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    Summary
    EudraCT Number:2016-000749-30
    Sponsor's Protocol Code Number:MET51
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-10-26
    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 number2016-000749-30
    A.3Full title of the trial
    Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Toddlers 12 to 23 Months of Age
    Inmunogenicidad y seguridad de una vacuna conjugada antimeningocócica tetravalente en investigación en niños de 12 a 23 meses
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Toddlers 12 to 23 Months of Age
    Inmunogenicidad y seguridad de una vacuna conjugada antimeningocócica tetravalente en investigación en niños de 12 a 23 meses
    A.4.1Sponsor's protocol code numberMET51
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1161-2935
    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.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSanofi Pasteur
    B.4.2CountryUnited States
    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 number93 485 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 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 nameMenACYW Conjugate Vaccine
    D.3.2Product code 395
    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 GROUP 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 MBq/µg megabecquerel(s)/microgram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNEISSERIA MENINGITIDIS SEROGROUP C POLYSACCHARIDE (PSC) CONJUGATED TO TETANUS TOXOID (TT)
    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 MBq/µg megabecquerel(s)/microgram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNEISSERIA MENINGITIDIS GROUP 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 MBq/µg megabecquerel(s)/microgram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNEISSERIA MENINGITIDIS GROUP W-135 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 MBq/µg megabecquerel(s)/microgram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.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 Nimenrix
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameNimenrix
    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 GROUP 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 MBq/µg megabecquerel(s)/microgram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNEISSERIA MENINGITIDIS SEROGROUP C POLYSACCHARIDE (PSC) CONJUGATED TO TETANUS TOXOID (TT)
    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 MBq/µg megabecquerel(s)/microgram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNEISSERIA MENINGITIDIS GROUP 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 MBq/µg megabecquerel(s)/microgram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNEISSERIA MENINGITIDIS GROUP W-135 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 MBq/µg megabecquerel(s)/microgram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Healthy volunteers (active immunization against invasive meningogoccal disease (IMD) caused by Meningococcal serogroups A, C, Y or W)
    Voluntarios sanos (inmunización activa contra la enfermedad meningocócica invasiva causada por serogrupos meningocócicos A, C, Y o W)
    E.1.1.1Medical condition in easily understood language
    Invasive meningococcal disease (IMD)
    enfermedad meningocócica invasiva
    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 19.0
    E.1.2Level SOC
    E.1.2Classification code 10021881
    E.1.2Term Infections and infestations
    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
    1) To demonstrate the non-inferiority of the antibody response to meningococcal serogroups A, C, Y, and W after a single dose of MenACYW conjugate vaccine or Nimenrix® in toddlers who either are meningococcal vaccine naïve or have received monovalent MenC vaccination during infancy
    2) To demonstrate the non-inferiority of the antibody response to meningococcal serogroups A, C, Y, and W after a single dose of MenACYW conjugate vaccine or Nimenrix® in meningococcal vaccine naïve toddlers
    1) Demostrar la no inferioridad de la respuesta de los anticuerpos contra los serogrupos meningocócicos A, C, Y y W, después de una sola dosis de la vacuna conjugada MenACYW o Nimenrix® en niños pequeños que nunca han recibido una vacuna antimeningocócica o que recibieron una vacuna monovalente contra MenC durante la primera infancia.
    2) Demostrar la no inferioridad de la respuesta de los anticuerpos contra los serogrupos meningocócicos A, C, Y y W, después de una sola dosis de la vacuna conjugada MenACYW o Nimenrix® en niños pequeños que nunca han recibido una vacuna antimeningocócica
    E.2.2Secondary objectives of the trial
    1) To compare the antibody responses (geometric mean titers [GMTs]) to meningococcal serogroups A, C, Y, and W after a dose of MenACYW conjugate vaccine or Nimenrix® as measured by hSBA in toddlers who either are meningococcal vaccine naïve or have received monovalent MenC vaccination during infancy
    2) To compare the antibody responses (GMTs) to meningococcal serogroups A, C, Y, and W after a dose of MenACYW conjugate vaccine or Nimenrix® as measured by hSBA in meningococcal vaccine naïve toddlers
    3) To compare the antibody responses (GMTs) to meningococcal serogroups A, C, Y, and W after a dose of MenACYW conjugate vaccine or Nimenrix® as measured by hSBA in toddlers who received monovalent MenC vaccination during infancy
    1) Comparar las respuestas de los anticuerpos (media geométrica de los títulos [GMT]) contra los serogrupos meningocócicos A, C, Y y W después de la administración de una dosis de la vacuna conjugada MenACYW o de Nimenrix®, medidos mediante ensayo hSBA, en niños pequeños que nunca han recibido una vacuna antimeningocócica o que recibieron una vacuna monovalente MenC durante la primera infancia.
