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A Study to Determine the Seroprevalence of Bordetella Pertussis in Adults in Hungary

15 de noviembre de 2019 actualizado por: GlaxoSmithKline

Seroprevalence of Bordetella Pertussis in Adults in Hungary

The purpose of this study is to perform an epidemiological survey of the adult population in Hungary to calculate the seroprevalence of pertussis.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

The protocol posting was amended to correct the detailed title. Since a sample of blood will be collected from all subjects (outside of routine hospital procedure), the study does not meet GSK's definition of an observational study and hence the term "observational" was deleted from the detailed title.

Tipo de estudio

Intervencionista

Inscripción (Actual)

2000

Fase

  • No aplica

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

  • Hungría
      • Budapest, Hungría, 1136
        • GSK Investigational Site
      • Budapest, Hungría, 1182
        • GSK Investigational Site
      • Debrecen, Hungría, 4027
        • GSK Investigational Site
      • Kecskemét, Hungría, 6000
        • GSK Investigational Site
      • Zirc, Hungría, 8420
        • GSK Investigational Site

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

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Subjects who the investigator believes can and will comply with the requirements of the protocol.
  • Written informed consent will be obtained from subjects prior to performing any study procedures.
  • Males or females ≥ 18 years of age at the time of enrollment.
  • Agreeing to collection of a blood sample for the study.

Exclusion Criteria:

• Confirmed or suspected immunological disorder.

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: Otro
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Otro: Study Group
Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample.
Procedimiento: Blood sampling
A blood sample (2.5 mL) will be collected from all subjects
Otro: Data collection
Active questioning

