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    Summary
    EudraCT Number:2017-004731-36
    Sponsor's Protocol Code Number:MET58
    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:2018-10-25
    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 number2017-004731-36
    A.3Full title of the trial
    Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine when Administered Concomitantly with Routine Pediatric Vaccines in Healthy Infants and Toddlers in Europe
    Ensayo de inmunogenicidad y seguridad de una vacuna conjugada antimeningocócica tetravalente en investigación administrada de forma concomitante con las vacunas pediátricas de rutina a niños pequeños y lactantes sanos en Europa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine when co-administered with Routine Pediatric Vaccines in Healthy Infants and Toddlers in Europe
    Ensayo de inmunogenicidad y seguridad de una vacuna conjugada antimeningocócica tetravalente administrada de forma concomitante con las vacunas pediátricas de rutina a niños pequeños y lactantes sanos en Europa
    A.4.1Sponsor's protocol code numberMET58
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1183-6653
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/359/2017
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSanofi Pasteur Inc.
    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 Inc.
    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 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 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 number10
    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 number10
    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 number10
    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 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) 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 Nimenrix
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Powder and solvent for solution for injection in pre-filled syringe
    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 µg/ml microgram(s)/millilitre
    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 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 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 µg/ml microgram(s)/millilitre
    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 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 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) 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
    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 (EMI) causada por los serogrupos meningocócicos A, C, Y o W)
    E.1.1.1Medical condition in easily understood language
    Invasive meningococcal disease (IMD)
    enfermedad meningocócica invasiva (EMI)
    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 non-inferiority of the antibody response against meningococcal serogroups A, C, Y, and W following the administration of a 3-dose series of MenACYW conjugate vaccine compared to a 3-dose series of a licensed meningococcal vaccine when each vaccine is given concomitantly with routine pediatric vaccines (10-valent pneumococcal vaccine and diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b [DTaP-IPV-HB-Hib vaccine]) to infants and toddlers 6 weeks to 18 months old
    Demostrar la no inferioridad de la respuesta de anticuerpos contra los serogrupos meningocócicos A, C, W y Y tras la administración de una serie de 3 dosis de la vacuna conjugada MenACYW en comparación con una serie de 3 dosis de Nimenrix®, cuando se administra cada vacuna de forma concomitante con vacunas pediátricas de rutina (PCV10 y vacuna hexavalente) a lactantes y niños pequeños de 6 semanas a 18 meses de edad (grupo 1 frente al grupo 2)
    E.2.2Secondary objectives of the trial
    To demonstrate the non-inferiority of the antibody response against meningococcal serogroups A, C, Y, and W following the administration of 2 doses in infancy of MenACYW conjugate vaccine compared to 2 doses of a licensed meningococcal vaccine when each vaccine is given concomitantly with routine pediatric vaccines (10-valent pneumococcal vaccine and DTaP-IPV-HB-Hib vaccine) to infants and toddlers 6 weeks to 18 months old
    To describe the antibody responses against meningococcal serogroups A, C, Y, and W when MenACYW conjugate vaccine is administered in a 3-dose series concomitantly with 13-valent pneumococcal vaccine, DTaP-IPV-HB-Hib vaccine and mumps, measles and rubella (MMR) vaccine
    To describe the antibody responses against the antigens of the routine pediatric vaccines administered in a 3-dose series concomitantly with MenACYW conjugate vaccine or a licensed meningococcal vaccine
    To describe the safety profile of MenACYW conjugate vaccine and a licensed meningococcal vaccine
    1) Demostrar la no inferioridad de la respuesta de anticuerpos contra los serogrupos meningocócicos A, C, W y Y tras la administración de 2 dosis en la lactancia de la vacuna conjugada MenACYW en comparación con 2 dosis en la lactancia de Nimenrix® cuando se administra cada vacuna de forma concomitante con vacunas pediátricas de rutina (PCV10 y vacuna hexavalente) (grupo 1 frente al grupo 2)
    2) Describir las respuestas de anticuerpos contra los serogrupos meningocócicos A, C, W y Y cuando la vacuna conjugada MenACYW se administra de forma concomitante en una serie de 3 dosis de con la PCV13, la vacuna hexavalente y la vacuna MMR (grupo 3)
    3) Describir las respuestas de anticuerpos contra los antígenos de las vacunas pediátricas de rutina que se administran en una serie de 3 dosis concomitantemente con la vacuna conjugada MenACYW o Nimenrix® (grupos 1, 2 y 3)
    4) Describir el perfil de seguridad de la vacuna conjugada MenACYW y Nimenrix®
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Aged ≥ 42 to ≤ 89 days on the day of the first study visit
    - Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg
    - Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative (and by an independent witness if required by local regulations)
    - Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all study procedures
    - Covered by health insurance according to local regulations
    1) Edad ≥ 42 a ≤ 89 días al día de la primera visita del ensayo.
