Immunogenicity and Safety Study of a GSK Influenza Vaccine Candidate in Adults.
9 de mayo de 2018 actualizado por: GlaxoSmithKline
Immunogenicity and Safety Study of a GSK Influenza Vaccine Candidate GSK 2115160A in Adults.
The purpose of this study is to evaluate the safety and immunogenicity of GSK influenza vaccine candidate compared to a licensed trivalent influenza vaccine in adults.
Descripción general del estudio
Estado
Terminado
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Actual)
420
Fase
- Fase 1
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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Hradec Kralove, Chequia, 500 03
- 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
18 años a 60 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female between, and including, 18 and 60 years of age at the time of the vaccination.
- Written informed consent obtained from the subject.
- If the subject is female, she must be of non-childbearing potential, 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 vaccine(s) within 30 days preceding the administration of study vaccine, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 3 months prior to administration of the vaccine.
- Administration of a vaccine not foreseen in the study protocol from 30 days before vaccination up to 21 days post vaccination.
- Confirmed influenza infection within a year preceding the study start.
- Administration of an influenza vaccine during Northern Hemisphere season 2007-2008.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- History of hypersensitivity to a previous dose of influenza vaccine
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
- Acute disease at the time of enrolment.
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Administration of immunoglobulins and/or any blood products within the three months preceding the administration of study vaccine or planned administration during the study period.
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
- History of chronic alcohol consumption and/or drug abuse.
- Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.
- History of administration of experimental/licensed vaccine.
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: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Quadrivalent influenza vaccine GSK 2115160A Group 1
Subjects in this group received 1 full dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
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Single intramuscular dose on Day 0.
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Experimental: Quadrivalent influenza vaccine GSK 2115160A Group 2
Subjects in this group received 1 low dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
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Single intramuscular dose on Day 0.
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Comparador activo: Trivalent influenza vaccine GSK 2115160A Group 1
Subjects in this group received 1 low dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
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Single intramuscular dose on Day 0.
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Comparador activo: Trivalent influenza vaccine GSK 2115160A Group 2
Subjects in this group received 1 full dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
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Single intramuscular dose on Day 0.
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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 Titers, Against Each of the Vaccine Influenza Virus Strains.
Periodo de tiempo: At Day 0 and Day 21
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Antibody titers were expressed as Geometric mean titers (GMTs).The vaccine influenza strains included A/Solomon Islands,A/Wisconsin,B/Malaysia and B/Jiangsu antigens.
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At Day 0 and Day 21
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Number of Subjects Seroconverted for HI Antibodies Against the Vaccine Influenza Strains.
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 less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer.
The vaccine influenza strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and B/Jiangsu antigens.
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At Day 21
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HI Antibody Seroconversion Factors Against the Vaccine Influenza Strains
Periodo de tiempo: 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 Influenza vaccine strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and B/Jiangsu antigens.
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Day 21
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Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains.
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 ≥1:40 that usually is accepted as indicating protection.
The Influenza vaccine strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and B/Jiangsu antigens.
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At 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 (Days 0-6) follow-up period after vaccination
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Solicited local symptoms assessed were pain, redness and swelling.
Any was defined as occurrence of any specified solicited local symptoms reported irrespective of intensity grade.
Grade 3 pain was defined as considerable pain that prevented normal activity.
Grade 3 redness and swelling were defined as redness/swelling above 100 millimeters (mm).
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During a 7 day (Days 0-6) follow-up period after vaccination
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Number of Subjects With Any and Grade 3 Solicited Local Symptoms Reported by the Former GSK Rules of Grading.
Periodo de tiempo: During a 7-day follow-up period (Days 0-6) after vaccination
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Solicited local symptoms assessed by the former GSK rules of grading were pain, redness and swelling.
Any was defined as occurrence of any specified solicited local symptoms reported irrespective of intensity grade.
Grade 3 pain was defined as pain that prevented normal activity.
Grade 3 redness and swelling were defined as redness/swelling above 50 millimeters (mm).
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During a 7-day follow-up period (Days 0-6) 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 follow-up period (Days 0-6) after vaccination
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Solicited general symptoms assessed were arthralgia, fatigue, headache, myalgia, nausea, shivering and fever.
Any =occurrence of any specified solicited general symptoms reported irrespective of intensity grade or relationship to vaccination.
Any fever = oral temperature ≥ 38.0 degrees Celsius (°C).. Grade 3 symptoms = symptoms that prevented normal activities.
Grade 3 fever = oral temperature ≥39.0°C.
Related = symptoms considered by the investigator to have a causal relationship to vaccination
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During a 7-day follow-up period (Days 0-6) after vaccination
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Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading.
Periodo de tiempo: During a 7-day follow-up period (Days 0-6) after vaccination
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Solicited general symptoms assessed by the former GSK rules of grading were arthralgia, fatigue, headache, myalgia, nausea, shivering and fever.
Any = occurrence of any specified solicited general symptoms reported irrespective of intensity grade or relationship to vaccination.
Any fever = oral temperature ≥ 37.5 °C.
Grade 3 symptoms = symptoms that prevented normal activities.
Grade 3 fever = oral temperature above 39.0°C. .
Related = symptoms considered by the investigator to have a causal relationship to vaccination.
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During a 7-day follow-up period (Days 0-6) after vaccination
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Number of Subjects Reporting Any Medically Significant Conditions (MSCs) and Auto-immune Diseases (AIDs).
Periodo de tiempo: During the entire study period (Days 0-180)
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MSCs were defined as those adverse events (AEs) prompting emergency room visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination.
AIDs include a large group of diseases characterized by abnormal functioning of the immune system that causes immune system to produce antibodies against own tissues.
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During the entire study period (Days 0-180)
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Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AE(s).
Periodo de tiempo: During a 21 day (Days 0-20) follow-up 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.
Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination
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During a 21 day (Days 0-20) follow-up 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 (Days 0-180)
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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 the entire study period (Days 0-180)
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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
14 de julio de 2008
Finalización primaria (Actual)
28 de enero de 2009
Finalización del estudio (Actual)
28 de enero de 2009
Fechas de registro del estudio
Enviado por primera vez
11 de julio de 2008
Primero enviado que cumplió con los criterios de control de calidad
11 de julio de 2008
Publicado por primera vez (Estimar)
14 de julio 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 marzo de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 111295
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 consentimiento informado
Identificador de información: 111295Comentarios 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: 111295Comentarios 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: 111295Comentarios 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: 111295Comentarios 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: 111295Comentarios 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: 111295Comentarios 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: 111295Comentarios 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. .