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Seropositive Subjects in Terms of Anti-pertussis Toxin (Anti-PT) Concentrations
Periodo de tiempo: At the time of enrollment of each subject (Day 0)
Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (> 0.3 Optical Density (OD) units)
At the time of enrollment of each subject (Day 0)
Number of Subjects With Anti-PT IgG Levels Strongly Indicative of Current/Recent Infection
Periodo de tiempo: At the time of enrollment of each subject (Day 0)
The cut-off value for anti-PT IgG levels strongly indicative of current/recent infection was greater than or equal to (≥) 1.5 OD units
At the time of enrollment of each subject (Day 0)
Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection
Periodo de tiempo: At the time of enrollment of each subject (Day 0)
The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units.
At the time of enrollment of each subject (Day 0)
Number of Seronegative Subjects in Terms of Anti-PT Concentrations
Periodo de tiempo: At the time of enrollment of each subject (Day 0)
Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units)
At the time of enrollment of each subject (Day 0)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Age)
Periodo de tiempo: At the time of enrollment of each subject (Day 0).
Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (> 0.3 OD units).
At the time of enrollment of each subject (Day 0).
Number of Subjects With Anti-PT IgG Levels Strongly Indicative of Current/Recent Infection (by Age)
Periodo de tiempo: At the time of enrollment of each subject (Day 0)
The cut-off value for anti-PT IgG levels strongly indicative of current/recent infection was greater than or equal to (≥) 1.5 OD units
At the time of enrollment of each subject (Day 0)
Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Age)
Periodo de tiempo: At the time of enrollment of each subject (Day 0)
The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units.
At the time of enrollment of each subject (Day 0)
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Age)
Periodo de tiempo: At the time of enrollment of each subject (Day 0)
Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units)
At the time of enrollment of each subject (Day 0)
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Gender)
Periodo de tiempo: At the time of enrollment of each subject (Day 0)
Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (> 0.3 OD units)
At the time of enrollment of each subject (Day 0)
Number of Subjects With Anti-PT IgG Levels Strongly Indicative of Current/Recent Infection (by Gender)
Periodo de tiempo: At the time of enrollment of each subject (Day 0)
The cut-off value for anti-PT IgG levels strongly indicative of current/recent infection was greater than or equal to (≥) 1.5 OD units
At the time of enrollment of each subject (Day 0)
Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Gender)
Periodo de tiempo: At the time of enrollment of each subject (Day 0)
The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units.
At the time of enrollment of each subject (Day 0)
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Gender)
Periodo de tiempo: At the time of enrollment of each subject (Day 0)
Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units)
At the time of enrollment of each subject (Day 0)
Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Gender)
Periodo de tiempo: At the time of enrollment of each subject (Day 0)
The cut-off value for anti-PT IgG levels not indicative of current/recent infection was smaller than (<) 1.0 OD units.
At the time of enrollment of each subject (Day 0)
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Recent History of Long-lasting Cough)
Periodo de tiempo: At the time of enrollment of each subject (Day 0)
Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (> 0.3 OD units). A long-lasting cough was defined as any cough that lasted for more than (≥) 3 weeks in the previous 12 months.
At the time of enrollment of each subject (Day 0)
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Recent History of Long-lasting Cough)
Periodo de tiempo: At the time of enrollment of each subject (Day 0)
Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units). A long-lasting cough was defined as any cough that lasted for more than (≥) 3 weeks in the previous 12 months.
At the time of enrollment of each subject (Day 0)
Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Recent History of Long-lasting Cough)
Periodo de tiempo: At the time of enrollment of each subject (Day 0)
The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units. A long-lasting cough was defined as any cough that lasted for more than (≥) 3 weeks in the previous 12 months.
At the time of enrollment of each subject (Day 0)
Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Recent History of Long-lasting Cough)
Periodo de tiempo: At the time of enrollment of each subject (Day 0)
The cut-off value for anti-PT IgG levels not indicative of current/recent infection was smaller than (<) 1.0 OD units. A long-lasting cough was defined as any cough that lasted for more than (≥) 3 weeks in the previous 12 months.
At the time of enrollment of each subject (Day 0)
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Smoking Status)
Periodo de tiempo: At the time of enrollment of each subject (Day 0)
Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (> 0.3 OD units)
At the time of enrollment of each subject (Day 0)
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Smoking Status)
Periodo de tiempo: At the time of enrollment of each subject (Day 0)
Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units)
At the time of enrollment of each subject (Day 0)
Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Smoking Status)
Periodo de tiempo: At the time of enrollment of each subject (Day 0)
The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units.
At the time of enrollment of each subject (Day 0)
Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Smoking Status)
Periodo de tiempo: At the time of enrollment of each subject (Day 0)
The cut-off value for anti-PT IgG levels not indicative of current/recent infection was smaller than (<) 1.0 OD units.
At the time of enrollment of each subject (Day 0)
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by History of Pertussis)
Periodo de tiempo: At the time of enrollment of each subject (Day 0)
Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (> 0.3 OD units)
At the time of enrollment of each subject (Day 0)
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by History of Pertussis)
Periodo de tiempo: At the time of enrollment of each subject (Day 0)
Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units)
At the time of enrollment of each subject (Day 0)
Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by History of Pertussis)
Periodo de tiempo: At the time of enrollment of each subject (Day 0)
The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units.
At the time of enrollment of each subject (Day 0)
Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by History of Pertussis)
Periodo de tiempo: At the time of enrollment of each subject (Day 0)
The cut-off value for anti-PT IgG levels not indicative of current/recent infection was smaller than (<) 1.0 OD units.
At the time of enrollment of each subject (Day 0)
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by History of Vaccination Against Pertussis)
Periodo de tiempo: At the time of enrollment of each subject (Day 0)
Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (> 0.3 OD units)
At the time of enrollment of each subject (Day 0)
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by History of Vaccination Against Pertussis)
Periodo de tiempo: At the time of enrollment of each subject (Day 0)
Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units)
At the time of enrollment of each subject (Day 0)
Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by History of Vaccination Against Pertussis)
Periodo de tiempo: At the time of enrollment of each subject (Day 0)
The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units.
At the time of enrollment of each subject (Day 0)
Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by History of Vaccination Against Pertussis)
Periodo de tiempo: At the time of enrollment of each subject (Day 0)
The cut-off value for anti-PT IgG levels indicative of current/recent infection was smaller than (<) 1.0 OD units.
At the time of enrollment of each subject (Day 0)
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Medication)
Periodo de tiempo: At the time of enrollment of each subject (Day 0)
Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (> 0.3 OD units). Medication included any antibiotics and/or other medication (i.e. any cough medicines) for lower respiratory tract infections, Pertussis infections or suspected Pertussis infections in the previous 12 months.
At the time of enrollment of each subject (Day 0)
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Medication)
Periodo de tiempo: At the time of enrollment of each subject (Day 0)
Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units). Medication included any antibiotics and/or other medication (i.e. any cough medicines) for lower respiratory tract infections, Pertussis infections or suspected Pertussis infections in the previous 12 months.
At the time of enrollment of each subject (Day 0)
Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Medication)
Periodo de tiempo: At the time of enrollment of each subject (Day 0)
The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units. Medication included any antibiotics and/or other medication (i.e. any cough medicines) for lower respiratory tract infections, Pertussis infections or suspected Pertussis infections in the previous 12 months.
At the time of enrollment of each subject (Day 0)
Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Medication)
Periodo de tiempo: At the time of enrollment of each subject (Day 0)
The cut-off value for anti-PT IgG levels indicative of current/recent infection was smaller than (<) 1.0 OD units. Medication included any antibiotics and/or other medication (i.e. any cough medicines) for lower respiratory tract infections, Pertussis infections or suspected Pertussis infections in the previous 12 months.
At the time of enrollment of each subject (Day 0)
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Hospitalization)
Periodo de tiempo: At the time of enrollment of each subject (Day 0)
Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (> 0.3 OD units). History of hospitalization was defined as hospitalization due to respiratory infections in the previous 12 months.
At the time of enrollment of each subject (Day 0)
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Hospitalization)
Periodo de tiempo: At the time of enrollment of each subject (Day 0)
Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units). History of hospitalization was defined as hospitalization due to respiratory infections in the previous 12 months.
At the time of enrollment of each subject (Day 0)
Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Hospitalization)
Periodo de tiempo: At the time of enrollment of each subject (Day 0)
The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units. History of hospitalization was defined as hospitalization due to respiratory infections in the previous 12 months.
At the time of enrollment of each subject (Day 0)
Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Hospitalization)
Periodo de tiempo: At the time of enrollment of each subject (Day 0)
The cut-off value for anti-PT IgG levels not indicative of current/recent infection was smaller than (<) 1.0 OD units. History of hospitalization was defined as hospitalization due to respiratory infections in the previous 12 months.
At the time of enrollment of each subject (Day 0)

Colaboradores e Investigadores

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

Patrocinador

GlaxoSmithKline

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 (Actual)

24 de abril de 2014

Finalización primaria (Actual)

22 de abril de 2015

Finalización del estudio (Actual)

24 de abril de 2015

Fechas de registro del estudio

Enviado por primera vez

12 de diciembre de 2013

Primero enviado que cumplió con los criterios de control de calidad

12 de diciembre de 2013

Publicado por primera vez (Estimar)

18 de diciembre de 2013

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

26 de noviembre de 2019

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

15 de noviembre de 2019

Última verificación

1 de noviembre de 2019

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 116804

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

IPD for this study will be made available via the Clinical Study Data Request site.

Marco de tiempo para compartir IPD

IPD is available via the Clinical Study Data Request site (click on the link provided below)

Criterios de acceso compartido de IPD

Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • CIF
  • RSC

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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