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Study to Evaluate the Immunogenicity and Safety of a Second Vaccination With the Adjuvanted Influenza Vaccine Candidate

9 de mayo de 2018 actualizado por: GlaxoSmithKline

A Study to Evaluate the Immunogenicity, Safety and Reactogenicity of a Second Vaccination With the Adjuvanted Influenza Vaccine Candidate Compared to Fluarix™ Administered Intramuscularly in Elderly Aged 60 Years and Above.

The purpose of this study is to evaluate the immunogenicity and the safety of a second vaccination with candidate vaccine compared to Fluarix™ administered intramuscularly in elderly aged 60 years and above

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Tipo de estudio

Intervencionista

Inscripción (Actual)

678

Fase

  • Fase 2

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

      • Elverum, Noruega, 2408
        • GSK Investigational Site
      • Hamar, Noruega, 2301
        • GSK Investigational Site
      • Paradis, Noruega, 5231
        • GSK Investigational Site
      • Stavanger, Noruega, 4010
        • 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

60 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • A male or female age 60 years or older at the time of the revaccination, who previously participated in 107192 & 107214 clinical trials.
  • Subjects who the investigator believes can and will comply with the requirements of the protocol
  • Written informed consent obtained from the subject.
  • Free of an acute aggravation of the health status as established by clinical examination before entering into the study.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
  • Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 3 months prior to the first vaccine dose.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
  • Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 30 days after vaccination.
  • History of hypersensitivity to a previous dose of influenza vaccine.
  • History of confirmed influenza infection within the last 12 months.
  • History of allergy or reactions likely to be exacerbated by any component of the vaccine(s)
  • Acute disease at the time of enrolment.

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: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Fluarix Group
Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Single dose, intramuscular injection
Experimental: GSK1247446A Group
Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Single dose, intramuscular injection

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Periodo de tiempo: During the 7-day (Days 0-6) post-vaccination period
Assessed solicited local symptoms were ecchymosis, pain, redness and swelling. Any = Incidence of a particular solicited local symptom regardless of intensity grade. Grade 3 pain = Pain that prevented normal everyday activity. Grade 3 redness/swelling/ecchymosis = Redness/swelling/ecchymosis above 50 millimeters (mm).
During the 7-day (Days 0-6) post-vaccination period
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Periodo de tiempo: During the 7-day (Days 0-6) post-vaccination period
Assessed solicited general symptoms were arthralgia, fatigue, fever, headache, muscle aches and shivering. Any = Incidence of a particular solicited general symptom regardless of intensity grade or relationship with the study vaccination. Any Fever = Axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C). Grade 3 symptom = Symptom that prevented normal activity. Grade 3 fever = Axillary temperature > 39.0°C. Related = Symptom considered by the investigator to have a causal relationship to study vaccination.
During the 7-day (Days 0-6) post-vaccination period
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Periodo de tiempo: During the 30-day (Days 0-29) post vaccination period
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = Any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = Unsolicited AE that prevented normal activity. Related = Unsolicited AE assessed by the investigator as causally related to the vaccination.
During the 30-day (Days 0-29) post vaccination period
Number of Subjects With Any and Related Serious Adverse Events (SAEs).
Periodo de tiempo: During the entire study period (from Day 0 to Day 29)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE = Occurrence of any SAE regardless of intensity grade or relation to vaccination Related = SAE considered by the investigator to have a causal relationship to study vaccination.
During the entire study period (from Day 0 to Day 29)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.
Periodo de tiempo: At Day 21
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.
At Day 21
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.
Periodo de tiempo: At Day 0 and Day 21
A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.
At Day 0 and Day 21
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
Periodo de tiempo: At Day 21
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.
At Day 21
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
Periodo de tiempo: At Day 0 and Day 21
Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia. The seropositivity cut-off assay was 1:10.
At Day 0 and Day 21

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.

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

20 de octubre de 2006

Finalización primaria (Actual)

1 de febrero de 2007

Finalización del estudio (Actual)

5 de febrero de 2007

Fechas de registro del estudio

Enviado por primera vez

10 de octubre de 2006

Primero enviado que cumplió con los criterios de control de calidad

10 de octubre de 2006

Publicado por primera vez (Estimar)

11 de octubre de 2006

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

8 de junio de 2018

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

9 de mayo de 2018

Última verificación

1 de octubre de 2016

Más información

Términos relacionados con este estudio

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. Conjunto de datos de participantes individuales
    Identificador de información: 108708
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  2. Plan de Análisis Estadístico
    Identificador de información: 108708
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  3. Especificación del conjunto de datos
    Identificador de información: 108708
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  4. Informe de estudio clínico
    Identificador de información: 108708
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  5. Protocolo de estudio
    Identificador de información: 108708
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  6. Formulario de consentimiento informado
    Identificador de información: 108708
    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 FluarixTM

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