- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00538213
Evaluation of Safety and Immunogenicity of GSK Bio's Influenza Vaccine GSK576389A After Repeated Vaccination in Elderly Adults
Reactogenicity and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK576389A in Elderly Adults (≥66 Years) Previously Vaccinated With the Same Candidate Vaccine. Fluarix™ Will be Used as Reference
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This study is a year 2 revaccination study. First year revaccination was done in study 104887 (NCT00386698). Primary study was study 104886 (NCT00318149). This study involves 2 age groups (based on primary study):
Subjects enrolled in the ≥ 65 years age group in the primary study. Subjects enrolled in the 18-40 years age group in the primary study.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Gent, Bélgica, 9000
- GSK Investigational Site
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Subjects who were previously vaccinated with GlaxoSmithKline Biologicals Fluarix™ or GSK576389A investigational vaccines in the 104887 study (NCT00386698).
- 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 between 19 and 42 years or 66 years and 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.
- If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines 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 21 days after vaccination.
- Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
- Vaccination against influenza since January 2007 with the Northern Hemisphere 2007/2008 influenza vaccine or 2006/2007 influenza vaccine.
- History of confirmed influenza infection since the date of previous vaccination.
- 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. (For corticosteroids, this will mean prednisone, or equivalent, ≥0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- History of hypersensitivity to a previous dose of influenza vaccine.
- History of allergy or reactions likely to be exacerbated by any component of the vaccine(s)
- Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by clinical evaluation (medical history and medical history directed physical examination) or pre-existing laboratory screening tests.
- Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Axillary temperature <37.5°C / Oral temperature of <37.5°C).
- 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.
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Adjuvanted influenza vaccine GSK576389A Group
Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
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Single dose, Intramuscular injection
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Comparador activo: Fluarix young Group
Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
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Dosis única, inyección intramuscular
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Comparador activo: Fluarix elderly Group
Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
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Dosis única, inyección intramuscular
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Duración de los AE generales solicitados
Periodo de tiempo: Día 0-6
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La duración se definió como el número de días con cualquier grado de síntomas generales.
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Día 0-6
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Duración de los AE locales solicitados
Periodo de tiempo: Día 0-6
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La duración se definió como el número de días con cualquier grado de síntomas locales.
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Día 0-6
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Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Periodo de tiempo: Day 0-6
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Grade 3 ecchymosis, redness and swelling was greater than 100 millimeter i.e. >100 mm 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.
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Day 0-6
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Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Periodo de tiempo: Day 0-6
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Any temperature was defined as axillary temperature ≥38.0 degree centigrade (°C), grade 3 temperature was axillary 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 general symptom that prevented normal activity.
Related was general symptom assessed by the investigator as causally related to the study vaccination.
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Day 0-6
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Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs
Periodo de tiempo: Day 0-20
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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 was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
Grade 3 was event that prevented normal activities and related was defined as unsolicited AE assessed by the investigator to be causally related to the study vaccination.
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Day 0-20
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Number of Subjects Reporting at Least One, Grade 3 and Related Medically Significant Conditions (MSCs)
Periodo de tiempo: Day 0-20
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MSCs were defined as AEs with a medically-attended visit i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination.
At least one MSC was defined as at least one MSC experienced.
Grade 3 was MSC that prevented normal activities and Related was defined as MSC assessed by the investigator to be causally related to the study vaccination.
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Day 0-20
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Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Periodo de tiempo: Day 0-20
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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 and related was event assessed by the investigator as causally related to the study vaccination.
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Day 0-20
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Haemagglutination Inhibition (HI) Antibody Titers
Periodo de tiempo: At Days 0 and 21
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Antibody titers were expressed as Geometric mean titers (GMTs).
The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
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At Days 0 and 21
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The Number of Subjects Seropositive to HI Antibodies
Periodo de tiempo: At Days 0 and 21
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Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e. ≥ 1:10.
The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
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At Days 0 and 21
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The Number of Subjects Seroconverted to HI Antibodies
Periodo de tiempo: At Day 21
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Seroconversion was defined as 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 4-fold increase in post-vaccination titer.
The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
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At Day 21
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HI Antibody Seroconversion Factors (SCF)
Periodo de tiempo: At Day 21
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SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
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At Day 21
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The Number of Subjects Seroprotected to HI Antibodies
Periodo de tiempo: At Days 0 and 21
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Seroprotection was defined as serum HI titer ≥1:40 that usually is accepted as indicating protection.
The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
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At Days 0 and 21
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The Geometric Mean (GM) Number of CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
Periodo de tiempo: At Days 0 and 21
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The vaccine strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and Pool FLU antigens and the markers assessed were Cluster of Differentiation 4-All doubles i.e.
CD4-All doubles, CD40 Ligand (CD40L), interferon-gamma (IFN-γ), interleukin-2 (IL-2) and tumor necrosis factor alpha (TNF-α).
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At Days 0 and 21
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The GM Number of CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
Periodo de tiempo: At Days 0 and 21
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The vaccine strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and Pool FLU antigens and the markers assessed were CD8-All doubles, CD40L, IFN-γ, IL-2 and TNF-α.
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At Days 0 and 21
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 110263
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Datos del estudio/Documentos
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Especificación del conjunto de datos
Identificador de información: 110263Comentarios 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: 110263Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Formulario de informe de caso anotado
Identificador de información: 110263Comentarios 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: 110263Comentarios 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: 110263Comentarios 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: 110263Comentarios 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: 110263Comentarios 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. .
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