Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children, Adolescents and Adults (3 to 64 Years)
A Randomized, Open Label, Single Center, Dose- and Regimen-Ranging Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of an Adjuvanted and Non-Adjuvanted Egg-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Children and Adults Ages 3 to 64 Years
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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San Jose, Costa Rica
- Instituto de Atencion Pediatrica, Avenida 0-2 Calle 22, Paseo Colon del Restaurante La, Bastilla 50 metros Sur, Edificio 5.
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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:
- Children, adolescents, and adults 3 to 64 years of age in good health as determined by medical history, physical assessment and clinical judgement of the investigator and without influenza within the past 6 months.
Exclusion Criteria:
- History of serious disease.
- History of serious reaction following administration of vaccine or hypersensitivity to vaccine components.
- Known or suspected impairment/alteration of immune function.
- Receipt or planned receipt of seasonal trivalent influenza vaccine within 1 week before or after each study vaccination.
For additional entry criteria, please refer to protocol.
Plan de estudios
¿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 |
|---|---|
|
Experimental: 2x7.5adj
Two doses of MF59 adjuvanted (adj) A/H1N1
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MF59 adjuvanted (adj) egg-derived A/H1N1 with traces of Thiomersal
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Experimental: 7.5adj_1_8
MF59 adjuvanted (adj) A/H1N1 on days 1 and 8
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MF59 adjuvanted (adj) egg-derived A/H1N1 with traces of Thiomersal
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Experimental: 7.5adj_1_22
MF59 adjuvanted (adj) A/H1N1 on study days 1 and 22
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MF59 adjuvanted (adj) egg-derived A/H1N1 with traces of Thiomersal
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Experimental: 15_1_22
A/H1N1 on study days 1 and 22
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Unadjuvanted egg-derived A/H1N1 with traces of Thiomersal
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Experimental: 2x15_1_22
Two doses of A/H1N1 (one in each arm) on study days 1 and 22
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Unadjuvanted egg-derived A/H1N1 with traces of Thiomersal
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Percentage of Subjects With Seroconversion and HI Titer ≥1:40 in Children 3 to 17 Years of Age
Periodo de tiempo: Day 1 to day 387
|
Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. The analyses were performed on the Per-Protocol Set (PPS). |
Day 1 to day 387
|
|
Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age
Periodo de tiempo: Day 1 to day 387
|
Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. Analyses were performed on the Per-Protocol set (PPS). |
Day 1 to day 387
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Age Distribution at Baseline
Periodo de tiempo: Baseline
|
Baseline
|
|
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Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years
Periodo de tiempo: Day 1 to day 387
|
Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. The analyses were performed on the Per-Protocol Set (PPS). |
Day 1 to day 387
|
|
HI GMRs, in 3 to <9 Years and 9 to 17 Years
Periodo de tiempo: Day 1 to day 387
|
Geometric Mean Ratios (GMRs) of hemagglutination inhibition (HI) antibody assay (ratio of post-vaccination versus pre-vaccination HI titers). The analyses were performed on the the per-protocol set (PPS). |
Day 1 to day 387
|
|
HI GMR, in Adults 18 to 64 Years
Periodo de tiempo: Day 1 to day 387
|
Geometric Mean Ratios (GMRs) of hemagglutination inhibition (HI) antibody assay (ratio of post-vaccination versus pre-vaccination HI titers). The analyses were performed on the Per-Protocol Set (PPS). |
Day 1 to day 387
|
|
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years
Periodo de tiempo: 7 days and 21 days after each vaccination
|
Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. The analyses were performed on the per-protocol set (PPS). |
7 days and 21 days after each vaccination
|
|
Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age
Periodo de tiempo: 7 days after each vaccination
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Number of subjects with specified solicited local and systemic reactions in adult subjects (3 to <9 years of age). Postvac: postvaccination; Analges: analgesics; Antipyr: antipyretics. The analyses were performed on the safety set. Note: 1) postvac 1 = after the first vaccination and 2) postvac 2 = after the second vaccination |
7 days after each vaccination
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Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age
Periodo de tiempo: 7 days after each vaccination
|
Number of subjects with specified solicited local and systemic reactions in adult subjects (9 to 17 years of age). Postvac: postvaccination Analges: analgesics Antipyr: antipyretics The analyses were performed on the safety set. Note: 1) postvac 1 = after the first vaccination and 2) postvac 2 = after the second vaccination. |
7 days after each vaccination
|
|
Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age
Periodo de tiempo: 7 days after each vaccination
|
Number of subjects with specified solicited local and systemic reactions in adult subjects (18 to 64 years of age). Note: 1) postvac. 1 = after the first vaccination and 2) postvac. 2 = after the second vaccination. The analyses were performed on the safety set. |
7 days after each vaccination
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Novartis Vaccines, Novartis Vaccines
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
- V112_04
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