Safety, Tolerability and Immunogenicity of an Trivalent Inactivated Cell-Culture Influenza Vaccine in Healthy Adults
25 de marzo de 2019 actualizado por: SK Chemicals Co., Ltd.
Randomized, Double-blinded, Controlled, Phase I Trial to Assess Safety, Tolerability and Immunogenicity of 'NBP607(Trivalent Inactivated Cell-Culture Influenza Vaccine)' Compared to Egg-based Influenza Vaccine in Healthy Adult
A randomized, double-blinded, controlled, Phase I clinical trial to assess the safety, tolerability and immunogenicity of 'NBP607(trivalent inactivated cell-culture influenza vaccine)' compared to egg-based influenza vaccine in healthy adult volunteers
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
- Assessment of Safety
- Assessment of Immunogenicity
- Estimated Enrollment: 100
Tipo de estudio
Intervencionista
Inscripción (Actual)
100
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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-
Guro-gu
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Seoul, Guro-gu, Corea, república de, 153-703
- Korea University Guro Hospital
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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
20 años a 59 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- 20 to <60 years of age
- able and willing to give written informed consent prior to study entry
- if female, at least 2 years after post- menopausal and negative result of urine-human chorionic gonadotropin (HCG) test at screening
Exclusion Criteria:
- hypersensitivity to any component of the study medication or chemically related substances, such as allergy to eggs or egg products
- Immunodeficiency disease
- history of hypersensitivity when vaccination, such as Guillain-Barre syndrome
- thrombocytopenia or Coagulation disorders
- experienced fever (>37.5°C) within the past 24 hours or any acute respiratory infection
- receipt of Immunosuppressants or Immunomodulators within the past 3 months
- receipt of blood products or immunoglobulin within the past 3 months
- received influenza vaccine within the past 6 months
- received another vaccine within the past 1 month or plans vaccination within 1 months following the study vaccination
- participation on another clinical trial within 1 month prior to the study vaccination
- history of blood donation within 1 week prior to the study vaccination for plan of blood donation within 7 days following the study vaccination
- any chronic diseases that interfere with the clinical trial or Malignant tumors
- pregnant or breastfeeding
- any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives or might interfere with the safety of the study subject.
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 |
|---|---|
|
Experimental: Group 1
NBP607 0.5ml
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1 dose, 0.5ml, Intramuscular (IM) injection
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|
Comparador activo: Group 2
Agrippal 0.5ml
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1 dose, 0.5ml, Intramuscular (IM) injection
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Incidence rate of solicited local adverse events (AEs)
Periodo de tiempo: Within 21 days after vaccination
|
All AEs were classified and analyzed according to its severity and causality.
The number and percentage of subjects with AEs were analyzed.
Incidence rate, 95% confidence interval as well as number of occurrences were calculated.
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Within 21 days after vaccination
|
|
Incidence rate of solicited systemic AEs
Periodo de tiempo: Within 21 days after vaccination
|
All AEs were classified and analyzed according to its severity and causality.
The number and percentage of subjects with AEs were analyzed.
Incidence rate, 95% confidence interval as well as number of occurrences were calculated.
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Within 21 days after vaccination
|
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Incidence rate of unsolicited AEs
Periodo de tiempo: Within 21 days after vaccination
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All AEs were classified and analyzed according to its severity and causality.
The number and percentage of subjects with AEs were analyzed.
Incidence rate, 95% confidence interval as well as number of occurrences were calculated.
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Within 21 days after vaccination
|
|
Pulse rate at each visit
Periodo de tiempo: 0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
|
Comparisons within each group between pre-/post- vaccination were summarized and presented.
|
0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
|
|
Blood pressure(systolic/diastolic) at each visit
Periodo de tiempo: 0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
|
Comparisons within each group between pre-/post- vaccination were summarized and presented.
|
0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
|
|
Body temperature at each visit
Periodo de tiempo: 0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
|
Comparisons within each group between pre-/post- vaccination were summarized and presented.
|
0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
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Rate of normal/abnormal results in Electrocardiogram (ECG) (ventricular rate, PR interval, QRS, QT, and QTc) collected during screening visit and close-out visit
Periodo de tiempo: Screening visit(0-14 days prior to vaccination)/close-out visit(21-28 days after vaccination)
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Comparisons within each group between pre-/post- vaccination were summarized and presented.
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Screening visit(0-14 days prior to vaccination)/close-out visit(21-28 days after vaccination)
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Rate of normal/abnormal results in physical examination at each visit
Periodo de tiempo: 0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
|
Comparisons within each group between pre-/post- vaccination were summarized and presented.
|
0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
|
|
Rate of normal/abnormal results in clinical laboratory tests(Platelet, Cl, etc.) during screening visit and close-out visit
Periodo de tiempo: Screening visit(0-14 days prior to vaccination)/close-out visit(21-28 days after vaccination)
|
Comparisons within each group between pre-/post- vaccination were summarized and presented.
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Screening visit(0-14 days prior to vaccination)/close-out visit(21-28 days after vaccination)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Seroconversion rate measured by pre-/post-vaccination Haemagglutination Inhibition (HI) titer[Immunogenicity]
Periodo de tiempo: 21-28 days after vaccination
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The proportion of subjects achieving one of the following conditions; i)If the pre-vaccination HI titer were <1:10, subjects achieving an HI titer ≥1:40 after vaccination ii)If the pre-vaccination HI titers were ≥1:10, subjects with a minimum 4-fold rise in HI titer
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21-28 days after vaccination
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Geometric Mean Ratio (GMR) measured by pre-/post-vaccination HI titer[Immunogenicity]
Periodo de tiempo: 21-28 days after vaccination
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The mean increase in geometric mean HI titer
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21-28 days after vaccination
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Seroprotection rate measured by post-vaccination HI titer[Immunogenicity]
Periodo de tiempo: 21-28 days after vaccination
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The proportion of subjects with post-vaccination HI titers of ≥1:40
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21-28 days after vaccination
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Woo Joo Kim, Ph.D., Korea University Guro Hospital
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
1 de septiembre de 2012
Finalización primaria (Actual)
1 de octubre de 2012
Finalización del estudio (Actual)
1 de noviembre de 2012
Fechas de registro del estudio
Enviado por primera vez
12 de diciembre de 2012
Primero enviado que cumplió con los criterios de control de calidad
25 de marzo de 2019
Publicado por primera vez (Actual)
28 de marzo de 2019
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
28 de marzo de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
25 de marzo de 2019
Última verificación
1 de octubre de 2012
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NBP607_Flu_I_2012
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