    2) Comparar las respuestas de los anticuerpos (GMT) contra los serogrupos meningocócicos A, C, Y y W después de la administración de una dosis de la vacuna conjugada MenACYW o de Nimenrix® medidas con hSBA en niños pequeños que nunca han recibido una vacuna antimeningocócica.
    3) Comparar las respuestas de los anticuerpos (GMT) contra los serogrupos meningocócicos A, C, Y y W después de la administración de una dosis de la vacuna conjugada MenACYW o de Nimenrix®, medidos mediante ensayo hSBA, en niños pequeños que recibieron una vacuna monovalente MenC durante la primera infancia.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    An individual must fulfill all of the following criteria in order to be eligible for trial enrollment:
    1) Aged 12 to 23 months on the day of the first study visit
    2) Subjects have received all recommended standard-of-care nonmeningococcal vaccinations according to his/her age as per local regulations.
    3) Informed consent form (ICF) has been signed and dated by the parent/legally acceptable representative
    4) Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures
    5) Covered by health insurance if required by local regulations
    6) Subjects have not received any meningococcal vaccine in the second year of life (i.e., from 12 months of age).
    7) For Inclusion in Groups 1 and 2: Subjects must not have received any vaccination against meningococcal disease with either a trial vaccine or a licensed meningococcal vaccine (i.e., polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, W, Y, B; or any monovalent or bivalent meningococcal vaccine).
    8) For Inclusion in Groups 3 and 4:Subjects must have previously received at least 1 dose of licensed monovalent meningococcal C conjugate (MenC) vaccine during infancy (i.e., before 12 months of age)
    Un individuo debe cumplir con todos los siguientes criterios a fin de ser elegible para ser incluido en el ensayo:
    1) Edad de 12 a 23 meses al día de la primera visita del estudio.
    2) Haber recibido todas las vacunaciones estándar no antimeningocócicas recomendadas según su edad conforme a las reglamentaciones locales.
    3) Formulario de consentimiento informado (ICF) firmado y fechado por los padres/representante legal.
    4) El sujeto y los padres/el representante legal tienen la posibilidad de asistir a todas las visitas programadas y de cumplir con todos los procedimientos del estudio.
    5) Cobertura de seguro de salud, si lo requiere la reglamentación local.
    6) Sujetos que no hayan recibido ninguna vacuna antimeningocócica durante el segundo año de vida (es decir, a partir de los 12 meses de edad).
    7) Para la inclusión en los grupos 1 y 2: Los sujetos no deben haber recibido ninguna vacuna contra la enfermedad meningocócica, ya sea una vacuna de ensayo o una vacuna antimeningocócica autorizada (es decir una vacuna polivalente, de polisacáridos o una vacuna antimeningocócica conjugada que contiene los serogrupos A, C, Y, B, o cualquier vacuna antimeningocócica bivalente).
    8) Para la inclusión en los grupos 3 y 4:Los sujetos deben haber recibido previamente al menos 1 dosis de una vacuna antimeningocócica monovalente conjugada, serotipo C, (MenC) durante la primera infancia (es decir, antes de los 12 meses de edad
    E.4Principal exclusion criteria
    An individual fulfilling any of the following criteria is to be excluded from trial enrollment:
    1) Participation 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
    2) Receipt of any vaccine in the 4 weeks (28 days) preceding the trial vaccination or planned receipt of any vaccine prior to Visit 2 except for influenza vaccination, which may be received at least 2 weeks before or after study investigational vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines
    3) Receipt of immune globulins, blood or blood-derived products in the past 3 months
    4) For Groups 1 and 2 only: Vaccination against meningococcal disease with either a trial vaccine or a licensed meningococcal vaccine (i.e., polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, W, Y, B; or any monovalent or bivalent meningococcal vaccine)
    5) For Groups 3 and 4 only: Vaccination against meningococcal disease with either a trial vaccine or a licensed meningococcal vaccine (i.e., polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, W, Y, B; or any monovalent B meningococcal vaccine), except licensed monovalent meningococcal C conjugate (MenC) vaccination received during infancy
    6) 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)
    7) History of meningococcal infection, confirmed either clinically, serologically, or microbiologically
    8) At high risk for meningococcal infection during the trial (specifically, but not limited to, subjects with persistent complement deficiency, with
    anatomic or functional asplenia, or subjects travelling to countries with high endemic or epidemic disease)
    9) 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
    10) Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine
    11) Personal history of Guillain-Barré syndrome (GBS)
    12) Verbal report of thrombocytopenia as reported by the parent/legally acceptable representative contraindicating intramuscular vaccination in the Investigator’s opinion
    13) Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination in the Investigator’s opinion
    14) Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion
    15) Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided.
