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Study to Evaluate the Safety and Immunogenicity of 'IL-YANG Flu Vaccine Quadrivalent Inj' in Healthy Korean Adults

28 de julio de 2020 actualizado por: Il-Yang Pharm. Co., Ltd.

A Randomized, Double-blind, Active Comparator, Phase I/Ⅱa Clinical Trial to Assess the Safety and Immunogenicity of the 'IL-YANG Flu Vaccine Quadrivalent Inj.' in Healthy Korean Adult Subjects

This study evaluates the safety, tolerability and immunogenicity of IL-YANG quadrivalent vaccine versus IL-YANG trivalent vaccine after a single intramuscular administration in healthy Korean males and females 19 to < 65 years of age.

Descripción general del estudio

Descripción detallada

This is a randomized, double-blind, active-controlled, phase I/Ⅱa clinical trial.

During the Part A phase, all safety data collected from the 12 subjects enrolled in the Part A phase will be analyzed to determine the safety and tolerability of the investigational product, which should include any solicited and unsolicited adverse drug reactions occurring for the first 7 days after vaccination and any adverse events occurring for 28 days after vaccination. Antibody titer test will be also performed to evaluate the efficacy (immunogenicity) of the investigational product. During the Part B phase, a total of 72 subjects will be enrolled, and all safety data (including all adverse events) and immunogenicity data will be analyzed.

Tipo de estudio

Intervencionista

Inscripción (Actual)

84

Fase

  • Fase 2
  • Fase 1

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

19 años a 64 años (Adulto)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Healthy men and women 19 to < 65 years of age at screening
  • Body weight within ±20% of ideal body weight at screening
  • Women of childbearing potential must have a negative serum beta-hCG at visit 2; and agree to use a proper contraceptive method for 1 month after vaccination (starting from 3 months before screening), using a medication or device that does not have any drug-interaction with the investigational product.
  • Subjects with no congenital or chronic disease who were considered suitable for the study after screening assessments (investigator's opinion, medical history, physical examination, laboratory test, chest X-ray, and ECG) conducted no later than 28 days prior to vaccination
  • Subjects who were given, and fully understood, the information about the study, and have provided voluntary written informed consent to participate in the study and to comply with all applicable study requirements

Exclusion Criteria:

  • Subject with known allergy to eggs, chicken, or any components of the investigational product
  • Subjects who had received an influenza vaccine within the last 6 months prior to study entry
  • Subjects who have known or suspected infection with HAV, HBV, HCV, HIV or VDRL
  • Subjects who have concurrent or a past history of, immune deficiency disease
  • Subject with a history of Guillain-Barre syndrome
  • Subject with hemophilia or thrombocytopenia or being treated with an anticoagulant, who are at increased risk of serious bleeding during intramuscular injection
  • Subjects with known allergy to a drug, food or latex, who had a history of anaphylaxis
  • Subjects who had an acute fever with body temperature > 38.0 Cº within 72 hours prior to administration of the investigational product or symptoms of suspected acute disease within 14 days prior to administration of the investigational product
  • Subjects who had received another vaccine within 28 days before administration of the investigational product or are planning to receive another vaccine during the study.
  • Subjects who had participated in another clinical trial within the 30 days before administration of the investigational product.
  • Subjects who had previously received blood-derived products (including immunoglobulin) within the last 3 months prior to administration of the Investigational product, or are scheduled to receive a treatment with blood-derived products during the study
  • Subjects who had received, or are scheduled to receive, systemic immunosuppressive therapy, radiation therapy or high-dose steroid therapy within the last 6 months prior to administration of the study
  • Subjects with a history of drug abuse within the last 6 months prior to vaccination, or is suspected of drug abuse
  • Subjects with excessive consumption of caffeine, alcohol, or tobacco
  • Subjects with other clinically significant medical or psychiatric illness who in the investigator's opinion, are not be suitable for the study

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: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: IL-YANG Flu Vaccine QIV 0.5mL
A single 0.5mL dose administrated as an intramuscular injection.
Comparador activo: IL-YANG Flu Vaccine TIV 0.5mL
A single 0.5mL dose administrated as an intramuscular injection.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Seroconversion Rate
Periodo de tiempo: 28 days
Percentage of subjects achieving seroconversion* for HI antibody after vaccination
28 days
Seroprotection Rate
Periodo de tiempo: 28 days
Percentage of subjects achieving seroprotection* for HI antibody after vaccination
28 days

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
GMR
Periodo de tiempo: 28 days
Geometric Mean Ratio of post vaccination HI geometric mean titers
28 days
GMT
Periodo de tiempo: 28 days
Geometric Mean Titer of post vaccination HI geometric mean titers
28 days

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este 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

1 de febrero de 2015

Finalización primaria (Actual)

1 de abril de 2015

Finalización del estudio (Actual)

1 de abril de 2015

Fechas de registro del estudio

Enviado por primera vez

11 de junio de 2015

Primero enviado que cumplió con los criterios de control de calidad

22 de junio de 2015

Publicado por primera vez (Estimar)

25 de junio de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

11 de agosto de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

28 de julio de 2020

Última verificación

1 de julio de 2020

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

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 IL-YANG Flu Vaccine QIV 0.5mL

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