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Safety and Immunogenicity of a Booster Dose of GSK Biological's Boostrix-Polio Vaccine

27 de abril de 2018 actualizado por: GlaxoSmithKline

Evaluation of GSK Biological's dTpa-IPV Booster Vaccine in Children and Adolescents, 5 Years After Previous dTpa-IPV Boosting.

Subjects aged 9 to 13 years who participated in the 711866/001 study 5 years ago will be evaluated for immune persistence and will receive a combined dTpa-IPV booster dose that will be evaluated in terms of immunogenicity, safety and reactogenicity.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

415

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

  • Alemania
      • Berlin, Alemania, 12627
        • GSK Investigational Site
      • Berlin, Alemania, 13507
        • GSK Investigational Site
      • Berlin, Alemania, 13355
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • Ettenheim, Baden-Wuerttemberg, Alemania, 77955
        • GSK Investigational Site
      • Kehl, Baden-Wuerttemberg, Alemania, 77694
        • GSK Investigational Site
      • Oberkirch, Baden-Wuerttemberg, Alemania, 77704
        • GSK Investigational Site
      • Offenburg, Baden-Wuerttemberg, Alemania, 77654
        • GSK Investigational Site
    • Bayern
      • Cham, Bayern, Alemania, 93413
        • GSK Investigational Site
      • Kaufering, Bayern, Alemania, 86916
        • GSK Investigational Site
      • Landshut, Bayern, Alemania, 84032
        • GSK Investigational Site
      • Muenchen, Bayern, Alemania, 80939
        • GSK Investigational Site
      • Olching, Bayern, Alemania, 82140
        • GSK Investigational Site
      • Weilheim, Bayern, Alemania, 82362
        • GSK Investigational Site
    • Hessen
      • Eschwege, Hessen, Alemania, 37269
        • GSK Investigational Site
      • Koenigstein, Hessen, Alemania, 61462
        • GSK Investigational Site
    • Niedersachsen
      • Salzgitter, Niedersachsen, Alemania, 38226
        • GSK Investigational Site
      • Wolfenbuettel, Niedersachsen, Alemania, 38302
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Erkrath, Nordrhein-Westfalen, Alemania, 40699
        • GSK Investigational Site
      • Goch, Nordrhein-Westfalen, Alemania, 47574
        • GSK Investigational Site
      • Guetersloh, Nordrhein-Westfalen, Alemania, 33332
        • GSK Investigational Site
      • Heiligenhaus, Nordrhein-Westfalen, Alemania, 42579
        • GSK Investigational Site
      • Kleve-Materborn, Nordrhein-Westfalen, Alemania, 47533
        • GSK Investigational Site
      • Krefeld, Nordrhein-Westfalen, Alemania, 47798
        • GSK Investigational Site
      • Loehne, Nordrhein-Westfalen, Alemania, 32584
        • GSK Investigational Site
      • Muenster, Nordrhein-Westfalen, Alemania, 48159
        • GSK Investigational Site
      • Willich, Nordrhein-Westfalen, Alemania, 47877
        • GSK Investigational Site
    • Rheinland-Pfalz
      • Bad Kreuznach, Rheinland-Pfalz, Alemania, 55543
        • GSK Investigational Site
      • Frankenthal, Rheinland-Pfalz, Alemania, 67227
        • GSK Investigational Site
      • Mainz, Rheinland-Pfalz, Alemania, 55131
        • GSK Investigational Site
      • Trier, Rheinland-Pfalz, Alemania, 54294
        • GSK Investigational Site
      • Worms, Rheinland-Pfalz, Alemania, 67547
        • GSK Investigational Site
      • Worms, Rheinland-Pfalz, Alemania, 67549
        • GSK Investigational Site
    • Sachsen
      • Dresden, Sachsen, Alemania, 01307
        • GSK Investigational Site
      • Dresden, Sachsen, Alemania, 01169
        • GSK Investigational Site
    • Schleswig-Holstein
      • Brunsbuettel, Schleswig-Holstein, Alemania, 25541
        • GSK Investigational Site
      • Flensburg, Schleswig-Holstein, Alemania, 24937
        • GSK Investigational Site
      • Flensburg, Schleswig-Holstein, Alemania, 24939
        • GSK Investigational Site
      • Flensburg, Schleswig-Holstein, Alemania, 24943
        • 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

9 años a 13 años (Niño)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Subjects who the investigator believes that they or their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
  • A male or female subject who received a booster vaccination with dTpa-IPV or dTpa + IPV in study 711866/001.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Females of childbearing potential at the time of study entry must have a negative pregnancy test prior to administration of the dose of vaccine and are required to be abstinent or to use adequate contraceptive precautions for one month prior to vaccination. Subjects are required to agree to continue such precautions for two months after vaccination.
  • Written informed consent obtained from both parents/ guardians of the subject; assent from the subject himself/herself should also be requested whenever possible.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
  • Chronic administration (defined as more than 14 days) of immunosuppressant 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 study period.
  • 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 tetanus, diphtheria, pertussis, or poliomyelitis since the booster dose received in study 711866/001.
  • History of diphtheria, tetanus, pertussis, or poliomyelitis diseases.
  • Any confirmed or suspected immunosuppressive or immunodeficiency condition, based on medical history and physical examination.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Administration of immunoglobulin and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
  • Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus.
  • Occurrence of any of the following adverse events (AEs) after a previous administration of a DTP vaccine: hypersensitivity reaction to any component of the vaccine, encephalopathy of unknown aetiology occurring within 7 days following previous vaccination with pertussis-containing vaccine, fever ≥ 40°C within 48 hours of vaccination not due to another identifiable cause, collapse or shock-like state within 48 hours of vaccination
  • Persistent, severe, inconsolable screaming or crying lasting >3 hours occurring within 48 hours of receipt of a previous dose of DTP vaccine convulsions with or without fever, occurring within 3 days of vaccination.
  • Acute disease at the time of enrolment.
  • Pregnant or lactating female.

