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    Summary
    EudraCT Number:2011-004905-26
    Sponsor's Protocol Code Number:115649
    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:2012-10-25
    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 number2011-004905-26
    A.3Full title of the trial
    Immunogenicity and safety study of GSK Biologicals? Priorix® vaccine (209762) at an end of shelf-life potency compared to Merck & Co., Inc.?s MMR vaccine when both are given on a 2-dose schedule to healthy children in their 2nd year of life.
    Estudio de inmunogenicidad y seguridad de la vacuna Priorix® de GSK Biologicals (209762) con potencia al final de su periodo de validez, comparada con la vacuna SRP de Merck & Co., Inc., administradas conforme a una pauta de 2 dosis a niños sanos en el 2º año de vida.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immunogenicity and safety study of GlaxoSmithKline (GSK) Biologicals? combined measles-mumps-rubella (MMR) vaccine in children in their second year of life.
    Estudio de inmunogenicidad y seguridad de la vacuna combinada del sarampión, rubeola y parotiditis de GlaxoSmithKline (GSK) Biologicals en niños en el 2º año de vida.
    A.3.2Name or abbreviated title of the trial where available
    MMR-161
    A.4.1Sponsor's protocol code number115649
    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 SponsorGlaxoSmithKline
    B.1.3.4CountrySpain
    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 supportGlaxoSmithKline Biologicals
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Biologicals
    B.5.2Functional name of contact pointClinical Disclosure Advisor
    B.5.3 Address:
    B.5.3.1Street AddressRue de l'Institut, 89
    B.5.3.2Town/ cityRixensart
    B.5.3.3Post code1330
    B.5.3.4CountryBelgium
    B.5.4Telephone number442089904466
    B.5.6E-mailGSKClinicalSupportHD@gsk.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 PRIORIX
    D.2.1.1.2Name of the Marketing Authorisation holderGSK Biologicals
    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 namePriorix
    D.3.2Product code 209762
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVirus vivo atenuado de la parotiditis (cepa RIT4385)
    D.3.9.3Other descriptive nameVacuna de virus vivo de la parotiditis (JERYL LYNN)
    D.3.9.4EV Substance CodeSUB21041
    D.3.10 Strength
    D.3.10.1Concentration unit log10 CCID50/dose log10 cell culture infective dose 50/dose
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number3.7
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCEPA SCHWARZ DEL VIRUS DEL SARAMPIÓN (VIVA, ATENUADA)
    D.3.9.3Other descriptive nameCEPA SCHWARZ DEL VIRUS DEL SARAMPIÓN (VIVA, ATENUADA
    D.3.9.4EV Substance CodeSUB25680
    D.3.10 Strength
    D.3.10.1Concentration unit log10 CCID50/dose log10 cell culture infective dose 50/dose
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number2.9
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCEPA WISTAR RA 27/3 DEL VIRUS DE LA RUBEOLA (VIVA, ATENUADA)
    D.3.9.3Other descriptive nameCEPA WISTAR RA 27/3 DEL VIRUS DE LA RUBEOLA (VIVA, ATENUADA)
    D.3.9.4EV Substance CodeSUB21610
    D.3.10 Strength
    D.3.10.1Concentration unit log10 CCID50/dose log10 cell culture infective dose 50/dose
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number2.9
    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 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 VARIVAX
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pasteur MSD SNC
    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 nameVarivax
    D.3.4Pharmaceutical form Powder and solvent in pre-filled syringe for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVirus vivo atenuado de la varicela (cepa OKA/Merck)
    D.3.9.3Other descriptive nameCepa OKA/MERCK del virus dela varicela (vivo, atenuado)
    D.3.9.4EV Substance CodeSUB21611
    D.3.10 Strength
    D.3.10.1Concentration unit PFU plaque forming unit
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number1350
    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: 3
    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 HAVRIX 720, Junior
