- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01235975
Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Vaccine Given as One Dose to Healthy Subjects Above 56 Years
19 de julio de 2018 actualizado por: GlaxoSmithKline
Phase IIIb Immunogenicity, Safety and Reactogenicity Study of GSK Biologicals' Meningococcal Vaccine [GSK 134612] When Given as One Dose to Healthy Subjects Aged 56 Years or Older
This study evaluates the immunogenicity and safety of the meningococcal conjugate vaccine GSK 134612 given as single dose to healthy adults 56 years or older compared to the meningococcal polysaccharide vaccine MencevaxACWYTM.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
400
Fase
- Fase 3
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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Beirut, Líbano, 1107-2020
- 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
56 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Subjects who the investigator believes can and will comply with the requirements of the protocol
- A male or female 56 years of age or older at the time of the vaccination.
- Written informed consent obtained from the subject.
- Female subjects of non-childbearing potential may be enrolled in the study.
- Non-child-bearing potential is defined as current tubal ligation, hysterectomy, ovariectomy or post-menopause.
Exclusion Criteria:
- Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Concurrent participation 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 non-investigational product.
- Extended administration of immunosuppressants or other immune-modifying drugs within six months prior to the vaccination. Inhaled and topical steroids are allowed.
- Any contra-indication to intramuscular and /or subcutaneous injection.
- Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination and ending 30 days after vaccination. (Vaccination with inactivated influenza vaccines, including H1N1, is allowed at any time during the study as per local recommendations).
- Previous vaccination with meningococcal serogroups A, C, W-135 and Y polysaccharide vaccine within 5 years prior to vaccination.
- Previous vaccination at any time with meningococcal serogroups A, C, W-135 and Y polysaccharide conjugate vaccine.
- Previous vaccination with tetanus toxoid containing vaccine within 5 years prior to vaccination.
- History of meningococcal disease due to serogroups A, C, W-135 or Y.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Family history of congenital or hereditary immunodeficiency.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
- History of neurological disorders and seizures
- History of Guillain-Barre syndrome.
- Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or pre-existing laboratory screening tests.
- Acute disease and/or fever at the time of enrolment.
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine/product or planned administration during the study period.
- Pregnant or lactating female.
- Current chronic alcohol consumption and/or drug abuse.
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: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Grupo A
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Intramuscular injection
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Comparador activo: Grupo B
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Subcutaneous injection
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Vaccine Response to Meningococcal Antigens (MenA, MenC, MenW-135 and MenY)
Periodo de tiempo: One month after vaccination (Month 1)
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Vaccine response for serum bactericidal assay using rabbit complement (rSBA) antibodies against Neisseria meningitides serogroups A, C , W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) was defined as: for initially seronegative subjects [rSBA titer below (<) 1:8], post-vaccination rSBA titer greater than or equal to (≥) 1: 32; for initially seropositive subjects with rSBA titer between 1:8 and 1:128, at least four-fold increase in rSBA titer from pre to post vaccination; and for initially seropositive subjects with rSBA titer ≥1:128, at least two-fold increase in rSBA titer from pre to post vaccination.
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One month after vaccination (Month 1)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value
Periodo de tiempo: At Day 0 and Month 1
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The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8.
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At Day 0 and Month 1
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Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value
Periodo de tiempo: At Day 0 and Month 1
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The cut-off value for the rSBA titers was greater than or equal to (≥) 1:128.
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At Day 0 and Month 1
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rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
Periodo de tiempo: At Day 0 and Month 1
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Antibody titers were presented as geometric mean titers (GMTs).
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At Day 0 and Month 1
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Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations ≥ the Cut-off Value
Periodo de tiempo: At Day 0 and Month 1
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The cut-off value for the anti-polysaccharide concentrations was greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL).
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At Day 0 and Month 1
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Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations ≥ the Cut-off Value
Periodo de tiempo: At Day 0 and Month 1
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The cut-off value for the anti-polysaccharide concentrations was greater than or equal to (≥) 2.0 micrograms per milliliter (μg/mL).
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At Day 0 and Month 1
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Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations
Periodo de tiempo: At Day 0 and Month 1
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Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (μg/mL).
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At Day 0 and Month 1
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Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations ≥ the Cut-off Value
Periodo de tiempo: At Day 0 and Month 1
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The cut-off value for the anti-TT concentrations was greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).
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At Day 0 and Month 1
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Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations
Periodo de tiempo: At Day 0 and Month 1
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Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).
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At Day 0 and Month 1
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Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Periodo de tiempo: Within 4 days (Day 0 to 3) post-vaccination
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Assessed solicited local symptoms were pain, redness and swelling.
Any = occurrence of the symptom regardless of intensity grade.
Grade 3 pain = significant pain at rest or pain that prevented normal every day activities.
Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
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Within 4 days (Day 0 to 3) post-vaccination
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Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Periodo de tiempo: Within 4 days (Day 0 to 3) post-vaccination
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Assessed solicited general symptoms were fatigue,gastrointestinal symptoms, headache and temperature [defined as orally temperature equal to or above (≥) 37.5 degrees Celsius (°C)].
Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination.
Grade 3 symptom = symptom that prevented normal activity.
Grade 3 temperature = temperature above (>) 39.5 °C.
Related = symptom assessed by the investigator as causally related to the study vaccination.
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Within 4 days (Day 0 to 3) post-vaccination
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Number of Subjects With Any Unsolicited Adverse Events (AEs)
Periodo de tiempo: Within 31 days (Day 0 to 30) after vaccination
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An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
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Within 31 days (Day 0 to 30) after vaccination
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Number of Subjects With Serious Adverse Events (SAEs)
Periodo de tiempo: Within 31 days (Day 0 to 30) after vaccination
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Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
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Within 31 days (Day 0 to 30) after vaccination
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Number of Subjects With New Onset Chronic Illnesses (NOCI)
Periodo de tiempo: Within 31 days (Day 0 to 30) after vaccination
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NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
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Within 31 days (Day 0 to 30) 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 (Actual)
30 de noviembre de 2010
Finalización primaria (Actual)
29 de julio de 2011
Finalización del estudio (Actual)
3 de agosto de 2011
Fechas de registro del estudio
Enviado por primera vez
4 de noviembre de 2010
Primero enviado que cumplió con los criterios de control de calidad
4 de noviembre de 2010
Publicado por primera vez (Estimar)
7 de noviembre de 2010
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
20 de agosto de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
19 de julio de 2018
Última verificación
1 de julio de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 113807
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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Informe de estudio clínico
Identificador de información: 113807Comentarios 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: 113807Comentarios 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: 113807Comentarios 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: 113807Comentarios 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: 113807Comentarios 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: 113807Comentarios 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 Meningococcal vaccine GSK 134612
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GlaxoSmithKlineTerminadoInfecciones MeningocócicasEstados Unidos, Canadá
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GlaxoSmithKlineTerminadoInfecciones MeningocócicasFinlandia
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GlaxoSmithKlineTerminadoInfecciones MeningocócicasTailandia, Panamá, Filipinas