Annual Study for Serum Collection for Immunogenicity and Safety Evaluation in Healthy Children Receiving Fluzone®
12 de abril de 2016 actualizado por: Sanofi Pasteur, a Sanofi Company
Annual Study for Serum Collection and Evaluation of Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Influenza Virus Vaccine (2008-2009 Formulation)
Primary Objective:
To provide the Center for Biologics Evaluation and Research (CBER) with sera collected from healthy children receiving the 2008-2009 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study.
Observational Objectives:
To describe the safety of the 2008-2009 pediatric formulation of Fluzone® vaccine, administered in a one- or two-dose schedule in accordance with Advisory Committee on Immunization Practices (ACIP) recommendations, in children ≥ 6 months to < 5 years of age.
To describe the immunogenicity of the 2008-2009 pediatric formulation of Fluzone® vaccine, administered in a one- or two-dose schedule in accordance with ACIP recommendations, in children ≥ 6 months to < 5 years of age.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
The Advisory Committee on Immunization Practices (ACIP) has in recent years recommended that all healthy children aged 6 through 59 months receive influenza vaccine.
Because of the growing emphasis on influenza immunization of infants and young children, Center for Biologics Evaluation and Research (CBER) has expressed interest in receiving sera from children who have been vaccinated with the current formulation of Fluzone® vaccine.
These sera will be tested to evaluate each individual's immune response to the current formulation of Fluzone® vaccine and will also be used to evaluate circulating influenza strains in order to support formulation recommendations for the subsequent year (particularly for influenza B strains, which predominantly affect the young).
Tipo de estudio
Intervencionista
Inscripción (Actual)
32
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
-
-
Virginia
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Norfolk, Virginia, Estados Unidos, 23510
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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
6 meses a 5 años (Niño)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Participant is ≥ 6 months to < 5 years of age.
- Participant is considered to be in good health on the basis of reported medical history and a limited history-directed physical examination.
- Parent/legal acceptable representative is willing and able to bring the subject to the scheduled visits and to comply with the study procedures during the entire duration of the study.
- Parent/legal acceptable representative is willing and able to provide informed consent.
- Subject was born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg (5.5 lbs).
Exclusion Criteria:
- Reported allergy to egg proteins, chicken proteins, or any other constituent of the vaccine.
- History of severe adverse event to any influenza vaccine.
- Laboratory-confirmed influenza infection or vaccination against influenza in the 6 months preceding enrollment in the study.
- Any vaccination scheduled between Visit 1 and Visit 2.
- Planned participation in any other interventional clinical trial during participation in the study.
- Known or suspected impairment of immunologic function or receipt of immunosuppressive therapy or immunoglobulin since birth.
- Personal or immediate family history of congenital immune deficiency.
- Developmental delay, neurologic disorder, or seizure disorder.
- Chronic medical, congenital, or developmental disorder.
- Known Human immunodeficiency virus (HIV)-positive mother.
- Prior personal history of Guillain-Barré syndrome.
- Any condition which, in the opinion of the Investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.
- Thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination.
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: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Group 1: Primed
Have received 2 or more lifetime Flu Vaccinations Prior to Visit 1
|
0.25 mL, IM (age 6-35 months) or 0.5 mL, IM (age 36-59 months)
Otros nombres:
|
|
Experimental: Group 2: Naive/Inadequately Primed
Never Received or Received Only 1 Lifetime Flu Vaccination Prior to Visit 1
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0.25 mL, IM (age 6-35 months) or 0.5 mL, IM (age 36-59 months)
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1
Periodo de tiempo: Day 0 to Day 3 post-vaccination 1
|
Solicited local reactions: Tenderness, pain, erythema, and swelling.
Systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability, headache, malaise, and myalgia.
|
Day 0 to Day 3 post-vaccination 1
|
|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2
Periodo de tiempo: Day 0 to Day 3 post-vaccination 2
|
Solicited local reactions: Tenderness, pain, erythema, and swelling.
Systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability, headache, malaise, and myalgia.
|
Day 0 to Day 3 post-vaccination 2
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination
Periodo de tiempo: Day 28 post-single dose or Day 21 post-Dose 2
|
Day 28 post-single dose or Day 21 post-Dose 2
|
|
|
Percentage of Participants With Influenza Titers ≥ 1:40 After Fluzone® Vaccination (Seroprotection)
Periodo de tiempo: Day 28 post-single dose or Day 21 post-Dose 2
|
Seroprotection was defined as a post-vaccination Hemagglutination inhibition titer ≥ 1:40.
Data presented for all participants and those enrolled at age 6 to 35 months.
|
Day 28 post-single dose or Day 21 post-Dose 2
|
|
Percentage of Participants With Influenza Titers ≥ 1:40 After Fluzone® Vaccination (Seroprotection)
Periodo de tiempo: Day 28 post-single dose or Day 21 post-Dose 2
|
Seroprotection was defined as a post-vaccination Hemagglutination inhibition titer ≥ 1:40.
Data presented for participants enrolled at age 36 to 59 months.
|
Day 28 post-single dose or Day 21 post-Dose 2
|
|
Percentage of Participants With at Least a 4-Fold Rise in Influenza Titers After Fluzone® Vaccination (Seroconversion)
Periodo de tiempo: Day 28 post-single dose or Day 21 post-Dose 2
|
Seroconversion was defined as a ≥ 4-fold increase in post-vaccination Hemagglutination inhibition titer.
Data presented for all participants and those enrolled at age 6 to 35 months of age.
|
Day 28 post-single dose or Day 21 post-Dose 2
|
|
Percentage of Participants With at Least a 4-Fold Rise in Influenza Titers After Fluzone® Vaccination (Seroconversion)
Periodo de tiempo: Day 28 post-single dose or Day 21 post-Dose 2
|
Seroconversion was defined as a ≥ 4-fold increase in post-vaccination Hemagglutination inhibition titer.
Data presented for participants enrolled at age 36 to 59 months.
|
Day 28 post-single dose or Day 21 post-Dose 2
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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.
Enlaces Útiles
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 2008
Finalización primaria (Actual)
1 de enero de 2009
Finalización del estudio (Actual)
1 de enero de 2009
Fechas de registro del estudio
Enviado por primera vez
16 de septiembre de 2008
Primero enviado que cumplió con los criterios de control de calidad
16 de septiembre de 2008
Publicado por primera vez (Estimar)
18 de septiembre de 2008
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
14 de abril de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
12 de abril de 2016
Última verificación
1 de abril de 2016
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- GRC40
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. .