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A Study to Explore the Existence of Horizontal Transmission of the RIX4414 Vaccine Strain Between Twins Within a Family.

9 de enero de 2018 actualizado por: GlaxoSmithKline

A Phase IIIb, Randomized, Double-Blind, Placebo-Controlled Study to Explore the Existence of Horizontal Transmission of the RIX4414 Vaccine Strain Between Twins Within a Family.

The aim of this study is to explore horizontal transmission of the HRV (Human Rotavirus) vaccine strain within a family from the twin vaccinated with Rotarix to the twin receiving placebo. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Descripción general del estudio

Estado

Terminado

Descripción detallada

This is a Phase 3b study. Three doses of Infanrix® hexa will be administered to all subjects at the discretion of the investigator.

One complimentary dose of Rotarix will be administered to all infants enrolled in this study (both study groups) who are aged less than 6 months at Visit 3 (Week 13) as a benefit to the placebo group for participation in the study.

The study will be conducted in a double-blind manner with respect to Rotarix and placebo administered at Visit 1 and Visit 2. The parents/guardians of the subjects will know that within each pair of twins, one subject will receive the Rotarix vaccine and one subject will receive the placebo.

The study will be open label with respect to administration of the Rotarix vaccine dose given at Visit 3 to all subjects in each group who are aged less than 6 months.

Tipo de estudio

Intervencionista

Inscripción (Actual)

200

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

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 mes a 3 meses (Niño)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Subjects with a live twin living in the same household who is also enrolled in this study.
  • Born after a gestation period of ≥32 weeks,
  • Discharged from hospital neonatal care stay,
  • 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.
  • A male or female between, and including, 6 and 14 weeks of age at the time of the first study vaccination.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Written informed consent obtained from the parent or guardian of the subjects.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
  • Any clinically significant history of chronic gastrointestinal disease.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Acute disease at time of enrolment.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
  • Contact with an immunosuppressed individual.
  • 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 (pharmaceutical product or device).
  • Chronic administration of immunosuppressants since birth.
  • Gastroenteritis within 7 days preceding the first study vaccine administration.
  • Documented HIV-positive subject.

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: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Rotarix Group

All subjects received 2 oral doses of Rotarix vaccine at Day 0 (Visit 1) and Week 7 (Visit 2).

Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3).

Two-dose oral vaccination.
Comparador de placebos: Placebo Group

All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2).

Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3).

Two-dose oral vaccination.
Two-dose oral administration.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Presence of Rotavirus Vaccine Strain in Any Stool Sample From Twin Receiving Placebo.
Periodo de tiempo: On the day of each vaccine/placebo dose, then three times weekly for 6 consecutive weeks starting after each vaccine/placebo dose and on the day of Visit 3.
Number of subjects in the Placebo Group with rotavirus vaccine strain in at least one stool sample.
On the day of each vaccine/placebo dose, then three times weekly for 6 consecutive weeks starting after each vaccine/placebo dose and on the day of Visit 3.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Duration of Human Rotavirus (HRV) Shedding Per Study Group.
Periodo de tiempo: From Day 0 up to Week 13.
Duration of shedding in the Placebo Group= number of days between first and last stool sample positive (+) for rotavirus (RV) antigen and in the Rotarix Group= number of days between the day of vaccination and the date of last stool sample + for RV antigen.
From Day 0 up to Week 13.
Number of Genetic Variation Differences Detected by Sequencing of Genomic Mutations in the HRV Vaccine Strain After Transmission.
Periodo de tiempo: During the entire study period (up to Visit 4, Week 17).
Dissimilar amino acid substitutions in the HRV vaccine strain isolated from the twin receiving placebo, when compared to the genetic variation of HRV vaccine strain isolated from the Rotarix vaccine recipients, were counted as genetic variation differences.
During the entire study period (up to Visit 4, Week 17).
Live Viral Vaccine Load in the Stool of the Twin Receiving Placebo in Case of Transmission.
Periodo de tiempo: During the entire study period (up to Visit 4, Week 17).
Number of subjects in the Placebo Group with live virus identified in at least one stool sample in case of transmission.
During the entire study period (up to Visit 4, Week 17).
Anti-rotavirus Immunoglobulin A (IgA) Antibody Seroconversion.
Periodo de tiempo: At Visit 3 (Week 13).
Number of initially seronegative subjects with anti-rotavirus IgA antibody concentration ≥ 20 Units/milliliter (U/mL), 1 month after the second dose.
At Visit 3 (Week 13).
Anti-rotavirus IgA Antibody Concentration.
Periodo de tiempo: At Visit 3 (Week 13).
Anti-rotavirus IgA antibody concentrations are given as geometric mean concentrations (GMC) with 95% Confidence Intervals.
At Visit 3 (Week 13).
Number of Subjects With Gastroenteritis (GE) and Rotavirus Gastroenteritis (RV GE) Episodes.
Periodo de tiempo: Until Visit 4 (Week 17) for GE and until Visit 3 (Week 13) for RV GE.

GE episodes were defined as diarrhea (passage of three or more looser than normal stools within a day) with or without vomiting.

RV GE episodes were defined as GE episodes for which the stool sample temporally closest to the onset day of the GE episode was positive for rotavirus by Enzyme Linked Immunosorbent Assay (ELISA).

Until Visit 4 (Week 17) for GE and until Visit 3 (Week 13) for RV GE.
Number of Subjects Reporting Unsolicited Adverse Events (AEs).
Periodo de tiempo: Within 31 days after any doses.
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.
Within 31 days after any doses.
Number of Subjects Reporting Any Serious Adverse Events (SAEs).
Periodo de tiempo: Up to Visit 4.

A serious adverse event (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.

Up to Visit 4.

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 (Actual)

23 de enero de 2007

Finalización primaria (Actual)

23 de enero de 2008

Finalización del estudio (Actual)

13 de febrero de 2008

Fechas de registro del estudio

Enviado por primera vez

6 de noviembre de 2006

Primero enviado que cumplió con los criterios de control de calidad

6 de noviembre de 2006

Publicado por primera vez (Estimar)

7 de noviembre de 2006

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

6 de febrero de 2018

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

9 de enero de 2018

Última verificación

1 de noviembre de 2017

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 106260

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

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. Formulario de consentimiento informado
    Identificador de información: 106260
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  2. Especificación del conjunto de datos
    Identificador de información: 106260
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  3. Protocolo de estudio
    Identificador de información: 106260
    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: 106260
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  5. Plan de Análisis Estadístico
    Identificador de información: 106260
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  6. Informe de estudio clínico
    Identificador de información: 106260
    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: 106260
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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. .

Ensayos clínicos sobre Infecciones, Rotavirus

Ensayos clínicos sobre Rotarix

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