variación respecto a los valores iniciales en la IgE y la IgG4 específicas frente a D. pteronyssinus y D. farinae, variación respecto al valor inicial en el factor bloqueante de la IgE (FB-IgE) frente a APD y variación respecto al valor inicial en la IgE total, determinados al final del ensayo (visita 7)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints will be evaluated during the efficacy asessment period, as specified for applicable endpoints, or througout the trial (safety and tolerability as well as immunologic endpoints).
    Los criterios secundarios de valoración se evaluarán durante el período de evaluación de la eficacia, según se especifique para los criterios de valoración aplicables, o durante el ensayo (seguridad y tolerabilidad, así como los criterios de valoración inmunológicos).
    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 Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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 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 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA46
    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
    Russian Federation
    Ukraine
    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
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    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: 1370
    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: 1370
    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 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 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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 466
    F.4.2.2In the whole clinical trial 1370
    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 Decision2019-08-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-24
    P. End of Trial
    P.End of Trial StatusOngoing
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