- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00696423
Immunogenicity and Safety of GSK Biologicals' Infanrix/Hib in Children
27 de abril de 2018 actualizado por: GlaxoSmithKline
Immunogenicity and Reactogenicity Study of GlaxoSmithKline Biologicals' Infanrix™/Hib Vaccine Administered as a Booster Dose to 18-24 Months Old Children
This protocol posting deals with objectives & outcome measures of the booster phase.
The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00412854).
This Phase IIIB study will compare GSK Biologicals' DTPa/Hib vaccine to separately administered DTPa and Hib vaccines in Chinese children 18 to 24 months of age, in terms of safety and immunogenicity.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
467
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
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Mengshan, Porcelana
- GSK Investigational Site
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Wuzhou, Porcelana
- GSK Investigational Site
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Guangxi
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Liucheng County, Guangxi, Porcelana, 545200
- GSK Investigational Site
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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
1 año a 2 años (Niño)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- Subjects should have completed the full three-dose primary vaccination course in study 104567.
- A male or female child between, and including, 18 and 24 months of age at the time of the booster vaccination.
- Written informed consent obtained from the parent or guardian of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding booster vaccination, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the booster dose.
- Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period, with the exception of measles or combined measles, mumps and rubella (MMR) vaccination.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
- Previous booster vaccination against diphtheria, tetanus, pertussis and/or Haemophilus influenzae type b diseases since the end of the primary study.
- History of diphtheria, tetanus, pertussis and/or Haemophilus influenzae type b diseases.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- A family history of congenital or hereditary immunodeficiency.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
- Major congenital defects or serious chronic illness.
- History of any progressive neurological disorders or seizures.
- Acute disease and/or fever at time of enrolment.
- Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
Occurrence of any of the following adverse events (AEs) after previous administration of a diphtheria-tetanus-pertussis (DTP) vaccine:
- Hypersensitivity reaction due to any component of the vaccine.
- Encephalopathy.
- Fever ≥ 40.0 °C (axillary temperature) within 48 hours of vaccination.
- Collapse or shock-like state within 48 hours of vaccination.
- Persistent, inconsolable crying occurring within 48 hours of vaccination and lasting ≥ 3 hours.
- Seizures with or without fever occurring within 3 days of 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 |
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Experimental: Infanrix/Hib Single Injection Group
Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
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Intramuscular injection, one dose
Intramuscular injection, one dose
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Comparador activo: Infanrix + Hiberix Separate Injection Group
Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
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Intramuscular injection, one dose
Intramuscular injection, one dose
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Anti-polyribosyl-ribitol-phosphate (PRP) Antibody Concentrations
Periodo de tiempo: One month after booster vaccination
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Geometric mean concentrations are given in microgram per milliliter (μg/mL).
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One month after booster vaccination
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Anti-diphtheria Toxoid Antibody Concentrations
Periodo de tiempo: One month after booster vaccination
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Geometric mean concentrations are given in international Unit per milliliter (IU/mL).
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One month after booster vaccination
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Anti-tetanus Toxoid Antibody Concentrations
Periodo de tiempo: One month after booster vaccination
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Geometric mean concentrations are given in IU/mL.
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One month after booster vaccination
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Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations
Periodo de tiempo: One month after booster vaccination
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Geometric mean concentrations are given in Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL).
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One month after booster vaccination
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The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies
Periodo de tiempo: One month after booster vaccination
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Assay cut-offs indicating seroprotection or seropositivity for the different antigens were the following: anti-PRP antibody concentrations ≥ 0.15 µg/mL, anti-diphtheria and anti-tetanus antibody concentrations ≥ 0.1 IU/mL, anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 20 EL.U/mL.
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One month after booster vaccination
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Anti-PRP Antibody Concentrations
Periodo de tiempo: Before booster vaccination
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Geometric mean concentrations are given in μg/mL.
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Before booster vaccination
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Anti-diphtheria Toxoid Antibody Concentrations
Periodo de tiempo: Before booster vaccination
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Geometric mean concentrations are given in IU/mL.
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Before booster vaccination
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Anti-tetanus Toxoid Antibody Concentrations
Periodo de tiempo: Before booster vaccination
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Geometric mean concentrations are given in IU/mL.
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Before booster vaccination
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Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Periodo de tiempo: Before booster vaccination
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Geometric mean concentrations are given in EL.U/mL.
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Before booster vaccination
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The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies
Periodo de tiempo: Before booster vaccination
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Assay cut-offs indicating seroprotection or seropositivity for the different antigens were the following: anti-PRP antibody concentrations ≥ 0.15 µg/mL, anti-diphtheria and anti-tetanus antibody concentrations ≥ 0.1 IU/mL, anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 20 EL.U/mL.
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Before booster vaccination
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Number of Subjects Reporting Solicited Local and General Symptoms
Periodo de tiempo: During the 4-day follow-up period after booster vaccination
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Solicited local symptoms assessed include pain, redness and swelling.
Solicited general symptoms assessed include drowsiness, fever, irritability, and loss of appetite.
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During the 4-day follow-up period after booster vaccination
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Number of Subjects Reporting Unsolicited Adverse Events (AE)
Periodo de tiempo: During the 31-day follow-up period after booster vaccination
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An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
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During the 31-day follow-up period after booster vaccination
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Number of Subjects Reporting Serious Adverse Events (SAE)
Periodo de tiempo: During the 31-day follow-up period after booster vaccination
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An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in isability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
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During the 31-day follow-up period after booster vaccination
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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.
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
7 de junio de 2008
Finalización primaria (Actual)
26 de julio de 2008
Finalización del estudio (Actual)
26 de julio de 2008
Fechas de registro del estudio
Enviado por primera vez
5 de junio de 2008
Primero enviado que cumplió con los criterios de control de calidad
10 de junio de 2008
Publicado por primera vez (Estimar)
12 de junio de 2008
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
6 de junio de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
27 de abril de 2018
Última verificación
1 de octubre de 2016
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 111535
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Datos del estudio/Documentos
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Protocolo de estudio
Identificador de información: 111535Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Plan de Análisis Estadístico
Identificador de información: 111535Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Informe de estudio clínico
Identificador de información: 111535Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Formulario de informe de caso anotado
Identificador de información: 111535Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Conjunto de datos de participantes individuales
Identificador de información: 111535Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Especificación del conjunto de datos
Identificador de información: 111535Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Formulario de consentimiento informado
Identificador de información: 111535Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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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