- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01512056
Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine,Formulation 2011-2012, in Dialysis Patients
Descripción general del estudio
Descripción detallada
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 4
Contactos y Ubicaciones
Ubicaciones de estudio
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Tainan, Taiwán, 704
- Reclutamiento
- National Cheng Kung University Hospital
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Contacto:
- Junne Ming Sung, MD
- Número de teléfono: 2594 886-6-2353535
- Correo electrónico: jmsung@mail.ncku.edu.tw
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Contacto:
- Yu Tzu Chang, MD and Msc
- Número de teléfono: 2593 886-6-2353535
- Correo electrónico: kangxiemperor@gmail.com
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Investigador principal:
- Junne Ming Sung, MD
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Sub-Investigador:
- Yu Tzu Chang, MD and Msc
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Sub-Investigador:
- Yi Ching Yang, MD
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Sub-Investigador:
- Meng Te Lin, MD
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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:
- Males and non-pregnant females and aged more than 18 years;
- Willing and able to adhere to visit schedules and all study requirements;
- Subjects read and signed the study-specific informed consent.
Exclusion Criteria:
- Subject or his/her family is employed by the participated hospital;
- Subjects received 2010-2011 seasonal influenza vaccine within the previous 6 months;
- History of hypersensitivity to eggs or egg protein or similar pharmacological effects to study medication;
- Personal or family history of Guillain-Barré Syndrome;
- An acute febrile illness within 1 week prior to vaccination;
- Current upper respiratory illness, including the common cold or nasal congestion within 72 hours;
- Subjects with influenza-like illness as defined by the presence of fever (temperature ≥ 38°C) and at least two of the following four symptoms: headache, muscle/joint aches and pains (e.g. myalgia/arthralgia), sore throat and cough;
- Female subjects who are pregnant during the study.
- Patients who receive hemodialysis therapy less than 3 months.
- Treatment with an investigational drug or device, or participation in a clinical study, within 3 months before consent;
- Immunodeficiency, or under immunosuppressive treatment.
- Receipt of any vaccine within 1 week prior to study vaccination or expected receipt between Visit 1 (study vaccination) and Visit 2 (final collection of blood samples);
- Receipt of any blood products, including immunoglobulin in the prior 3 months;
- Any severe illness needed to be hospitalization within three months.
- Underlying condition in the investigators' opinion may interfere with evaluation of the vaccine.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- 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: the immunogenicity profiles of the AdimFlu-S
Experimental group: to receive either only one dose of influenza vaccine at day 0 or one more booster vaccination 3 weeks later. Negative control group: dialysis patients who refused to receive influenza vaccination. |
All enrolled participants will be divided into 3 groups: participants refused to receive vaccination, those receive either one (week 0) or one more booster vaccination (week 0 and week 3).
Each dose of vaccine contains 15μg antigen of each virus strain suggested by WHO (A/California/7/2009 (H1N1);A/Perth/16/2009 (H3N2);B/Brisbane/60/2008).
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Sin intervención: The safety outcome of the vaccine
Any adverse effect, including systemic or local site, will be recorded during the study period.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change of antibody titer before and after influenza vaccination
Periodo de tiempo: 18 weeks
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The primary endpoint will be the seroprotection rate which is defined as the proportion of subjects with HI titer ≥ 1:40.
MicroNT-ELISA assay will also be used to evaluate the immune response post vaccination.
The immune response based on microNT-ELISA antibody titers would be reported as antibody titer ≥1: 40 or ≥ 1:160 respectively because no threshold of protective NT antibody titer is clearly defined by the international guidelines.
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18 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Seroresponse rate
Periodo de tiempo: 0, 3 weeks, 6 weeks, 9 weeks and 18 weeks
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The seroconversion is defined as the HI titer of the post-vaccination serum is at least 1:40 for those who had a negative pre-vaccination HI serum titer or a four-fold or greater increase in HI titers in subjects who had a positive pre-vaccination HAI serum titer.
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0, 3 weeks, 6 weeks, 9 weeks and 18 weeks
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Seroresponse rate
Periodo de tiempo: 0, 3 weeks, 6 weeks, 9 weeks and 18 weeks
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The seroresponse is defined as HI or micro-NT titer of the post-vaccination serum is at least 4-fold increase of the HI or micro-NT titer after vaccination. Geometric mean folds increase in HI or micro-NT titer. |
0, 3 weeks, 6 weeks, 9 weeks and 18 weeks
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the safety and tolerability profiles of the vaccine
Periodo de tiempo: 0, 3 week, 6 weeks, 9 weeks, 18 weeks
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evaluate the safety and tolerability profiles including the presence or absence of the pre-specified reactogenicity events and other serious/non-serious adverse events of the AdimFlu-S manufactured by Adimmune Corporation.
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0, 3 week, 6 weeks, 9 weeks, 18 weeks
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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 (Estimar)
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
- BR-100-086
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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