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Study in Toddlers to Demonstrate Non-inferiority of GSK Biologicals' Hib-MenC & to Evaluate Persistence up to 5 Years.

26 de julio de 2018 actualizado por: GlaxoSmithKline

Study to Demonstrate Non-inferiority of GSK Biologicals' Hib-MenC With Priorix™, Versus MenC-CRM197 Vaccine With Hiberix™ & Priorix™ in Toddlers Primed With Hib But Not MenC & to Evaluate Persistence up to 5 Years After Vaccination.

The purpose of the primary phase of the study is to demonstrate the non-inferiority of a single dose of GSK Biologicals' Haemophilus influenzae type b and meningococcal C (Hib-MenC) conjugate vaccine when given in the second year of life to subjects primed in infancy with a Hib vaccine, but not with a meningococcal serogroup C vaccine, versus commercially available Hib and MenC vaccines.

In the extension phase, at Years 1, 2, 3, 4 & 5, one blood sample is taken at each year to follow the antibody persistence up to 5 years after vaccination. No additional vaccine is administered during the extension phase. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Descripción general del estudio

Descripción detallada

This multicenter study is open and has 2 treatment groups with Hiberix™ + a commercially available MenC vaccine as active controls. Priorix™ is given concomitantly in both groups. In the primary phase, two blood samples are taken from all subjects for immunogenicity analyses: before and one month after vaccination. In the extension phase, at Year 1, 2, 3, 4 & 5, one blood sample is taken at each year to follow the antibody persistence up to 5 years after vaccination. No additional vaccine is administered during the extension phase.

Tipo de estudio

Intervencionista

Inscripción (Actual)

433

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2606
        • GSK Investigational Site
    • New South Wales
      • Randwick, New South Wales, Australia, 2031
        • GSK Investigational Site
      • Westmead, New South Wales, Australia, 2145
        • GSK Investigational Site
    • Queensland
      • Herston, Queensland, Australia, 4029
        • GSK Investigational Site
    • South Australia
      • North Adelaide, South Australia, Australia, 5006
        • GSK Investigational Site
    • Victoria
      • Carlton, Victoria, Australia, 3053
        • GSK Investigational Site
    • Western Australia
      • Perth, Western Australia, Australia
        • GSK Investigational Site

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

1 año a 1 año (Niño)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

Primary phase:

  • Subjects whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
  • A male or female between, and including, 12 and 18 months of age at the time of vaccination.
  • Written informed consent obtained from the parent or guardian of the subject.
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study.
  • Previously completed routine childhood vaccinations to the best of his/her parents'/guardians knowledge.
  • Having completed primary vaccination with two doses of Haemophilus influenzae type b outer membrane protein (Hib-OMP) containing vaccine OR three doses of diphtheria, tetanus, acellular pertussis and Haemophilus influenzae type b (DTPa/Hib) containing vaccine at least 6 months before the study start.

Long-term persistence phase:

- Having participated in the vaccination study 106445

Exclusion Criteria:

For the primary vaccination phase:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Chronic administration (defined as more than 14 days) or planned administration of immuno-suppressants or other immune-modifying drugs within six months prior to vaccination.
  • Planned administration/administration of a vaccine not foreseen by the protocol during the period starting from 30 days before vaccination and ending 30 days after vaccination.
  • Administration of a meningococcal vaccine not foreseen by the study protocol during the period starting at birth and ending at first dose.
  • Previous administration of a booster dose of Hib vaccine.
  • Previous vaccination against measles, mumps, rubella.
  • History of H. influenzae type b, meningococcal serogroup C and/or confirmed measles, mumps or rubella diseases.
  • Known exposure to measles, mumps or rubella within 30 days prior to the start of the study.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection.
  • A family history of congenital or hereditary immunodeficiency.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Major congenital defects or serious chronic illness.
  • History of neurological disorders or more than one episode of febrile convulsion.
  • Acute disease at the time of enrolment.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

Additional exclusion criteria for the long-term persistence phase: to be checked each year.

  • Previous administration of a booster dose of Hib, meningococcal serogroup C vaccines.
  • History of H. influenzae type b, meningococcal serogroup C diseases.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Meningitec + Hiberix Group
Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
One subcutaneous dose at 12-18 months of age
One intramuscular dose at 12-18 months of age.
One intramuscular dose at 12-18 months of age
Experimental: Menitorix Group
Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
One subcutaneous dose at 12-18 months of age
One intramuscular dose at 12-18 months of age
Otros nombres:
  • Hib-MenC
  • Menitorix™

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 0.15 Micrograms Per Milliliter (µg/mL)
Periodo de tiempo: 1 month after vaccination
Anti-PRP antibody concentration greater than or equal to 0.15 µg/mL is indicative of short-term protection.
1 month after vaccination
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Greater Than or Equal to 1:8 Titer
Periodo de tiempo: 1 month after vaccination
rSBA-MenC titers greater than or equal to 1:8 titer are indicative of seroprotection.
1 month after vaccination

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values
Periodo de tiempo: Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccination

rSBA-MenC titers cut-off values assessed were greater than or equal to (≥) 1:8 (indicative of seroprotection) and ≥ 1:128 titers.

