A Study to Evaluate the Safety and Tolerability of Trivalent Influenza Virus Vaccine in Children Aged 5 Years to < 9 Years
20 de septiembre de 2015 actualizado por: Seqirus
A Phase IV, Multicenter, Randomized, Observer-blind, Parallel-arm Study to Evaluate the Safety and Tolerability of CSL's Trivalent Influenza Virus Vaccine (CSL TIV) in Children 5 to Less Than 9 Years of Age.
This is a study to assess the safety of a bioCSL split virion, inactivated Trivalent Influenza Virus vaccine containing the 2014/2015 Northern Hemisphere strains of vaccine in children aged 5 years to less than 9 years.
Comparison will be made to a licensed Quadrivalent Influenza Virus vaccine that complies with the FDA recommendations for the 2014/2015 influenza season in the US.
Descripción general del estudio
Estado
Terminado
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Actual)
402
Fase
- Fase 4
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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California
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Los Angeles, California, Estados Unidos, 90036
- Site 286
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Idaho
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Boise, Idaho, Estados Unidos, 83642
- Site 289
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Missouri
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Saint Louis, Missouri, Estados Unidos, 63141
- Site 287
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New York
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Binghamton, New York, Estados Unidos, 13901
- Site 285
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North Carolina
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Durham, North Carolina, Estados Unidos, 27704
- Site 290
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Raleigh, North Carolina, Estados Unidos, 27609
- Site 281
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Winston-Salem, North Carolina, Estados Unidos, 27103
- Site 280
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29403
- Site 284
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Texas
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Austin, Texas, Estados Unidos, 78705
- Site 283
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Fort Worth, Texas, Estados Unidos, 76135
- Site 282
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San Angelo, Texas, Estados Unidos, 76904
- Site 288
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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
5 años a 8 años (Niño)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Males or females aged 5 to less than 9 years at the time of first study vaccination.
- The subject's parent or guardian to provide written informed consent and be willing and able to adhere to all protocol requirements.
- In good health, as determined by medical history and a targeted physical examination (if warranted).
Exclusion Criteria:
- Known hypersensitivity to a previous dose of Influenza Virus Vaccine or allergy to eggs or any components of the study vaccines.
- Clinical signs of significant active infection or an elevated oral temperature at study entry.
- A clinically significant medical or psychiatric condition.
- A history of seizures or febrile convulsions or Guillain-Barré syndrome.
- Vaccination with a seasonal or experimental influenza virus vaccine in the 6 months preceding study entry.
- Vaccination with a licensed vaccine within 14 days preceding study entry, or planning to be vaccinated with another licensed vaccine before the study exit evaluation.
- Currently receiving systemic glucocorticoid therapy (excluding intra-articular, topical or inhaled preparations) or have received such therapy within the 3 months preceding study entry.
- Currently receiving immunoglobulins and/or any blood products or have received such treatment within the 3 months preceding the administration of the study vaccine.
- Currently receiving treatment with warfarin or other anticoagulants.
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: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)
The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).
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Subjects will receive one or two study vaccinations depending on their influenza vaccine history.
The vaccine will be administered by intramuscular injection.
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Comparador activo: Comparator Quadrivalent Influenza Virus Vaccine
The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.
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Subjects will receive one or two study vaccinations depending on their influenza vaccine history.
The vaccine will be administered by intramuscular injection.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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The Frequency and Intensity of Fever Events Occurring During the 7 Days After Each Administration of CSL TIV Vaccine.
Periodo de tiempo: 7 days after each administration of vaccine.
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The overall percentage of subjects reporting at least one fever event after administration of bioCSL TIV.
A fever event was defined as an oral temperature ≥ 38°C (≥ 100.4°F).
The intensity was calculated as follows: • Mild: ≥ 100.4 to < 101.3°F (≥ 38.0 to < 38.5°C) • Moderate: ≥ 101.3 to < 102.2°F (≥ 38.5 to < 39.0°C) • Severe: ≥ 102.2°F (≥ 39.0°C)
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7 days after each administration of vaccine.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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The Frequency and Intensity of Fever Events Occurring During the 7 Days After Each Administration of the Comparator Influenza Virus Vaccine.