    2) Nacidos de embarazo a término (≥37 semanas) y con un peso al nacer ≥2,5 kg.
    3) Formulario de consentimiento informado firmado y fechado por los padres u otro representante legal.
    4) El sujeto y el padre/madre/representante legal tienen la posibilidad de asistir a todas las visitas programadas y de cumplir con todos los procedimientos del ensayo.
    5) Cobertura de seguro de salud, de acuerdo con la reglamentación local.
    E.4Principal exclusion criteria
    - Participation at the time of study enrollment (or in the 4 weeks preceding the first study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
    - Receipt of any vaccine in the 4 weeks preceding the first study vaccination or planned receipt of any vaccine in the 4 weeks before and/or following any study vaccination except for influenza vaccination and rotavirus vaccination, which may be received at a gap of at least 2 weeks before or 2 weeks after any study vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines.
    - Receipt or planned to receipt during the study period vaccination against meningococcal disease with either the study vaccine or another vaccine (i.e., mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, Y, or W; or meningococcal B serogroup-containing vaccine)
    - Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae type B (Hib), poliovirus, Streptococcus pneumoniae, measles, mumps, or rubella
    - Receipt of immune globulins, blood or blood-derived products since birth
    - Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks) since birth
    - Family history of congenital or hereditary immunodeficiency, unless the immune competence of the potential vaccine recipient is demonstrated
    - Individuals with blood dyscrasias, leukemia, lymphoma of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems
    - Individuals with active tuberculosis
    - History of Neisseria meningitidis infection, confirmed either clinically, serologically, or microbiologically
    - History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, measles, mumps, rubella, and of Haemophilus influenzae type b, and / or Streptococcus pneumoniae infection or disease
    - At high risk for meningococcal infection during the study (specifically, but not limited to, subjects with persistent complement deficiency, with anatomic or functional asplenia, or subjects traveling to countries with high endemic or epidemic disease)
    - Individuals with underlying conditions predisposing them to invasive pneumococcal disease (specifically, but not limited to, subjects with sickle cell disease or human immunodeficiency virus [HIV] infection)
    - History of any neurologic disorders, including seizures and progressive neurologic disorders
    - History of Guillain-Barré syndrome
    - Known systemic hypersensitivity to any of the vaccine components, or history of a severe allergic reaction (e.g., anaphylaxis) to the vaccine(s) used in the study or to a vaccine containing any of the same substances including neomycin, streptomycin, polymyxin B, glutaraldehyde, formaldehyde, and gelatin
    - Verbal report of thrombocytopenia, contraindicating intramuscular vaccination in the investigator’s opinion
    - Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination in the investigator’s opinion
    - Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
    - Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives, including planning to leave the area of the study site before the end of the study
    - 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.
    - Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw
    - Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
    1) Participación al momento de la inscripción en el ensayo (o en las 4 semanas anteriores a la primera vacunación del ensayo) o participación prevista durante el período del presente ensayo en otro ensayo 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 anteriores a la primera vacunación del ensayo o administración planificada de cualquier vacuna en las 4 semanas anteriores y/o siguientes a cada vacunación del ensayo, salvo la vacunación antigripal y la vacunación contra el rotavirus, que se podrán recibir en un intervalo de por lo menos 2 semanas antes o 2 semanas después de cualquiera de las vacunaciones del ensayo. Esta excepción incluye las vacunas antigripales pandémicas monovalentes y las vacunas antigripales multivalentes.
