Non-Inferiority of Various GSK Bio's Influenza Vaccine Presentations in Adults Aged 65 Years and Over
9 de mayo de 2018 actualizado por: GlaxoSmithKline
Non-Inferiority of GlaxoSmithKline Biologicals' Influenza Vaccine (GSK576389A) 1 Container Over 2 Container Presentation in Adults Aged 65 Years and Over
This observer blind study is designed to compare the immune response of GSK Biologicals' influenza vaccine GSK576389A when administered using various presentations in adults aged 65 years and older.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
The study contains 6 parallel groups, stratified by two age groups: 65-74 years and ≥ 75 years and by two influenza vaccination histories: no influenza vaccination in the last 3 seasons and at least one influenza vaccination in the last 3 seasons.
Tipo de estudio
Intervencionista
Inscripción (Actual)
1596
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
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Soeborg, Dinamarca, 2860
- GSK Investigational Site
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Tartu, Estonia, 50417
- GSK Investigational Site
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Bergen, Noruega, 5094
- GSK Investigational Site
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Elverum, Noruega, 2408
- GSK Investigational Site
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Hamar, Noruega, 2317
- GSK Investigational Site
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Stavanger, Noruega, 4010
- GSK Investigational Site
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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
65 años y mayores (Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female aged 65 years or older at the time of the vaccination.
- Written informed consent obtained from the subject.
- Free of an acute aggravation of the health status as established by clinical evaluation before entering into the study.
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to vaccination, or planned use 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 Visit 2 after vaccination.
- Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
- Vaccination against influenza since January 2007 (including the Northern Hemisphere NH 2006/2007 or NH 2007/08 influenza vaccine).
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- History of hypersensivity to a previous dose of influenza vaccine.
- History of allergy or reactions likely to be exacerbated by any component of the vaccine(s)
- Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by clinical evaluation or pre-existing laboratory screening tests.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products within the three months preceding the first administration of the study vaccine or planned administration during the study.
- Any medical conditions in which intramuscular injections are contraindicated.
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: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: GSK576389A- 2006/2007 Season - 1 container Group
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
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Single dose, intramuscular injection, GSK Bio's influenza vaccine GSK576389A formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
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Experimental: GSK576389A - 2006/2007 Season - 2 containers Group
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
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Single dose, intramuscular injection, GSK Bio's influenza vaccine GSK576389A formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
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Comparador activo: Fluarix 2006/2007 Season Group
Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
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Single dose, intramuscular injection, Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
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Experimental: GSK576389A - 2007/2008 Season - 1 container Group
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
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Single dose, intramuscular injection, GSK Bio's influenza vaccine GSK576389A formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
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Experimental: GSK576389A - 2007/2008 Season - 2 containers Group
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
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Single dose, intramuscular injection, GSK Bio's influenza vaccine GSK576389A formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
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Comparador activo: Fluarix 2007/2008 Season Group
Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
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Single dose, intramuscular injection, Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Haemagglutination Inhibition (HI) Antibody Titers for the H1N1 Vaccine Strain
Periodo de tiempo: At Days 0 and 21
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Antibody titers were expressed as Geometric mean titers (GMTs).
The H1N1 vaccine strains included A/New Caledonia and A/Solomon Islands antigens.
A/New Caledonia vaccine strain was administered to both groups receiving the adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season.
A/Solomon Islands vaccine strain was administered to both groups receiving the adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season.
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At Days 0 and 21
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Duración de los AE locales solicitados
Periodo de tiempo: Durante un período de seguimiento de 7 días (Día 0-6) después de la vacunación
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La duración se definió como el número de días con cualquier grado de síntomas locales.
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Durante un período de seguimiento de 7 días (Día 0-6) después de la vacunación
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Duración de los AE generales solicitados
Periodo de tiempo: Durante un período de seguimiento de 7 días (Día 0-6) después de la vacunación
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La duración se definió como el número de días con cualquier grado de síntomas generales.
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Durante un período de seguimiento de 7 días (Día 0-6) después de la vacunación
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Número de sujetos que informaron cualquier EA de grado 3 y EA no solicitados relacionados
Periodo de tiempo: Durante un período de seguimiento de 21 días (Día 0-20) después de la vacunación
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Los EA no solicitados cubren cualquier EA notificado además de los solicitados durante el estudio clínico y cualquier síntoma solicitado con aparición fuera del período de seguimiento especificado para los síntomas solicitados.
