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    Summary
    EudraCT Number:2021-000104-38
    Sponsor's Protocol Code Number:MEQ00073
    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:2021-09-01
    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 number2021-000104-38
    A.3Full title of the trial
    A Phase IIIb, Open-label, Multi-center Study to Evaluate the Immunogenicity and Safety of a Booster Dose and Describe the Immune Persistence of the Priming Dose of MenACYW Conjugate Vaccine in Children in the European Union who had been Vaccinated 5 Years Earlier as Toddlers with MenACYW Conjugate Vaccine as Part of the MET51 Study
    Un estudio de fase IIIb, multicéntrico, abierto, para evaluar la inmunogenia y la seguridad de una dosis de refuerzo y describir la persistencia inmunitaria de la dosis de primovacunación de la vacuna conjugada MenACYW en niños de la Unión Europea que habían sido vacunados 5 años antes, cuando eran niños pequeños, con la vacuna conjugada MenACYW como parte del estudio MET51.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study on an Investigational Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Administered as a Booster Dose in Children Vaccinated 5 Years Earlier as Toddlers
    Estudio sobre una vacuna conjugada antimeningocócica tetravalente en investigación (vacuna conjugada MenACYW) administrada como dosis de refuerzo en niños vacunados 5 años antes cuando eran niños pequeños.
    A.4.1Sponsor's protocol code numberMEQ00073
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1255-4941
    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 SponsorSanofi Pasteur
    B.1.3.4CountryFrance
    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 supportSanofi Pasteur
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi-Aventis, S.A
    B.5.2Functional name of contact pointUnidad de Estudios Clínicos
    B.5.3 Address:
    B.5.3.1Street AddressC/ Josep Pla 2, 4ª planta
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08019
    B.5.3.4CountrySpain
    B.5.4Telephone number+3493485 94 00
    B.5.6E-mailes-unidadestudiosclinicos@sanofi.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 MenQuadfi - TM
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pasteur
    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 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 INNNeisseria Meningitidis Serogroup A Polysaccharide Conjugated to Tetanus Toxoid Carrier Protein
    D.3.9.3Other descriptive nameNEISSERIA MENINGITIDIS GROUP A POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
    D.3.9.4EV Substance CodeSUB36479
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNeisseria Meningitidis Serogroup C Polysaccharide Conjugated to Tetanus Toxoid Carrier Protein
    D.3.9.3Other descriptive nameNEISSERIA MENINGITIDIS SEROGROUP C POLYSACCHARIDE (PSC) CONJUGATED TO TETANUS TOXOID (TT)
    D.3.9.4EV Substance CodeSUB31471
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNeisseria Meningitidis Serogroup Y Polysaccharide Conjugated to Tetanus Toxoid Carrier Protein
    D.3.9.3Other descriptive nameNEISSERIA MENINGITIDIS GROUP Y POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
    D.3.9.4EV Substance CodeSUB36482
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNeisseria Meningitidis Serogroup W Polysaccharide Conjugated to Tetanus Toxoid Carrier Protein
    D.3.9.3Other descriptive nameNEISSERIA MENINGITIDIS GROUP W-135 POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
    D.3.9.4EV Substance CodeSUB36481
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    Meningococcal infection
    Infección meningocócica
    E.1.1.1Medical condition in easily understood language
    Meningococcal infection
    Infección meningocócica
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10027274
    E.1.2Term Meningococcal infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the vaccine seroresponse sufficiency of meningococcal serogroups A, C, W, and Y after the administration of a booster dose of MenACYW conjugate vaccine in participants who received 1 dose of MenACYW conjugate vaccine approximately 5 years earlier
    Demostrar la suficiencia de la respuesta serológica de la vacuna contra los serogrupos meningocócicos A, C, W y Y después de la administración de una dosis de refuerzo de la vacuna conjugada MenACYW en participantes que recibieron 1 dosis de la vacuna conjugada MenACYW aproximadamente 5 años antes.