    3) Administración o administración planificada durante el período de vacunación del ensayo contra la enfermedad meningocócica con la vacuna del ensayo o con otra vacuna (es decir, vacuna de polisacáridos mono o polivalente o vacuna antimeningocócica conjugada de los serogrupos A, C, W o Y; o vacuna antimeningocócica del serogrupo B).
    4) Vacunación previa contra difteria, tétanos, tos ferina, Haemophilus influenzae tipo b (Hib), poliovirus, Streptococcus pneumoniae, sarampión, parotiditis o rubéola
    5) Administración de inmunoglobulinas, sangre o derivados sanguíneos desde el nacimiento.
    6) Inmunodeficiencia congénita o adquirida, conocida o sospechada, o terapias inmunosupresoras, tales como quimioterapia o radioterapia anticancerosa o terapia con corticoides sistémicos de largo plazo (prednisona o equivalente durante más de 2 semanas consecutivas) desde el nacimiento.
    7) Antecedentes familiares de inmunodeficiencia congénita o hereditaria, a menos
    de que se demuestre la capacidad inmunitaria del posible receptor de la vacuna.
    8) Individuos con discrasias sanguíneas, leucemia, linfoma de cualquier tipo, u otras neoplasias malignas que afecten la médula ósea o el sistema linfático.
    9) Individuos con tuberculosis activa.
    10) Antecedentes de infecciones por Neisseria meningitidis con confirmación clínica, serológica o microbiológica
    11) Antecedentes de difteria, tétanos, tos ferina, poliomielitis, hepatitis B, sarampión, parotiditis, rubéola y de Haemophilus influenzae tipo b, y/o enfermedad o infección por Streptococcus pneumoniae.
    12) En alto riesgo de infección meningocócica durante el ensayo (específica pero no exclusivamente, sujetos con deficiencia persistente de complementos, con asplenia anatómica o funcional, o sujetos que viajen a países con alta endemicidad o epidemicidad de la enfermedad).
    13) Las personas con enfermedades subyacentes que las predisponen a una enfermedad neumocócica invasiva (específica pero no exclusivamente, sujetos con enfermedad de células falciformes o infección por virus de inmunodeficiencia humana [VIH])
    14) Antecedentes de cualquier trastorno neurológico, incluyendo convulsiones y trastornos neurológicos progresivos.
    15) Antecedentes de síndrome de Guillain-Barré.
    16) Hipersensibilidad sistémica conocida a cualquiera de los componentes de la vacuna, o antecedentes de alguna reacción alérgica grave (por ejemplo, anafilaxia) a la vacuna utilizada en el ensayo o a una vacuna que contenga cualquiera de las mismas sustancias, incluida la neomicina, estreptomicina, polimixina B, glutaraldehído, formaldehído y gelatina.
    17) Informe verbal de trombocitopenia que contraindique la vacunación intramuscular a juicio del investigador.
    18) 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.
    19) Tener una enfermedad crónica que, a juicio del investigador, está en una etapa que podría interferir con la realización o la finalización del ensayo.
    20) Cualquier situación que, a criterio del investigador, pudiera interferir con la evaluación de los objetivos del ensayo.
    21) Enfermedad/infección aguda moderada o grave (a juicio del investigador) en el día de la vacunación o enfermedad febril (temperatura ≥ 38,0 °C). Un sujeto potencial no debe ser incluido en el ensayo hasta que se resuelva la afección o haya desaparecido el acontecimiento febril.
    22) Recepción de antibioticoterapia oral o inyectada dentro de las 72 horas previas a la primera extracción de sangre
    23) Está identificado como hijo/a natural o adoptado/a del investigador o de un empleado con participación directa en el ensayo propuesto.