Cualquiera se definió como la aparición de cualquier síntoma no solicitado independientemente del grado de intensidad o la relación con la vacunación.
El grado 3 fue un evento que impidió las actividades normales y relacionado se definió como un EA no solicitado que el investigador evaluó como causalmente relacionado con la vacunación del estudio.
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Durante un período de seguimiento de 21 días (Día 0-20) después de la vacunación
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HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations
Periodo de tiempo: At Days 0 and 21
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Antibody titers were expressed as GMTs.
The vaccine strains included A/New Caledonia or A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
A/New Caledonia vaccine strain was administered to all groups receiving the Northern Hemisphere 2006/2007 influenza season vaccine formulations.
A/Solomon Islands vaccine strain was administered to all groups receiving the Northern Hemisphere 2007/2008 influenza season vaccine formulations.
A/Wisconsin and B/Malaysia vaccine strains were administered to all groups.
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At Days 0 and 21
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The Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations
Periodo de tiempo: At Day 21
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A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.
The vaccine strains included A/New Caledonia (for all groups receiving vaccine formulations for the Northern Hemisphere [NH] 2006/2007 influenza season) or A/Solomon Islands (for all groups receiving vaccine formulations for the NH 2007/2008 influenza season), A/Wisconsin and B/Malaysia antigens.
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At Day 21
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HI Antibody Seroconversion Factors
Periodo de tiempo: At Day 21
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Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/New Caledonia (for all groups receiving vaccine formulations for the Northern Hemisphere [NH] 2006/2007 influenza season) or A/Solomon Islands (for all groups receiving vaccine formulations for the NH 2007/2008 influenza season), A/Wisconsin and B/Malaysia antigens.
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At Day 21
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The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations
Periodo de tiempo: At Days 0 and 21
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A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.
The vaccine strains included A/New Caledonia (for all groups receiving vaccine formulations for the Northern Hemisphere [NH] 2006/2007 influenza season) or A/Solomon Islands (for all groups receiving vaccine formulations for the NH 2007/2008 influenza season), A/Wisconsin and B/Malaysia antigens.
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At Days 0 and 21
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Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Periodo de tiempo: During a 7-day follow-up period (Day 0-6) after vaccination
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Grade 3 ecchymosis, redness and swelling was greater than 100 millimeter (mm) i.e. >100mm and grade 3 pain was considerable pain at rest that prevented normal everyday activities.
Any was occurrence of any local symptom regardless of their intensity grade.
Any for ecchymosis, redness and swelling was >20mm.
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During a 7-day follow-up period (Day 0-6) after vaccination
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Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Periodo de tiempo: During a 7-day follow-up period (Day 0-6) after vaccination
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Any temperature was defined as oral temperature greater than or equal to 38.0 degree centigrade i.e ≥38.0°C, grade 3 temperature was oral temperature ≥39.0°C.
For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a general symptom that prevented normal activity.
Related was a general symptom assessed by the investigator as causally related to the study vaccination.
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During a 7-day follow-up period (Day 0-6) after vaccination
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Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs)
Periodo de tiempo: During a 21-day follow-up period (Day 0-20) after vaccination
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MSCs were defined as an AEs with a medically-attended visit (MAE) i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination.
Any MSC was defined as at least one MSC experienced.
Grade 3 was a MSC that prevented normal activities and related was defined as a MSC assessed by the investigator to be causally related to the study vaccination.
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During a 21-day follow-up period (Day 0-20) after vaccination
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Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Periodo de tiempo: During a 21-day follow-up period (Day 0-20) after vaccination
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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 was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
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During a 21-day follow-up period (Day 0-20) after vaccination
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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 septiembre de 2007
Finalización primaria (Actual)
1 de noviembre de 2007
Finalización del estudio (Actual)
2 de noviembre de 2007
Fechas de registro del estudio
Enviado por primera vez
19 de septiembre de 2007
Primero enviado que cumplió con los criterios de control de calidad
19 de septiembre de 2007
Publicado por primera vez (Estimar)
20 de septiembre de 2007
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 noviembre de 2016
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 110620
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
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
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Formulario de informe de caso anotado
Identificador de información: 110620Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Formulario de consentimiento informado
Identificador de información: 110620Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Protocolo de estudio
Identificador de información: 110620Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Informe de estudio clínico
Identificador de información: 110620Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Especificación del conjunto de datos
Identificador de información: 110620Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Conjunto de datos de participantes individuales
Identificador de información: 110620Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Plan de Análisis Estadístico
Identificador de información: 110620Comentarios 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. .