    E.2.2Secondary objectives of the trial
    To describe in children who received 1 dose of MenACWY conjugate vaccine approximately 5y earlier:
    - the antibody (Ab) persistence of meningococcal serogroups A, C, W, and Y before the administration of a booster dose of this vaccine
    - the Ab responses to meningococcal serogroups A, C, W, and Y before and 30d after the administration of a booster dose of this vaccine
    - the Ab responses to tetanus toxoid before and 30d after the administration of a booster dose of this vaccine
    - the kinetics of Ab titers against meningococcal serogroups A, C, W, and Y in the first 60 participants, before, 7d and 30d after a booster dose of this vaccine
    - the Ab responses to meningococcal serogroup C before and 30d after a booster dose of MenACYW conjugate vaccine in children who received this vaccine approximately 5y earlier as meningococcal vaccine naïve toddlers (MET51-Group 1) or as meningococcal C-primed toddlers (MET51-Group 3)
    - the safety profile of a booster dose of this vaccine
    Para describir en niños que recibieron 1 dosis de la vacuna conjugada MenACYW aproximadamente 5 años antes: -Persistencia de Abs de serogrupos meningocócicos A, C, W e Y antes de la administración de una dosis refuerzo de la vacuna. -Respuestas de los Abs de serogrupos meningocócicos A, C, W e Y antes y 30 d después de la administración - Respuestas de los Abs al toxoide tetánico antes y 30 d después de la administración -Cinética de los títulos de Abs de serogrupos meningocócicos A, C, W e Y en los primeros 60 sujetos, 7 d antes y 30 d después de la administración.-Respuestas de Abs contra el serogrupo meningocócico C antes y 30 d después de la administración de una dosis refuerzo de la vacuna conjugada MenACYW, en niños que recibieron la vacuna conjugada MenACYW aprox 5 años antes cuando eran niños pequeños sin exposición previa a la vacuna antimeningocócica (MET51, grupo1) o contra el (MenC) (MET51, grupo 3) -Perfil de seguridad de una dosis refuerzo de la vacuna conjugada
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Received MenACYW vaccine in MET51 study (Groups 1 and 3) and completed the study (attended Visit 2)
    - Participant and parent/ legally acceptable representative (LAR) are able to attend all scheduled visits and to comply with all trial procedures
    - Covered by health insurance, if required by local regulations
    - Assent form (AF) has been signed and dated by the participant (if applicable) and informed consent form (ICF) has been signed and dated by the parent(s) or another LAR and by an independent witness, if required by local regulations
    -Haber recibido la vacuna MenACYW en el estudio MET51 (grupos 1 y 3) y completado el estudio (haber asistido a la visita 2)
    -Que el participante y los padres / representante legal (LAR) son capaces de asistir a todas las visitas y cumplir con los procedimientos del ensayo
    - Estar cubierto por un seguro médico, si así lo exigen las normativas locales
    - Que el participante (si corresponde) haya firmado y fechado el formulario de asentimiento (FA) y que los padres o cualquier otro representante legal (LAR) y un testigo independiente si así lo requería la normativa local, hayan firmado y fechado el formulario de consentimiento informado (FCI)
    E.4Principal exclusion criteria
    - Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
    - History of meningococcal infection, confirmed either clinically, serologically, or microbiologically
    - At high risk for meningococcal infection during the trial (specifically but not limited to participants with persistent complement deficiency, with anatomic or functional asplenia, or participants traveling to countries with high endemic or epidemic disease)
    - Personal history of Guillain-Barré syndrome (GBS)
    - Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid containing vaccine
    - Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances
    - Verbal report by parent or LAR of thrombocytopenia or suspected thrombocytopenia, contraindicating intramuscular (IM) vaccination
    - Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination
    - Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (ie, mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, W, or Y) with the exception of licensed MenC vaccination received during infancy (MET51 Group 3), of the single dose of meningococcal vaccine administered as part of study MET51 and of Meningococcal B vaccine
    - Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following trial vaccination except for influenza vaccination, which may be received at least 2 weeks before or after study vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines
    - Receipt of immune globulins, blood or blood-derived products in the past 3 months
    - Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw
    - Participation at the time of study enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
    - Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion
    - Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided
    - Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
    - Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
    - Sospecha o informe de inmunodeficiencia congénita o adquirida, terapias inmunosupresoras tales como quimioterapia anticancerosa o radioterapia durante los 6 meses anteriores o terapia con corticoesteroides sistémicos de largo plazo (prednisona o equivalente durante más de dos semanas consecutivas durante los tres meses anteriores).

    - Antecedentes de infección meningocócica, confirmada clínica, serológica o microbiológicamente
    - Tener alto riesgo de infección meningocócica durante el ensayo (específica pero no exclusivamente, participantes con deficiencia persistente de complementos, con asplenia anatómica o funcional o participantes que viajen a países con alta endemicidad o epidemicidad de la enfermedad).