    E.5 End points
    E.5.1Primary end point(s)
    Antibody titers against meningococcal serogroups A, C, Y, and W (groups 1 and 2) - Antibody titers will be measured by the serum bactericidal assay using human complement (hSBA) and expressed as geometric mean titers (GMTs)
    Títulos de anticuerpos contra los serogrupos meningocócicos A, C, W y Y (grupo 1 frente al grupo 2)medidos con el análisis bactericida sérico con complemento humano (hSBA) y mostrados como media geométrica de los títulos [GMT]
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 days after dose 3
    30 días después de la dosis 3
    E.5.2Secondary end point(s)
    1. Antibody titers ≥ 1:8 against meningococcal serogroups A, C, Y, and W (groups 1 and 2) - % of participants achieving antibody titers ≥ predefined threshold of 1:8, measured by hSBA
    2. Antibody titers above pre-defined thresholds for meningococcal serogroups A, C, Y, and W (group 3) - % of participants achieving antibody titers ≥ predefined thresholds, measured by hSBA
    3. Antibody titers against meningococcal serogroups A, C, Y, and W (group 3) - Antibody titers will be measured by hSBA and expressed as GMTs
    4. Antibody concentrations against pre-defined thresholds for antigens of DTaP-IPV-HB-Hib vaccine (groups 1, 2, and 3) - % of participants with antibody concentrations ≥ established seroprotection cut-off levels for diphtheria, tetanus, polio, hepatitis B and Hib, and seroresponse rate for anti-pertussis antibodies
    5. Antibody concentrations/titers against antigens of DTaP-IPV-HB-Hib vaccine (groups 1, 2, and 3) - Antibody concentrations/titers will be measured by standard assays for the antigens contained in the vaccine
    6. Antibody concentrations above pre-defined thresholds for antigens of 10-valent pneumococcal vaccine (groups 1 and 2) - % of participants with antibody concentrations ≥ established seroprotection cut-off levels for antigens in the pneumococcal vaccine
    7. Antibody concentrations against antigens of 10-valent pneumococcal vaccine (groups 1 and 2) - Antibody concentrations will be measured by standard assays for the antigens contained in the vaccine
    8. Antibody concentrations above pre-defined thresholds for antigens of 13-valent pneumococcal vaccine (group 3) - % of participants with antibody concentrations ≥ established seroprotection cut-off levels for antigens in the pneumococcal vaccine
    9. Antibody concentrations against antigens of 13-valent pneumococcal vaccine (group 3) - Antibody concentrations will be measured by standard assays for the antigens contained in the vaccine
    10. Antibody concentrations above pre-defined thresholds for antigens of MMR vaccine (groups 1, 2, and 3) - % of participants with antibody concentrations ≥ established seroprotection cut-off levels for antigens in MMR vaccine
    11. Antibody concentrations against antigens of MMR vaccine (groups 1, 2, and 3) - Antibody concentrations will be measured by standard assays for the antigens contained in the vaccine
    12. Solicited injection site reactions and systemic reactions - Injection site reactions: pain, erythema, and swelling; Systemic reactions: fever, vomiting, crying abnormal, drowsiness, appetite lost, and irritability
    1. Títulos de anticuerpos ≥ 1:8 contra los serogrupos meningocócicos A, C, W y Y medidos mediante hSBA, (grupos 1 y 2) - % de pacientes que alcancen títulos de anticuerpos mayor o igual al umbral predefinido de 1:8, medidos mediante hSBA.