Periodo de tiempo: 7 days after each administration of vaccine.
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The overall percentage of subjects reporting at least one fever event after administration of the comparator influenza virus vaccine.
A fever event was defined as an oral temperature ≥ 38°C (≥ 100.4°F).
The intensity was calculated as follows: • Mild: ≥ 100.4 to < 101.3°F (≥ 38.0 to < 38.5°C) • Moderate: ≥ 101.3 to < 102.2°F (≥ 38.5 to < 39.0°C) • Severe: ≥ 102.2°F (≥ 39.0°C).
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7 days after each administration of vaccine.
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The Frequency and Intensity of Vaccine-related Fever Events Occurring During the 7 Days After Each Administration of CSL TIV Vaccine or Comparator Influenza Virus Vaccine.
Periodo de tiempo: 7 days after each administration of vaccine.
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Percentage of subjects with a related fever event (overall) by study vaccine group based on the number of subjects contributing any follow up safety information for at least one data value of an individual sign/symptom.
Excludes subjects with missing intensity information for the whole 7 days.
Mild fever: ≥ 100.4 to < 101.3º
F (≥ 38.0 to < 38.5º C).
Moderate fever: ≥ 101.3 to < 102.2º
F (≥ 38.5 to < 39.0º C).
Severe fever: ≥ 102.2º
F (≥ 39.0º C).
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7 days after each administration of vaccine.
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The Frequency and Intensity of Solicited Local Adverse Events (AEs) Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Periodo de tiempo: 7 days after each administration of vaccine.
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The overall frequency and intensity of solicited local Adverse Events (AEs) occurring during the 7 days after each administration of bioCSL TIV or the comparator influenza virus vaccine.
Percentage of subjects who experienced each event are based on the number of subjects in the Safety Population group.
Excludes subjects with missing intensity information for the whole 7 days.
Percentages for intensity are based on the number of subjects with non-missing intensity data.
Only the maximum intensity experienced between Day 1 and Day 7 are presented for each subject.
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7 days after each administration of vaccine.
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The Frequency and Intensity of Solicited Systemic AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Periodo de tiempo: 7 days after each administration of vaccine.
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The overall frequency and intensity of solicited systemic Adverse Events (AEs) occurring during the 7 days after each administration of CSL TIV or the comparator influenza virus vaccine.
Percentage of subjects who experienced each event are based on the number of subjects in the Safety Population group.
Excludes subjects with missing intensity information for the whole 7 days.
Percentages for intensity are based on the number of subjects with non-missing intensity data.
Only the maximum intensity experienced between Day 1 and Day 7 are presented for each subject.
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7 days after each administration of vaccine.
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The Frequency and Intensity of Unsolicited AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Periodo de tiempo: 7 days after each administration of vaccine.
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The overall frequency and intensity of unsolicited Adverse Events (AEs) occurring during the 7 days after each administration of CSL TIV or the comparator influenza virus vaccine.
Percentage of subjects who experienced each event are based on the number of subjects in the Safety Population group.
Excludes subjects with missing intensity information for the whole 7 days.
If a subject has multiple events of the same intensity or causality, then they are counted only once in that intensity or causality.
However, subjects can be counted more than once overall.
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7 days after each administration of vaccine.
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The Incidence of Serious Adverse Events (SAEs) Occurring up to 7 Days After the Last Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Periodo de tiempo: 7 days after each administration of vaccine.
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The number of subjects experiencing at least one SAE.
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7 days after each administration of vaccine.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: bioCSL Pty Ltd Clinical Program Director, Seqirus
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 2014
Finalización primaria (Actual)
1 de diciembre de 2014
Finalización del estudio (Actual)
1 de diciembre de 2014
Fechas de registro del estudio
Enviado por primera vez
6 de agosto de 2014
Primero enviado que cumplió con los criterios de control de calidad
7 de agosto de 2014
Publicado por primera vez (Estimar)
8 de agosto de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
16 de octubre de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
20 de septiembre de 2015
Última verificación
1 de septiembre de 2015
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CSLCT-USF-10-69
- 2015-000175-27 (Número EudraCT)
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. .