    -Tener antecedentes personales del Síndrome Guillain-Barré (SGB)
    -Tener antecedentes personales de reacción similar a la de Arthus tras la administración de una vacuna que contenía toxoide tetánico.
    - Hipersensibilidad sistémica conocida a cualquiera de los componentes de la vacuna, o antecedentes de una reacción grave a las vacunas utilizadas en el ensayo o una vacuna que contenga cualquiera de las mismas sustancias.
    - Informe verbal de los padres o LAR de trombocitopenia o sospecha de trombocitopenia, que contraindica la vacunación intramuscular (IM)
    - Haber tenido problemas de coagulación o haber tomado de anticoagulantes en las 3 semanas anteriores a la inclusión, lo que contraindica la vacunación intramuscular.
    - Haber sido vacunado previamente contra la enfermedad meningocócica ya sea con la vacuna del estudio o con otra vacuna (es decir, una vacuna monovalente o polivalente de polisacáridos, o una vacuna antimeningocócica conjugada que contiene los serogrupos A, C, W o Y) con la excepción de la vacuna autorizada MenC recibida durante la infancia (grupo 3 de MET51), de la dosis única de la vacuna antimeningocócica administrada como parte del estudio MET51 y de la vacuna antimeningocócica B.

    - Haber recibido cualquier vacuna en las 4 semanas anteriores a la vacunación del ensayo o tener planificado recibir cualquier vacuna en las 4 semanas siguientes a la vacunación del ensayo, salvo la vacunación antigripal, que se podrá recibir en un intervalo de por lo menos 2 semanas antes o 2 semanas después de cualquiera de las vacunaciones del estudio. Esta excepción incluye las vacunas antigripales pandémicas monovalentes y las vacunas antigripales multivalentes.
    - Haber recibido inmunoglobulinas, sangre o productos derivados de la sangre en los últimos 3 meses.
    - Haber tomado antibióticos, vía oral o inyectable, 72 horas antes de la primera extracción de sangre
    - Estar participando al momento de la inscripción en el estudio (o haber participado en las 4 semanas anteriores a la vacunación del ensayo) o tener planificado participar durante el período de este ensayo en otro ensayo clínico en el cual se investigue una vacuna, un medicamento, un dispositivo médico o un procedimiento médico.
    - Tener alguna enfermedad crónicab que, a juicio del investigador, esté en una etapa que pudiera interferir con la realización o la finalización del estudio.
    - Tener alguna enfermedad/infección aguda moderada o grave (a juicio del investigador) el día de la vacunación o tener alguna enfermedad febril (temp ≥38.0 °C). Un participante potencial no debe ser incluido en el ensayo hasta que se resuelva la afección o haya desaparecido el acontecimiento febril.
    - Estar privado/a de la libertad por orden administrativa o de un tribunal, o estar en una situación de emergencia u hospitalizado/a sin su consentimiento.
    - Ser identificado como hijo/a natural o adoptado/a del investigador o de un empleado con participación directa en el estudio propuesto.
    E.5 End points
    E.5.1Primary end point(s)
    Vaccine seroresponse against meningococcal serogroups A, C, W, and Y; Antibody titers measured by serum bactericidal assay using human complement (hSBA),
    Seroresponse defined as the proportions of participants with an hSBA pre-vaccination titer < 1:8 who achieved a post-vaccination titer ≥ 1:16 or participants with a pre-vaccination titer ≥ 1:8 who achieved a post-vaccination titer at least 4-fold greater than the pre-vaccination titer
    Serorespuesta a la vacuna contra los serogrupos meningocócicos A, C, W e Y; Títulos de anticuerpos medidos por ensayo bactericida sérico utilizando complemento humano (hSBA), Serorespuesta definida como las proporciones de participantes con un título de hSBA previo a la vacunación <1: 8 que alcanzaron un título posterior a la vacunación ≥ 1:16 o participantes con una prevacunación título ≥ 1: 8 que alcanzaron un título posvacunación al menos 4 veces mayor que el título previo a la vacunación
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 01 (pre-vaccination) and Day 31 (postvaccination)
    Día 01 (prevacunación) y Día 31 (posvacunación)
    E.5.2Secondary end point(s)
    1. Antibody titers against meningococcal serogroups A, C, W, and Y before the administration of a booster dose of MenACYW conjugate vaccine; Antibody titers measured by hSBA and serum bactericidal assay using baby rabbit complement (rSBA)
    2. Antibody titers against meningococcal serogroups A, C, W, and Y before and after the administration of a booster dose of MenACYW conjugate vaccine; Antibody titers measured by hSBA and rSBA
    3. Antibody concentrations against tetanus toxoid before and after the administration of a booster dose of MenACYW conjugate vaccine; Antibody concentration measured by immunoglobulin (Ig)G enzyme-linked immunosorbent assay (ELISA)