Functional anti-meningococcal serogroup C activity (SBA-MenC) was determined by a serum bactericidal test using rabbit complement. For SBA testing at a GlaxoSmithKline (GSK) laboratory up to Year 3 after vaccination, titres were expressed as the reciprocal of the dilution resulting in 50% inhibition. For SBA testing at the Public Health England (PHE), formerly known as Health Protection Agency (HPA), at Year 4, titres were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition.

Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccination
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values
Periodo de tiempo: 5 years after vaccination
rSBA-MenC titers cut-off values assessed were greater than or equal to (≥)1:8 (indicative of seroprotection) and 1:128 titers. For SBA testing at the PHE at Year 5, titres were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition.
5 years after vaccination
Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers
Periodo de tiempo: Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccination.
Titers are given as Geometric Mean Titers (GMTs). Functional anti-meningococcal serogroup C activity (SBA-MenC) was determined by a serum bactericidal test using rabbit complement. For SBA testing at a GlaxoSmithKline (GSK) laboratory up to Year 3 after vaccination, titres were expressed as the reciprocal of the dilution resulting in 50% inhibition. For SBA testing at the PHE at year 4 after vaccination, titres were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition.
Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccination.
Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers
Periodo de tiempo: 5 years after vaccination
Titers are given as Geometric Mean Titers (GMTs). Functional anti-meningococcal serogroup C activity (SBA-MenC) was determined by a serum bactericidal test using rabbit complement. For SBA testing at the PHE at Year 5, titres were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition.
5 years after vaccination
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values
Periodo de tiempo: Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccination
Anti-PRP antibody concentration cut-off values assessed include 0.15 µg/mL (indicative of short-term protection) and 1.0 µg/mL (indicative of long-term protection).
Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccination
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values
Periodo de tiempo: 5 years after vaccination
Anti-PRP antibody concentration cut-off values assessed include 0.15 µg/mL (indicative of short-term protection) and 1.0 µg/mL (indicative of long-term protection).
5 years after vaccination
Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations
Periodo de tiempo: Prior to, 1 month , 1 year, 2 years, 3 years and 4 years after vaccination
Concentrations are given as Geometric Mean Concentrations (GMCs).
Prior to, 1 month , 1 year, 2 years, 3 years and 4 years after vaccination
Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations
Periodo de tiempo: 5 years after vaccination
Concentrations are given as Geometric Mean Concentrations (GMCs).
5 years after vaccination
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Above the Cut-off Values
Periodo de tiempo: Prior to, 1 month, 1 year, 2 years and 3 years after vaccination
Anti-PSC antibody concentration cut-off values assessed include greater than or equal to (≥) 0.30 µg/mL and ≥ 2.0 µg/mL.
Prior to, 1 month, 1 year, 2 years and 3 years after vaccination
Anti-polysaccharide C (Anti-PSC) Antibody Concentrations
Periodo de tiempo: Prior to, 1 month, 1 year, 2 years and 3 years after vaccination
Concentrations given as Geometric Mean Concentrations (GMCs).
Prior to, 1 month, 1 year, 2 years and 3 years after vaccination
Number of Subjects Reporting Solicited Local and General Symptoms
Periodo de tiempo: Within 4 days (Day 0 -Day 3) after vaccination

Solicited local symptoms assessed include pain, redness and swelling at the injection site.

Solicited general symptoms assessed include drowsiness, fever (≥ 38°C), irritability and loss of appetite.

Within 4 days (Day 0 -Day 3) after vaccination
Number of Subjects Reporting Unsolicited Symptoms
Periodo de tiempo: Within 31 days (Day 0 - Day 30) after vaccination
Unsolicited symptom: Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
Within 31 days (Day 0 - Day 30) after vaccination
Number of Subjects Reporting Serious Adverse Events (SAEs)
Periodo de tiempo: Throughout the entire study period (up to year 5)

A serious adverse event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject.

For the long-term persistence phase (Years 1 through 5), only those SAEs that are determined by the investigator to have a causal relationship to the vaccination will be described individually.

Throughout the entire study period (up to year 5)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de junio de 2006

Finalización primaria (Actual)

1 de noviembre de 2007

Finalización del estudio (Actual)

6 de noviembre de 2007

Fechas de registro del estudio

Enviado por primera vez

12 de mayo de 2006

Primero enviado que cumplió con los criterios de control de calidad

12 de mayo de 2006

Publicado por primera vez (Estimar)

16 de mayo de 2006

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

24 de agosto de 2018

Última actualización enviada que cumplió con los criterios de control de calidad

26 de julio de 2018

Última verificación

1 de septiembre de 2016

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 106445
  • 106446 (Otro identificador: GSK)
  • 106449 (Otro identificador: GSK)
  • 106450 (Otro identificador: GSK)
  • 106452 (Otro identificador: GSK)
  • 106454 (Otro identificador: GSK)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

Descripción del plan IPD

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Datos del estudio/Documentos

  1. Plan de Análisis Estadístico
    Identificador de información: 106445
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  2. Formulario de consentimiento informado
    Identificador de información: 106445
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  3. Protocolo de estudio
    Identificador de información: 106445
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  4. Especificación del conjunto de datos
    Identificador de información: 106445
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  5. Conjunto de datos de participantes individuales
    Identificador de información: 106445
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  6. Informe de estudio clínico
    Identificador de información: 106445
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Neisseria meningitidis

Ensayos clínicos sobre Priorix™

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