    D.2.1.1.2Name of the Marketing Authorisation holderGSK Biologicals
    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 nameHavrix 720 Junior
    D.3.4Pharmaceutical form Suspension 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 INNAntígeno del virus de la hepatitis A (VHA), HM 175
    D.3.9.3Other descriptive nameCEPA HM175 DEL VIRUS DE LA HEPATITIS A (INACTIVADA)
    D.3.9.4EV Substance CodeSUB25246
    D.3.10 Strength
    D.3.10.1Concentration unit ELISA unit/dose enzyme-linked immunosorbent assay unit/dose
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number720
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 4
    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 M-M-RVAXPRO
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI PASTEUR MSD SNC
    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.3.1Product nameM-M-RVAXPRO
    D.3.4Pharmaceutical form Powder and solvent for suspension for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCEPA ENDERS' EDMONSTON DEL VIRUS DEL SARAMPIÓN (VIVO, ATENUADO)
    D.3.9.3Other descriptive nameCEPA ENDERS' EDMONSTON DEL VIRUS DEL SARAMPIÓN (VIVO, ATENUADO) PRODUCIDO EN CELULAS EMBRIONARIAS DE POLLO
    D.3.9.4EV Substance CodeSUB25310
    D.3.10 Strength
    D.3.10.1Concentration unit log10 CCID50/dose log10 cell culture infective dose 50/dose
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number3
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCEPA JERYL LYNN (NIVEL B) DEL VIRUS DEL SARAMPIÓN (VIVO, ATENUADO)
    D.3.9.3Other descriptive nameCEPA JERYL LYNN (NIVEL B) DEL VIRUS DEL SARAMPIÓN (VIVO, ATENUADO) PRODUCIDO EN CELULAS EMBRIONARIAS DE POLLO
    D.3.9.4EV Substance CodeSUB25309
    D.3.10 Strength
    D.3.10.1Concentration unit CCID50/dose cell culture infective dose 50/dose
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number12500
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCepa Wistar RA 27/3 del virus de la rubeola (vivo, atenuado)
    D.3.9.3Other descriptive nameCepa Wistar RA 27/3 del virus de la rubeola (vivo, atenuado) producido en fibroblastos diploides de pulmón humano WI-38
    D.3.9.4EV Substance CodeSUB25308
    D.3.10 Strength
    D.3.10.1Concentration unit log10 CCID50/dose log10 cell culture infective dose 50/dose
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number3
    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 measles, mumps and rubella diseases of healthy children in their second year of life).
    Voluntarios sanos (inmunización activa de niños sanos frente al sarampión, la parotiditis y la rubéola en el 2º año de vida)
    E.1.1.1Medical condition in easily understood language
    Measles, mumps and rubella diseases
    Sarampión, parotiditis y rubéola
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10028257
    E.1.2Term Mumps
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10039252
    E.1.2Term Rubella
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10027011
    E.1.2Term Measles
    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 non-inferiority of Inv_MMR vaccine compared to pooled Com_MMR vaccine lots in terms of seroresponse rates to MMR viruses at Day 42.
    ?To demonstrate non-inferiority of Inv_MMR vaccine compared to pooled Com_MMR vaccine lots in terms of geometric mean concentrations (GMCs) for antibodies to MMR viruses at Day 42.
    ?To demonstrate an acceptable immune response of Inv_MMR vaccine in terms of seroresponse rates for MMR viruses at Day 42.
    ?To demonstrate non-inferiority of the Inv_MMR vaccine compared to pooled Com_MMR vaccine lots in terms of seroresponse rates for mumps virus (by Plaque Reduction Neutralization Test (PRNT)) at Day 42.
    ?To demonstrate non-inferiority of the Inv_MMR vaccine compared to pooled Com_MMR vaccine lots in terms of geometric mean titer (GMT) for antibodies to mumps virus (by PRNT) at Day 42.
    -Probar la no inferioridad de la vacuna Inv_MMR frente a la vacuna combinada Com_MMR, en términos de las tasas de respuesta serológica a los virus de SRP a los 42 días.
    -Probar la no inferioridad de la vacuna Inv_MMR frente a la vacuna combinada Com_MMR, en términos de las GMCs para los anticuerpos frente a los virus de SRP a los 42 días.
