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Long-Term Immune Persistence of GlaxoSmithKline Biologicals' Inactivated Hepatitis A Vaccine Injected According to a 0, 12-month Schedule

23 de octubre de 2017 actualizado por: GlaxoSmithKline

Double-blind Randomized Study to Evaluate the Immunogenicity and Reactogenicity of Two Different Lots of GlaxoSmithKline Biologicals' Inactivated Hepatitis A Vaccine Containing 1440 EL.U of Antigen Per mL and Injected According to a 0, 12 Month Schedule in Healthy Adult Volunteers

The aim of this study is to evaluate the persistence of hepatitis A antibodies at 138, 150, 162, 174,186, 198, 210, 222, 234 and 246 months after subjects received their first dose of a 2 dose vaccination schedule of hepatitis A vaccine.

This protocol posting deals with objectives & outcome measures of the extension phase at year 11 to 20.

No additional subjects will be recruited during this long-term follow-up.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

This is a long-term follow-up study at Years 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 after primary vaccination with GSK Biologicals' hepatitis A vaccine (two-dose schedule). To evaluate the long-term antibody persistence, volunteers will donate a blood sample at Years 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 after the first vaccine dose of the primary vaccination course to determine their anti-hepatitis A (anti-HAV) antibody concentrations.

If a subject has become seronegative for anti-HAV antibodies during any of the long-term blood sampling time point (i.e. Months 138, 150, 162, 174,186, 198, 210, 222, 234 and 246), he/ she will be offered an additional vaccine dose. A blood sample will be taken on the day of the additional vaccination 14 days and one month after additional vaccination to evaluate the immune response following this vaccination.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007 and to extend the follow up until Year 20.

The study has 10 phases: 100571, 100572, 100573, 100574, 100575, 110677, 110678, 110679, 110680, 110681.

Tipo de estudio

Intervencionista

Inscripción (Actual)

135

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

  • Bélgica
      • Wilrijk, Bélgica, 2610
        • 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

29 años a 60 años (Adulto)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Subjects who had received at least one dose of the study vaccine in the primary study
  • Written informed consent will have been obtained from the subjects before the blood sampling visit of each year.

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

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Havrix Group
Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
Biológico: Havrix™
2 doses at 12 months interval

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration
Periodo de tiempo: At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246
Concentrations given as geometric mean concentration (GMC) expressed as milli-international unit per millilitre (mIU/mL). ** = Regarding Month 234 data, please note that there were 5 subjects for whom serum sample tube was broken and thus due to risk of contamination the test were not performed. Hence these subjects were not included in the LT-ATP cohort for immunogenicity analysis at Month 234. $ = Regarding Month 246 data, please note there was 1 subject for whom serum sample tube was broken and hence scrapped by laboratory. Hence this subject was not included in the LT-ATP cohort for immunogenicity analysis at Month 246.
At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246
Number of Seropositive Subjects Against Hepatitis A Virus
Periodo de tiempo: At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246
A seropositive subject was a vaccinated subject whose concentrations for antibodies against hepatitis A virus (anti-HAV) were equal or above (>=) the assay cut-off for seropositivity of 15 milli-international units per milliliter (mIU/mL). ** = Regarding Month 234 data, please note that there were 5 subjects for whom serum sample tube was broken and thus due to risk of contamination the test were not performed. Hence these subjects were not included in the LT-ATP cohort for immunogenicity analysis at Month 234. $ = Regarding Month 246 data, please note there was 1 subject for whom serum sample tube was broken and hence scrapped by laboratory. Hence this subject was not included in the LT-ATP cohort for immunogenicity analysis at Month 246.
At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration
Periodo de tiempo: Before additional vaccination, 14 days after additional vaccination and 30 days after additional vaccination

Concentrations given as GMC expressed as mIU/mL. 4 subjects received additional vaccination at Month 186 and 1 subject at Month 198.

Please note that value 14.9 means <15.
Before additional vaccination, 14 days after additional vaccination and 30 days after additional vaccination
Number of Subjects Reporting Solicited Local Symptoms
Periodo de tiempo: During the 4-day (Days 0-3) follow-up period after additional vaccination
Solicited local symptoms assessed include pain, redness and swelling. Additional vaccination was given to 4 subjects at the Month 186 timepoint and to 1 subject at the Month 198 timepoint.
During the 4-day (Days 0-3) follow-up period after additional vaccination
Number of Subjects Reporting Solicited General Symptoms
Periodo de tiempo: During the 4-day (Days 0-3) follow-up period after additional vaccination

Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms and headache.

4 subjects received additional vaccination at Month 186 and 1 subject at Month 198.
During the 4-day (Days 0-3) follow-up period after additional vaccination
Number of Subjects Reporting Unsolicited Adverse Events (AE)
Periodo de tiempo: During the 30-day follow-up period after additional vaccination

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.

4 subjects received additional vaccination at Month 186 and 1 at Month 198.
During the 30-day follow-up period after additional vaccination
Number of Subjects Reporting Serious Adverse Events (SAE) Assessed by the Investigator as Related to Primary Study Vaccination, Procedures or Lack of Vaccine Efficacy
Periodo de tiempo: At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246
An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above
At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246
Number of Subjects Reporting Serious Adverse Events (SAE) After Additional Vaccination
Periodo de tiempo: During the 30-day follow-up period after additional vaccination

An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.

4 subjects received additional vaccination at Month 186 and 1 at Month 198.
During the 30-day follow-up period after additional vaccination
Number of Subjects Reporting Pregnancies After Additional Vaccination
Periodo de tiempo: At Months 186 and 198
The number of subjects with outcome of pregnancies reported among subjects who had received the additional vaccination was tabulated. 4 subjects received additional vaccination at Month 186 and 1 subject at Month 198.
At Months 186 and 198

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

1 de enero de 2004

Finalización primaria (Actual)

1 de marzo de 2013

Finalización del estudio (Actual)

1 de marzo de 2013

Fechas de registro del estudio

Enviado por primera vez

14 de febrero de 2006

Primero enviado que cumplió con los criterios de control de calidad

14 de febrero de 2006

Publicado por primera vez (Estimar)

15 de febrero de 2006

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

29 de noviembre de 2017

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

23 de octubre de 2017

Última verificación

1 de enero de 2017

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 100571 (M138)
  • 100572 (M150) (Otro identificador: GSK)
  • 100573 (M162) (Otro identificador: GSK)
  • 100574 (M174) (Otro identificador: GSK)
  • 100575 (M186) (Otro identificador: GSK)
  • 110677 (M198) (Otro identificador: GSK)
  • 110678 (M210) (Otro identificador: GSK)
  • 110679 (Otro identificador: GSK)
  • 110680 (Otro identificador: GSK)
  • 110681 (Otro identificador: GSK)

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. Conjunto de datos de participantes individuales
    Identificador de información: 100571 (M138)
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 100571 are summarised with studies 100572, 100573, 100574, 100575, 110677, 110678, 110679, 110680, and 110681 on the GSK Clinical Study
  2. Formulario de consentimiento informado
    Identificador de información: 100571 (M138)
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  3. Protocolo de estudio
    Identificador de información: 100571 (M138)
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  4. Especificación del conjunto de datos
    Identificador de información: 100571 (M138)
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  5. Informe de estudio clínico
    Identificador de información: 100571 (M138)
    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: 100571 (M138)
    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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