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Safety, and Immunogenicity of Two Influenza Vaccines in Healthy Subjects 3 to 64 Years Old

16 de septiembre de 2015 actualizado por: Novartis

A Phase III, Observer-Blind, Randomized, Controlled, Multicenter Study to Evaluate Safety, Tolerability, and Immunogenicity of Two Trivalent Subunit Inactivated Influenza Vaccines in Healthy Children Aged 3 to 8 Years, in Healthy Children/Adolescents Aged 9 to 17 Years,and in Healthy Adults Aged 18 to 64 Years

This protocol is designed to evaluate safety, clinical tolerability and immunogenicity of the 2007 southern hemisphere formulation of a Novartis conventional influenza vaccine licensed in the EU and many other worldwide countries, according to the US FDA Draft Guidance for Industry "Clinical data needed to support the licensure of trivalent inactivated influenza vaccine", issued in March 2006, and to evaluate safety, clinical tolerability and immunogenicity of the 2007 southern hemisphere formulation of a Novartis conventional influenza vaccine already licensed in US. The purpose of the control arm is primarily to provide a comparative assessment for safety, not immunogenicity or effectiveness.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

1893

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

  • Argentina
      • Buenos Aires, Argentina
        • Site 2: C1425AWK
      • Cordoba, Argentina
        • Site 1: X5000BJH

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

3 años a 64 años (Niño, Adulto)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Healthy subjects 3 to 64 years of age

Exclusion Criteria:

  • Receipt of other investigational products within 3 months or other vacine within 1 month;
  • Allergy to eggs, egg products, or any other vaccine component;
  • Laboratory confirmed influenza disease within 6 months;
  • Have previously received an influenza vaccination (3 to 8 years only);

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: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Influenza virus vaccine
Biológico: Influenza virus vaccine
Two intramuscular injections of the investigational influenza virus vaccine administered 4 weeks part to group 3 to 8 years of age while one injection was administered to groups 9 to 17 years of age and 18 to 64 years of age.
Comparador activo: Comparator influenza vaccine
Biológico: Comparator influenza vaccine
Two intramuscular injections were administered 4 weeks apart to group 3 to 8 years of age while one injection was administered to groups 9 to 17 years of age and 18 to 64 years of age.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Subjects With Seroprotection, in Healthy Adults 18 to 64 Years of Age
Periodo de tiempo: 21 days after vaccination
To evaluate immunogenicity, measured by seroprotection (percentage of subjects achieving a hemagglutination inhibition [HI] titer ≥40) after one injection of the investigational influenza virus vaccine, administered to healthy adults 18 to 64 years of age. The CBER Guidance states that the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroprotection meet or exceed 70%.
21 days after vaccination
Percentage of Subjects Achieving a Seroconversion Rate, in Adults 18 to 64 Years of Age
Periodo de tiempo: 21 days after vaccination
Seroconversion rate is defined as percentage of subjects achieving seroconversion (defined as negative pre-vaccination serum [HI<10]/ post-vaccination HI titer ≥40) or significant increase defined as at least a 4-fold increase). According to the CBER Guidance, the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconverion/significant increase meet or exceed 40%.
21 days after vaccination

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of Age
Periodo de tiempo: 7 days after vaccination
Solicited local and systemic reactions were assessed after vaccination in adults 18 to 64 years of age.
7 days after vaccination
Percentage of Subjects With Seroprotection, in Healthy Children/Adolescents 9 to 17 Years of Age
Periodo de tiempo: 21 days after vaccination
To descriptively evaluate immunogenicity, measured by seroprotection rate (percentage of subjects achieving a hemagglutination inhibition [HI] titer ≥40) after one injection of investigational influenza virus vaccine, administered to healthy children/adolescents 9 to 17 years of age.
21 days after vaccination
Percentage of Subjects Achieving Seroconversion Rate, in Healthy Children/Adolescents 9 to 17 Years of Age
Periodo de tiempo: 21 days after vaccination
Seroconversion rate is defined as percentage of subjects achieving seroconversion (defined as negative pre-vaccination serum [HI<10]/ post-vaccination HI titer ≥40) or significant increase (defined as at least a 4-fold increase) after one injection of the investigational influenza virus vaccine, administered to healthy children/adolescents 9 to 17 years of age.
21 days after vaccination
Geometric Mean Titers (GMTs), in Healthy Children/Adolescents 9 to 17 Years of Age
Periodo de tiempo: 21 days after vaccination
To evaluate immunogenicity measured by GMTs after one injection of investigational influenza virus vaccine, administered to healthy children/adolescents 9 to 17 years of age.
21 days after vaccination
Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of Age
Periodo de tiempo: 7 days after vaccination
Solicited local and systemic reactions were assessed after vaccination in children/adolescents 9 to 17 years of age.
7 days after vaccination
Percentage of Subjects With Seroprotection, in Healthy Children 3 to 8 Years of Age
Periodo de tiempo: 50 days after last vaccination
To descriptively evaluate immunogenicity, measured by seroprotection rate (percentage of subjects achieving a hemagglutination inhibition [HI] titer ≥40) after two injections of the investigational influenza virus vaccine, in healthy children 3 to 8 years of age.
50 days after last vaccination
Percentage of Subjects Achieving Seroconversion Rate, in Healthy Children 3 to 8 Years of Age
Periodo de tiempo: 50 days after last vaccination
Seroconversion rate is defined as percentage of subjects achieving seroconversion (defined as negative pre-vaccination serum [HI<10]/ post-vaccination HI titer ≥40) or significant increase (defined as at least a 4-fold increase) after two injections of the investigational influenza virus vaccine, in healthy children 3 to 8 years of age.
50 days after last vaccination
Geometric Mean Titers (GMTs), in Healthy Children 3 to 8 Years of Age
Periodo de tiempo: 50 days after last vaccination
To evaluate immunogenicity measured by GMTs after two injections of the investigational influenza virus vaccine, in healthy children 3 to 8 years of age.
50 days after last vaccination
Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.
Periodo de tiempo: 7 days after each vaccination
Solicited local and systemic reactions were assessed after each vaccination, in healthy children 3 to 8 years of age.
7 days after each vaccination
Geometric Mean Titers (GMTs), in Healthy Adults 18 to 64 Years of Age
Periodo de tiempo: 21 days after vaccination
Immunogenicity measured by GMTs after one injection of the investigational influenza virus vaccine, in healthy adults 18 to 64 years of age.
21 days after vaccination

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Novartis

Colaboradores

Novartis Vaccines

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.

Publicaciones Generales

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 abril de 2007

Finalización primaria (Actual)

1 de julio de 2007

Finalización del estudio (Actual)

1 de diciembre de 2007

Fechas de registro del estudio

Enviado por primera vez

23 de abril de 2007

Primero enviado que cumplió con los criterios de control de calidad

23 de abril de 2007

Publicado por primera vez (Estimar)

24 de abril de 2007

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

1 de octubre de 2015

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

16 de septiembre de 2015

Última verificación

1 de septiembre de 2015

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • V71P5
  • IND: 13299

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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