    -Mostrar una respuesta inmunitaria aceptable a la vacuna Inv_MMR, en términos de las tasas de respuesta serológica a los virus de SRP a los 42 días.
    -Probar la no inferioridad de la vacuna Inv_MMR frente a la vacuna combinada Com_MMR, en términos de las tasas de respuesta serológica al virus de la parotiditis (mediante la prueba de neutralización mediante reducción en placa (PRNT)) a los 42 días.
    -Probar la no inferioridad de la vacuna Inv_MMR frente a la vacuna combinada Com_MMR, en términos de la media geométrica del título (GMT) de los anticuerpos frente al virus de la parotiditis (mediante PRNT) a los 42 días.
    E.2.2Secondary objectives of the trial
    ?To assess the immunogenicity of Inv_MMR_Min and pooled Com_MMR vaccine in terms of seroresponse rates and GMCs for antibodies to measles, mumps and rubella viruses at Day 84 (post Dose 2) (in a sub-cohort of children enrolled in the US).
    ?To assess the immunogenicity of Inv_MMR_Med and pooled Com_MMR vaccine in terms of seroresponse rate and GMCs for antibodies to measles, mumps and rubella viruses at Day 84 (post Dose 2) (in a sub-cohort of children enrolled in the US).
    ?To assess the safety and reactogenicity of Inv_MMR_Min, Inv_MMR_Med, and Com_MMR when co-administered with Varivax, Havrix (to all children), and Prevnar 13 (only to children enrolled in the US).
    -Evaluar la inmunogenicidad de Inv_MMR_Min y de la vacuna combinada Com_MMR, en términos de las tasas de respuesta serológica y las GMCs para los anticuerpos frente a los virus del sarampión, la parotiditis y la rubéola a los 84 días (después de la 2ª dosis) (en una subcohorte de niños reclutada en EE. UU.).
    -Evaluar la inmunogenicidad de Inv_MMR_Med y de la vacuna combinada Com_MMR, en términos de la tasa de respuesta serológica y las GMCs para los anticuerpos frente a los virus del sarampión, la parotiditis y la rubéola a los 84 días (después de la 2ª dosis) (en una subcohorte de niños reclutada en EE. UU.).
    -Evaluar la seguridad y reactogenicidad de Inv_MMR_Min, Inv_MMR_Med y Com_MMR, cuando se coadministran con Varivax, Havrix (a todos los niños) y Prevenar 13 (solo en los niños reclutados en EE. UU.)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ?Male or female child between 12 and 15 months of age at the time of vaccination.
    ?The investigator believes that the parent(s) or Legally Acceptable Representative(s) (LAR(s)) of the child, can, and will comply with the requirements of the protocol.
    ?Written informed consent obtained from the parent(s)/LAR(s) of the child.
    ?Child is in stable health as determined by investigator?s clinical examination and assessment of child?s medical history.
    For US children only:
    ?Child that previously received a 3-dose series of Prevnar 13 at least 60 days prior to study entry.
    ?Niños o niñas de entre 12 y 15 meses de edad en el momento de la vacunación.
    ?Los padres/representantes legales aceptables (RLA) del niño pueden y desean cumplir los requisitos del protocolo, a juicio del investigador.
    ?Obtención del consentimiento informado por escrito de los padres/RLA del niño.
    ?La salud del niño es estable, de acuerdo con la exploración clínica del investigador y la evaluación de la historia clínica del niño.
    -Solo para niños de EE.UU.:
    ?Niño o niña que hubiera recibido con anterioridad una serie de 3 dosis de Prevenar 13 al menos 60 días antes de la inclusión en el estudio
    E.4Principal exclusion criteria
    ?Child in care.
    ?Use of any investigational or non-registered product other than the study vaccine(s) during the period starting 30 days before the day of study vaccination or planned use during the entire study period.
    ?Concurrently participating in another clinical study, in which the child has been or will be exposed to an investigational or a non-investigational product.