    16) Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw
    17) Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
    Un individuo que cumpla cualquiera de los siguientes criterios debe ser excluido de la inscripción en el estudio:
    1) Participación en las 4 semanas anteriores a la vacunación del estudio o participación planificada durante el período de este estudio en otro estudio clínico en el cual se investigue una vacuna, un medicamento, un dispositivo médico o un procedimiento médico.
    2) Administración de cualquier vacuna en las 4 semanas (28 días) anteriores a la vacunación del estudio o administración planificada de cualquier vacuna antes de la visita 2, salvo la vacunación antigripal, que se podrá recibir por lo menos 2 semanas antes o después de las vacunas en investigación del estudio. Esta excepción incluye las vacunas antigripales pandémicas monovalentes y las vacunas antigripales multivalentes.
    3) Administración de inmunoglobulinas, sangre o derivados de la sangre en los últimos 3 meses.
    4) Para los grupos 1 y 2 únicamente: Vacunación contra la enfermedad meningocócica ya sea con una vacuna de ensayo o con una vacuna antimeningocócica autorizada (es decir, vacuna antimeningocócica polivalente, de polisacáridos o conjugada que contenga los serogrupos A, C, W, Y, B, o cualquier vacuna antimeningocócica monovalente o bivalente)
    5) Para los grupos 3 y 4 únicamente: Vacunación contra la enfermedad meningocócica ya sea con una vacuna de ensayo o con una vacuna antimeningocócica autorizada (es decir, vacuna antimeningocócica polivalente, de polisacáridos o conjugada que contenga los serogrupos A, C, W, Y, B, o cualquier vacuna antimeningocócica monovalente contra el serogrupo B), con excepción de la vacuna antimeningocócica monovalente conjugada contra el serogrupo C (MenC), durante la primera infancia.
    6) Inmunodeficiencia congénita o adquirida, conocida o sospechada, o recepción de terapias inmunosupresoras, tales como quimioterapia o radioterapia anticancerosa, en los últimos 6 meses, o terapia con corticoesteroides sistémicos de largo plazo (prednisona o equivalente durante más de 2 semanas consecutivas durante los 3 meses anteriores).
    7) Antecedente de infección meningocócica con confirmación clínica, serológica o microbiológica.
    8) En alto riesgo de infección meningocócica durante el estudio (específica pero no exclusivamente, sujetos con deficiencia persistente del complemento, con asplenia anatómica o funcional, o sujetos que viajen a países con alta endemicidad o epidemicidad de la enfermedad).
    9) Hipersensibilidad sistémica conocida a cualquiera de los componentes de la vacuna, o antecedentes de reacciones que pusieran en peligro la vida causadas por la vacuna del estudio o por una vacuna que contuviera alguna de dichas sustancias.
    10) Antecedentes personales de reacción de Arthus tras la administración de una vacuna que contenía toxoide tetánico.
    11) Antecedentes personales de síndrome de Guillain-Barré (GBS).
    12) Informe verbal de trombocitopenia, notificada por los padres/el representante legal, por lo cual quede contraindicada la vacunación intramuscular a juicio del investigador.
    13) Trastornos hemorrágicos o administración de anticoagulantes en las 3 semanas anteriores a la inclusión, por lo cual quede contraindicada una vacunación intramuscular según el criterio del investigador.