    4. Antibody titers against meningococcal serogroups A, C, W, and Y before and after the administration of a booster dose of MenACYW conjugate vaccine; Antibody titers measured by hSBA and rSBA in a subset of first 60 participants
    5. Antibody titers against meningococcal serogroup C before and after the administration of a booster dose of MenACYW conjugate vaccine; Antibody titers measured by hSBA and rSBA
    6. Number of participants with immediate adverse events (AEs); Unsolicited systemic AEs reported within 30 minutes after vaccination
    7. Number of participants with solicited injection site reactions or systemic reactions; Pre-defined adverse reactions
    Injection site reactions: pain, redness and swelling
    Systemic reactions: fever, headache, malaise, myalgia
    8. Number of participants with unsolicited AEs; AEs other than solicited reactions
    9. Number of participants with serious adverse events (SAEs); SAEs (including adverse events of special interest [AESIs]) reported throughout the study
    1. Títulos de anticuerpos contra los serogrupos meningocócicos A, C, W e Y medidos por hSBA y análisis bactericida en suero con complemento de cría de conejo (rSBA) en el D01 (valor de referencia) antes de la administración de una dosis de refuerzo de la vacuna conjugada MenACYW
    2. Títulos de anticuerpos contra los serogrupos meningocócicos A, C, W e Y, antes y después de la administración de una dosis de refuerzo de la vacuna conjugada MenACYW; determinados por hSBA y rSBA.
    3. Concentraciones de anticuerpos contra el toxoide tetánico antes y después de la administración de una dosis de refuerzo de la vacuna conjugada MenACYW; Determinación de los niveles de IgG mediante ensayo ELISA.
    4. Títulos de anticuerpos contra los serogrupos meningocócicos A, C, W e Y, antes y después de la administración de una dosis de refuerzo de la vacuna conjugada MenACYW; determinados por hSBA y rSBA en un subconjunto de los primeros 60 participantes.
    5. Títulos de anticuerpos contra los serogrupos meningocócicos A, C, W e Y, antes y después de la administración de una dosis de refuerzo de la vacuna conjugada MenACYW; determinados por hSBA y rSBA.
    Número de participantes con eventos adversos inmediatos (AEs); AA sistémicos no solicitados notificados dentro de los 30 minutos posteriores a la vacunación.
    7. Número de participantes con reacciones en el lugar de la inyección o reacciones sistémicas; Reacciones adversas predefinidas Reacciones en el lugar de la inyección: dolor, enrojecimiento e hinchazón Reacciones sistémicas: fiebre, dolor de cabeza, malestar general, mialgia
    8. Número de participantes EA distintos de las reacciones solicitadas
    9. Número de participantes con eventos adversos graves (SAEs); SAEs (incluidos los eventos adversos de especial interés [AESI]) informados a lo largo del estudio
    E.5.2.1Timepoint(s) of evaluation of this end point
    1: Day 01 (pre-vaccination)
    2, 3, 5: Day 01 (pre-vaccination) and Day 31 (post-vaccination)
    4: Day 01 (pre-vaccination), Day 07 and Day31 (post-vaccination)
    6: Within 30 minutes after vaccination
    7: Within 7 days after vaccination
    8, 9: Within 30 days after vaccination
    1: Día 01 (prevacunación)
    2, 3, 5: Día 01 (prevacunación) y Día 31 (posvacunación)
    4: Día 01 (prevacunación), Día 07 y Día 31 (posvacunación)
    6: Dentro de los 30 minutos posteriores a la vacunación
    7: Dentro de los 7 días posteriores a la vacunación
    8, 9: Dentro de los 30 días posteriores a la vacunación
    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
    Immunogenicity
    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 No
    E.8.1.1Randomised No
    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 No
    E.8.2.4Number of treatment arms in the trial1
    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 EEA32
    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
    LVLS
    La última visita del último paciente
    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 months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months9
    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: 250
    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: 250
    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 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 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
    Children
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state108
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 250
    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
    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 Decision2021-05-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-04
    P. End of Trial
    P.End of Trial StatusOngoing
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