    ?Chronic administration of immunosuppressants, or other immune-modifying drugs during the period starting 180 days prior to the first vaccine dose or any planned administration of immunosuppressive and immune-modifying drugs during the entire study.
    -Inhaled and topical steroids are allowed.
    ?Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days prior to study vaccination at Visit 1 and ending at Visit 2 (or ending at Visit 3 for the US post-dose 2 sub-cohort). Please Note:
    -Inactivated influenza (Flu) vaccine and Haemophilus influenzae type b conjugate vaccine (Hib) vaccines may be given at any time during the study, including the day of study vaccination (Flu and Hib vaccines must be administered at a different location than the study vaccine/s).
    -Any age appropriate vaccine may be given starting at Visit 2 (or starting at Visit 3 for the US post-dose 2 sub-cohort), and anytime thereafter.
    ?Administration of immunoglobulins and/or any blood products during the period starting 180 days prior to study vaccination at Visit 1 or planned administration from the date of vaccination through the immunogenicity evaluation at Visit 2, or at Visit 3 for the US post-dose 2 sub-cohort.
    ?History of measles, mumps, rubella, varicella/zoster and/or hepatitis A diseases.
    ?Known exposure to measles, mumps, rubella and/or varicella/zoster during the period starting 30 days prior to the first study vaccination.
    ?Previous vaccination against measles, mumps, rubella, hepatitis A and/or varicella virus.
    ?Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
    ?A family history of congenital or hereditary immunodeficiency.
    ?History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including hypersensitivity to neomycin, latex or gelatin.
    ?Blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems.
    ?Acute disease at the time of enrollment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. Fever is defined as temperature ?38°C/100.4°F by any age appropriate route. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection without fever.
    ?Active untreated tuberculosis based on medical history.
    ?Any other condition which, in the opinion of the Investigator, prevents the child from participating in the study.
    For US children only:
    ?A child that previously received a fourth dose of any pneumococcal conjugate vaccine.
    ?Niños en situación de acogida
    ?Uso de un producto en investigación o no registrado distinto de la o las vacunas del estudio desde 30 días antes de la vacunación del estudio o uso previsto durante todo el período de estudio.
    ?Participación simultánea en otro estudio clínico, en el que el niño ha sido o será expuesto a un producto en investigación o de naturaleza no experimental.
    ?Administración crónica de inmunosupresores u otros inmunomoduladores desde 180 días antes de la primera dosis de la vacuna o administración programada de un inmunosupresor o un inmunomodulador durante todo el estudio.
    ?Se permite el uso inhalado y tópico de esteroides.
    ?Administración programada/administración de una vacuna no prevista en el protocolo del estudio desde 30 días antes de la vacunación del estudio en la visita 1 y hasta la visita 2 (o hasta la visita 3 para la subcohorte EE. UU. post-dosis 2). Recuerde por favor lo siguiente:
    ?La vacuna inactivada de la gripe (Flu) y la vacuna conjugada de Haemophilus influenzae de tipo b (Hib) se pueden administrar en cualquier momento del estudio, incluido el día de la vacunación del estudio (las vacunas antigripal y Hib se administrarán en un lugar distinto al de las vacunas del estudio).
    ?cualquier vacuna adecuada para la edad se podrá administrar a partir de la visita 2 (o de la visita 3 en la subcohorte EE. UU. post-dosis 2), y en cualquier momento posterior.
    ?Administración de inmunoglobulinas y/o cualquier hemoderivado desde 180 días antes de la vacunación del estudio en la visita 1 o administración programada desde la fecha de vacunación hasta la evaluación de la inmunogenicidad en la visita 2, o en la visita 3 para la subcohorte EE. UU. post-dosis 2.
    ?Antecedentes de sarampión, parotiditis, rubéola, varicela/zóster y/o hepatitis A.
    ?Exposición conocida al sarampión, parotiditis, rubéola y/o varicela/zóster desde 30 días antes de la primera vacunación del estudio.
