Non-inferiority Study of GSK Biologicals' Influenza Vaccine GSK576389A Using Different Formulations
9 de mayo de 2018 actualizado por: GlaxoSmithKline
Non-inferiority Study of GlaxoSmithKline Biologicals' Influenza Vaccine GSK576389A Using Different Formulations.
The purpose of this study is to show the non-inferiority of different formulations of GlaxoSmithKline Biologicials' influenza vaccine.
Descripción general del estudio
Estado
Terminado
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Actual)
720
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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Saku, Estonia, 75501
- GSK Investigational Site
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Tallinn, Estonia, 13419
- GSK Investigational Site
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Tartu, Estonia, 50417
- 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 65 years of age or older at the time of vaccination.
- Written informed consent obtained from the subject.
- Free of an acute aggravation of the health status as established by clinical evaluation (medical history and medical history directed examination) before entering into the study.
Exclusion Criteria:
- Suspected (based on clinical symptoms) or confirmed (based on laboratory results) influenza infection within the last 6 months.
- 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.
- 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.
- Previous vaccination against influenza with any seasonal vaccine since July 2007.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- 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) including egg and chicken protein.
- 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.
- Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
- Any medical conditions in which IM 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: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Thiomersal-free FluAS25 adjuvanted vaccine group
Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
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Intramuscular administration, 1 dose
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Experimental: Thiomersal reduced FluAS25 adjuvanted vaccine group
Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
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Intramuscular administration, 1 dose
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Serum Haemagglutination-inhibition (HI) Antibody Titer Against the Three Vaccine Strains
Periodo de tiempo: Days 0 and 21
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Titers were expressed as Geometric Mean Titers (GMTs).
The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
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Days 0 and 21
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of Subjects Seropositive for HI Antibodies Against the Three Vaccine Strains
Periodo de tiempo: Days 0 and 21
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A seropositive subject was defined as a subject with a serum HI titer greater than or equal to 1:10.
The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
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Days 0 and 21
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Number of Subjects Seroconverted for HI Antibodies Against the Three Vaccine Strains
Periodo de tiempo: 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 four-fold increase in post-vaccination titer.
The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
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Day 21
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HI Antibody Seroconversion Factors
Periodo de tiempo: Day 21
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Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
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Day 21
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Number of Subjects Seroprotected for HI Antibodies Against the Three Vaccine Strains
Periodo de tiempo: Days 0 and 21
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A seroprotected subject was defined as a suject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.
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Days 0 and 21
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Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Periodo de tiempo: During a 7-day period after vaccination
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Solicited local symptoms assessed include ecchymosis, pain, redness and swelling.
Any: any symptom regardless of intensity grade.
Grade 3 pain: considerable pain at rest, which prevented normal everyday activities.
Grade 3 ecchymosis, redness and swelling: more than 100 millimeter.
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During a 7-day period after vaccination
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Duration of Solicited Local Symptoms
Periodo de tiempo: During a 7-day period after vaccination
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Duration was expressed as median number of days the symptom persisted.
Solicited local symptoms assessed include ecchymosis, pain, redness and swelling.
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During a 7-day period after vaccination
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Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Periodo de tiempo: During a 7-day period after vaccination
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Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever.
Any: any symptom regardless of intensity grade; any fever: oral temperature greater than or equal to 38 degrees Celsius (°C).
Grade 3: symptoms that prevented normal activity ; Grade 3 fever: oral temperature greater than 39°C.
Related: symptom assessed by the investigator as causally related to the study vaccination.
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During a 7-day period after vaccination
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Duration of Solicited General Symptoms
Periodo de tiempo: During a 7-day period after vaccination
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Duration was expressed as median number of days the symptom persisted.
Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever.
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During a 7-day period after vaccination
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Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Periodo de tiempo: During a 21-day period after vaccination
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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.
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During a 21-day period 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 period after vaccination
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Medically Significant Conditions (MSCs) included all unsolicited adverse events that resulted in a medically attended visit.
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During a 21-day period after vaccination
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Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Periodo de tiempo: During the entire study period (up to Day 21)
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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.
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During the entire study period (up to Day 21)
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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
3 de marzo de 2008
Finalización primaria (Actual)
11 de abril de 2008
Finalización del estudio (Actual)
11 de abril de 2008
Fechas de registro del estudio
Enviado por primera vez
29 de febrero de 2008
Primero enviado que cumplió con los criterios de control de calidad
10 de marzo de 2008
Publicado por primera vez (Estimar)
11 de marzo de 2008
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 111454
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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Plan de Análisis Estadístico
Identificador de información: 111454Comentarios 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: 111454Comentarios 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: 111454Comentarios 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: 111454Comentarios 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: 111454Comentarios 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: 111454Comentarios 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: 111454Comentarios 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. .