    2. Títulos de anticuerpos por encima de los umbrales predefinidos para los serogrupos meningocócicos A, C, Y y W (grupo 3) -% de participantes que alcanzaron títulos de anticuerpos ≥ umbrales predefinidos, medidos por hSBA
    3. Títulos de anticuerpos contra los serogrupos meningocócicos A, C, Y y W (grupo 3) - Los títulos de anticuerpos se medirán con hSBA y se expresarán como GMT
    4. Concentraciones de anticuerpos contra umbrales predefinidos para antígenos de la vacuna DTaP-IPV-HB-Hib (grupos 1, 2 y 3) -% de participantes con concentraciones de anticuerpos ≥ niveles de corte de la seroprotección establecidos para difteria, tétanos, polio, hepatitis B y Hib, y tasa de sero-respuesta para anticuerpos anti-pertussis
    5. Concentraciones / títulos de anticuerpos contra antígenos de la vacuna DTaP-IPV-HB-Hib (grupos 1, 2 y 3) - Las concentraciones / títulos de anticuerpos se medirán mediante ensayos estándar para los antígenos contenidos en la vacuna
    6. Concentraciones de anticuerpos por encima de los umbrales predefinidos para los antígenos de la vacuna antineumocócica 10-valente (grupos 1 y 2) -% de participantes con concentraciones de anticuerpos ≥ niveles de corte de la seroprotección establecidos para los antígenos en la vacuna antineumocócica
    7. Concentraciones de anticuerpos contra antígenos de la vacuna antineumocócica 10-valente (grupos 1 y 2) - Las concentraciones de anticuerpos se medirán por ensayos estándar para los antígenos contenidos en la vacuna
    8. Concentraciones de anticuerpos por encima de los umbrales predefinidos para los antígenos de la vacuna antineumocócica 13-valente (grupo 3) -% de participantes con concentraciones de anticuerpos ≥ niveles de corte de la seroprotección establecidos para los antígenos en la vacuna antineumocócica
    9. Concentraciones de anticuerpos contra antígenos de la vacuna antineumocócica 13 valente (grupo 3) - Las concentraciones de anticuerpos se medirán mediante ensayos estándar para los antígenos contenidos en la vacuna.
    10. Concentraciones de anticuerpos por encima de los umbrales predefinidos para los antígenos de la vacuna MMR (grupos 1, 2 y 3) -% de participantes con concentraciones de anticuerpos ≥ niveles de corte de la seroprotección establecidos para los antígenos en la vacuna triple vírica
    11. Concentraciones de anticuerpos contra antígenos de la vacuna MMR (grupos 1, 2 y 3) - Las concentraciones de anticuerpos se medirán por ensayos estándar para los antígenos contenidos en la vacuna.
    12. Reacciones en el sitio de inyección y reacciones sistémicas. Reacciones en el sitio de inyección: dolor, eritema e hinchazón; Reacciones sistémicas: fiebre, vómitos, llanto anormal, somnolencia, pérdida de apetito e irritabilidad
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. 30 days after dose 2
    2. D0, 30 days after dose 2, before dose 3 and 30 days after dose 3
    3. D0, 30 days after dose 2, before dose 3 and 30 days after dose 3
    4. D0, 30 days after dose 2 and 30 days after dose 3
    5. D0, 30 days after dose 2 and 30 days after dose 3
    6. 30 days after dose 2 and 30 days after dose 3
    7. 30 days after dose 2 and 30 days after dose 3
    8. 30 days after dose 2 and 30 days after dose 3
    9. 30 days after dose 2 and 30 days after dose 3
    10. 30 days after dose 3
    11. 30 days after dose 3
    12. Within 7 days after any injection
    1. 30 días después de la dosis 2
    2. D0, 30 días después de la dosis 2, antes de la dosis 3 y 30 días después de la dosis 3
    3. D0, 30 días después de la dosis 2, antes de la dosis 3 y 30 días después de la dosis 3
    4. D0, 30 días después de la dosis 2 y 30 días después de la dosis 3
    5. D0, 30 días después de la dosis 2 y 30 días después de la dosis 3
    6. 30 días después de la dosis 2 y 30 días después de la dosis 3
    7. 30 días después de la dosis 2 y 30 días después de la dosis 3
    8. 30 días después de la dosis 2 y 30 días después de la dosis 3
    9. 30 días después de la dosis 2 y 30 días después de la dosis 3
    10. 30 días después de la dosis 3
    11. 30 días después de la dosis 3
    12. Dentro de 7 días después de cualquier inyección
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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
    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 months32
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months32
    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: 1540
    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: 1540
    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 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
    Infants and Toddlers
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state160
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1540
    F.4.2.2In the whole clinical trial 1540
    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 Decision2018-10-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-27
    P. End of Trial
    P.End of Trial StatusOngoing
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