    ?Vacunación previa frente al sarampión, parotiditis, rubéola, hepatitis A y/o varicela.
    ?Cualquier estado de inmunosupresión o inmunodeficiencia conocido o sospechado por la historia clínica y la exploración física
    ?Antecedentes familiares de inmunodeficiencia congénita o hereditaria.
    ?Antecedentes de enfermedades o reacciones alérgicas que pudieran exacerbarse con algún componente de las vacunas, incluida la hipersensibilidad a la neomicina, el látex o la gelatina.
    ?Discrasias sanguíneas, leucemias, linfomas de cualquier tipo u otra neoplasia maligna de la médula ósea o del sistema linfático.
    ?Enfermedad aguda en el momento del reclutamiento. La enfermedad aguda se define como la presencia de una enfermedad moderada o grave, acompañada, o no, de fiebre. La fiebre se define como una temperatura ? 38 °C/100,4 °F por cualquier vía adecuada para la edad. Todas las vacunas se podrán administrar a personas con enfermedades leves, del tipo de diarrea, infección respiratoria alta leve y afebril.
    ?Tuberculosis activa no tratada, según la historia clínica.
    ?Cualquier otro trastorno que, en opinión del investigador, impida al niño participar en el estudio.
    Solo para niños de EE.UU.:
    ?Niño o niña que hubieran recibido una cuarta dosis de cualquier vacuna antineumocócica conjugada.
    E.5 End points
    E.5.1Primary end point(s)
    Immunogenicity of the MMR vaccines:
    ?Seroresponse to measles, mumps and rubella viruses (by ELISA) and to mumps virus (by PRNT).
    ?Measles, mumps and rubella virus antibody concentrations (by ELISA) and mumps virus antibody titers (by PRNT).
    ?Inmunogenicidad de las vacunas SRP:
    -Respuesta serológica a los virus del sarampión, la parotiditis y la rubéola (por ELISA) y al virus de la parotiditis (por PRNT)
    -Concentraciones de los anticuerpos frente a los virus del sarampión, la parotiditis y la rubéola (por ELISA) y títulos de anticuerpos frente al virus de la parotiditis (por PRNT).
    E.5.1.1Timepoint(s) of evaluation of this end point
    At Day 42
    En el día 42
    E.5.2Secondary end point(s)
    Immunogenicity of the MMR vaccines post-dose 2 (US post-dose 2 sub-cohort). In terms of antibody concentration:
    ?Seroresponse to measles, mumps and rubella viruses (by ELISA).
    ?Measles, mumps and rubella virus antibody concentrations (by ELISA)
    ?Inmunogenicidad de las vacunas SRP después de la segunda dosis (subcohorte EE.UU. post-dosis 2). En términos de concentración de anticuerpos
    -Respuesta serológica a los virus del sarampión, la parotiditis y la rubéola (por ELISA).
    -Concentraciones de los anticuerpos frente al virus del sarampión, la parotiditis y la rubéola (por ELISA).
    E.5.2.1Timepoint(s) of evaluation of this end point
    At Day 84
    En el día 84
    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 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, Prevention
    Inmunogenicidad, prevención
    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 concerned13
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA34
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Czech Republic
    Finland
    Malaysia
    Spain
    Thailand
    United States
    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 sujeto
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    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: 4500
    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: 4500
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 state1300
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2300
    F.4.2.2In the whole clinical trial 4500
    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)
    At the end of the study, GSK will provide a second dose of Havrix and/or varicella vaccine to selected non-US countries if local health departments do not routinely provide hepatitis A and varicella vaccination. The second dose of Havrix and varicella vaccine is not part of the study procedures.
    Al finalizar el estudio, GSK proporcionará una segunda dosis de Havrix y/o la vacuna de la varicela en determinados países fuera de EE. UU., si los departamentos de salud locales no suministran por sistema vacunación frente a la hepatitis A y la varicela. La segunda dosis de Havrix y de la vacuna de la varicela no forma parte de los procedimientos del estudio.
    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 Decision2012-12-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-08-18
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