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: BOOSTRIX-POLIO GROUP
Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
Biológico: Boostrix-Polio
A single booster dose of dTpa-IPV vaccine will be administered to all subjects. IM administration in the deltoid muscle of the non-dominant arm.
Experimental: BOOSTRIX + IPV MÉRIEUX GROUP
Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™ and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
Biológico: Boostrix-Polio
A single booster dose of dTpa-IPV vaccine will be administered to all subjects. IM administration in the deltoid muscle of the non-dominant arm.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Subjects With Any Grade 3 Solicited Local Symptoms
Periodo de tiempo: During the 4-day (Days 0-3) follow-up period after booster vaccination
Assessed solicited local symptoms were pain, redness and swelling. Grade 3 Pain: Pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
During the 4-day (Days 0-3) follow-up period after booster vaccination

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Número de sujetos con cualquier síntoma local solicitado
Periodo de tiempo: Durante el período de seguimiento de 4 días (Días 0-3) después de la vacunación de refuerzo
Los síntomas locales solicitados evaluados fueron dolor, enrojecimiento e hinchazón. Cualquiera = aparición del síntoma independientemente del grado de intensidad.
Durante el período de seguimiento de 4 días (Días 0-3) después de la vacunación de refuerzo
Number of Subjects With Any Solicited General Symptoms
Periodo de tiempo: During the 4-day (Days 0-3) follow-up period after booster vaccination
Assessed solicited general symptoms were fatigue, gastrointestinal, headache and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade and relationship to vaccination.
During the 4-day (Days 0-3) follow-up period after booster vaccination
Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Toxoids
Periodo de tiempo: Prior to (Month 0) and one month after (Month 1) booster vaccination
Anti-D and anti-T antibody concnetration greater than or equal to (≥) 0.1 international units per milliliter (IU/mL) and ≥ 1 IU/mL have been assessed by enzyme-linked immunosorbent assay (ELISA). Pre-vaccination sera with ELISA concentrations < 0.1 IU/mL were tested for neutralising antibodies using a Vero-cell neutralisation assay with a 0.016 IU/mL cut-off.
Prior to (Month 0) and one month after (Month 1) booster vaccination
Anti-D and Anti-T Antibody Concentrations
Periodo de tiempo: Prior to (Month 0) and one month after (Month 1) booster vaccination
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).
Prior to (Month 0) and one month after (Month 1) booster vaccination
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)
Periodo de tiempo: Prior to (Month 0) and one month after (Month 1) booster vaccination
A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 ELISA unit per milliliter (EL.U/ml).
Prior to (Month 0) and one month after (Month 1) booster vaccination
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Periodo de tiempo: Prior to (Month 0) and one month after (Month 1) booster vaccination
Antibodies concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.
Prior to (Month 0) and one month after (Month 1) booster vaccination
Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens
Periodo de tiempo: Prior to (Month 0) and one month after (Month 1) booster vaccination
A seroprotected subject was defined as a subject with anti-Polio type 1, 2 and 3 antibody titers ≥ the value of 8.
Prior to (Month 0) and one month after (Month 1) booster vaccination
Anti-Polio 1, 2 and 3 Antibody Titers
Periodo de tiempo: Prior to (Month 0) and one month after (Month 1) booster vaccination
Antibody titers were presented as geometric mean titers (GMTs).
Prior to (Month 0) and one month after (Month 1) booster vaccination
Number of Subjects With Booster Response to Anti-PT, Anti-FHA and Anti-PRN
Periodo de tiempo: One month after booster vaccination (At Month 1)
Booster vaccine response was defined as appearance of antibodies in subjects who were seronegative at the pre-vaccination time point (i.e. with concentrations < 5 EL.U/mL) or at least 2-fold increase of pre-vaccination antibody concentrations in subjects who were seropositive at the pre-vaccination time point (i.e. with concentrations < 5 EL.U/mL).
One month after booster vaccination (At Month 1)
Number of Subjects With Unsolicited Adverse Events (AEs)
Periodo de tiempo: During the 31-day (Days 0-30) follow-up period after booster vaccination
AEs results are presented for all subjects. An unsolicited AE covers 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 and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
During the 31-day (Days 0-30) follow-up period after booster vaccination
Number of Subjects With Serious Adverse Events (SAEs)
Periodo de tiempo: During the entire booster period (Month 0 to Month 1)
Assessed SAEs include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
During the entire booster period (Month 0 to Month 1)

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

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 (Actual)

1 de febrero de 2008

Finalización primaria (Actual)

8 de julio de 2008

Finalización del estudio (Actual)

8 de julio de 2008

Fechas de registro del estudio

Enviado por primera vez

6 de marzo de 2008

Primero enviado que cumplió con los criterios de control de calidad

6 de marzo de 2008

Publicado por primera vez (Estimar)

13 de marzo 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 abril de 2017

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 110947

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

  1. Especificación del conjunto de datos
    Identificador de información: 110947
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  2. Informe de estudio clínico
    Identificador de información: 110947
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  3. Formulario de consentimiento informado
    Identificador de información: 110947
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  4. Conjunto de datos de participantes individuales
    Identificador de información: 110947
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  5. Protocolo de estudio
    Identificador de información: 110947
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  6. Plan de Análisis Estadístico
    Identificador de información: 110947
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  7. Formulario de informe de caso anotado
    Identificador de información: 110947
    Comentarios 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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