    14) Enfermedad crónica que, a juicio del investigador, estuviera en una etapa que pudiera interferir con la realización o la finalización del estudio.
    15) Enfermedad/infección aguda moderada o grave (a juicio del investigador) el día de la vacunación o enfermedad febril (temperatura ≥38,0°C). Un sujeto potencial no debe ser incluido en el estudio hasta que se resuelva la afección o haya desaparecido el evento febril.
    16) Recepción de antibioticoterapia oral o inyectada dentro de las 72 horas previas a la primera extracción de sangre
    17) Está 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)
    1) Antibody titers ≥ 1:8 against meningococcal serogroups A, C, Y, and W measured by serum bactericidal assay using human complement (hSBA) assessed at 30 days (+14 days) after vaccination with MenACYW conjugate vaccine or Nimenrix® in toddlers who either are meningococcal vaccine naïve or have received monovalent MenC vaccination during infancy
    2) Antibody titers.≥ 1:8 against meningococcal serogroups A, C, Y, and W measured by hSBA assessed at 30 days (+14 days) after vaccination with MenACYW conjugate vaccine or Nimenrix® in meningococcal vaccine naïve toddlers
    1) Se encontraron títulos de anticuerpos ≥ 1:8 contra los serogrupos meningocócicos A, C, Y y W medidos mediante el ensayo bactericida en suero con complemento humano (hSBA) realizado 30 días (+14 días) después de la administración de la vacuna conjugada MenACYW o de Nimenrix® en niños pequeños que nunca han recibido una vacuna antimeningocócica o que recibieron una vacuna monovalente MenC durante la primera infancia.
    2) Títulos de anticuerpos ≥ 1:8 contra los serogrupos meningocócicos A, C, Y y W medidos mediante hSBA 30 días (+14 días) después de la administración de la vacuna conjugada MenACYW o de Nimenrix® en niños pequeños que nunca han recibido una vacuna antimeningocócica.
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 days (+14 days) after vaccination
    30 días (+14 días) después de la administración de la vacuna
    E.5.2Secondary end point(s)
    1) GMTs against meningococcal serogroups A, C, Y, and W measured by hSBA before and 30 days (+14 days) after vaccination with MenACYW conjugate vaccine or Nimenrix® in toddlers who either are meningococcal vaccine naïve or have received monovalent MenCvaccination during infancy
    2) GMTs against meningococcal serogroups A, C, Y, and W measured by hSBA before and 30 days (+14 days) after vaccination with MenACYW conjugate vaccine or Nimenrix® in meningococcal vaccine naïve toddlers
    3) GMTs against meningococcal serogroups A, C, Y, and W measured by hSBA before and 30 days (+14 days) after vaccination with MenACYW conjugate vaccine or Nimenrix® in toddlers who received monovalent MenC vaccination during infancy
    1) Comparar las respuestas de los anticuerpos (media geométrica de los títulos [GMT]) contra los serogrupos meningocócicos A, C, Y y W después de la administración de una dosis de la vacuna conjugada MenACYW o de Nimenrix®, medidos mediante ensayo hSBA, en niños pequeños que nunca han recibido una vacuna antimeningocócica o que recibieron una vacuna monovalente MenC durante la primera infancia.
    2) Comparar las respuestas de los anticuerpos (GMT) contra los serogrupos meningocócicos A, C, Y y W después de la administración de una dosis de la vacuna conjugada MenACYW o de Nimenrix® medidas con hSBA en niños pequeños que nunca han recibido una vacuna antimeningocócica.
    3) Comparar las respuestas de los anticuerpos (GMT) contra los serogrupos meningocócicos A, C, Y y W después de la administración de una dosis de la vacuna conjugada MenACYW o de Nimenrix®, medidos mediante ensayo hSBA, en niños pequeños que recibieron una vacuna monovalente MenC durante la primera infancia.
    E.5.2.1Timepoint(s) of evaluation of this end point
    30 days (+14 days) after vaccination
    30 días (+14 días) después de la administración de la vacuna
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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
    Date of availability of final clinical study report
    Fecha de disponibilidad del informe final del estudio clínico
    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 months1
    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 months1
    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: 918
    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: 918
    F.1.1.5Children (2-11years) No
    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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state153
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 918
    F.4.2.2In the whole clinical trial 918
    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 Decision2016-11-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-10-26
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