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Study of Two Doses of GSK Biologicals' Live Attenuated HRV Vaccine (Two Different Formulations) in Healthy Infants.

15 de septiembre de 2016 actualizado por: GlaxoSmithKline

Phase II, Double-blind, Randomized, Placebo-controlled Study of 2 Doses of GSK Biologicals' Live Attenuated Human Rotavirus Vaccine at Different Virus Concentrations (10 5.2 and 10 6.4 Ffu) in Healthy Infants Following a 0, 2 Month Schedule and Previously Uninfected With Human Rotavirus.

This is a dose exploration study to assess the safety and immunogenicity of two doses of the candidate HRV vaccine at different virus concentrations in the target age group (infants approximately 2 months of age and previously uninfected with human rotavirus) and receiving concomitant administration of routine vaccinations. The study also aims at exploring the effect of unrestricted feeding on the immunogenicity of the vaccine.

Descripción general del estudio

Descripción detallada

All subjects enrolled from Eastern United States and Eastern Canada will continue their participation in the pilot efficacy follow-up (pilot efficacy subset).

The third dose of IPV vaccine (IPOL) may be given at visit 3, 4 or another time, at the investigator's discretion.

Comvax may be given in place of OmniHIB/ActHIB at Visit 1 and Visit 2 and the third dose of Comvax administered according to the prescribing information.

Tipo de estudio

Intervencionista

Inscripción (Actual)

529

Fase

  • Fase 2

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 2 meses (Niño)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • A male or female child between, and including 6 and 12 weeks (42-90 days) of age at the time of the first vaccination.
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study.
  • Written informed consent obtained from the parents or guardians of the subject.
  • Born after a normal gestation period (between 36 and 42 weeks).

Exclusion Criteria:

  • Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the study vaccine or placebo or planned use during the study period.
  • Planned administration of a vaccine (including routine pediatric vaccines) not foreseen by the study protocol during the period starting from 14 days before each dose of vaccine(s) and ending 14 days after. Hepatitis B vaccine given concomitantly or within 14 days before and after vaccination is not an exclusion criteria.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
  • History of diphtheria, tetanus, pertussis, polio, Hib disease and/or invasive pneumococcal infection. History of invasive pneumococcal infection is not an exclusion criteria for Canadian subjects.
  • Previous vaccination against diphtheria, tetanus, pertussis, polio, Haemophilus influenzae type b, and/or Streptococcus pneumoniae. Previous vaccination against Streptococcus pneumoniae is not an exclusion criteria for Canadian subjects.
  • Use of antibiotics within 7 days preceding dose 1.
  • Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the GI tract or other serious medical condition as determined by the investigator.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
  • History of allergic disease or reaction likely to be exacerbated by any component of the vaccine.
  • Acute disease at time of enrollment.
  • Gastroenteritis within 7 days preceding the study vaccine administration.
  • Household contact with an immunosuppressed individual or pregnant women.
  • Administration of immunoglobulins and/or blood products since birth or planned administration during the study period.
  • Previous confirmed occurrence of rotavirus gastroenteritis.
  • Inability to contact parents/guardians of the subject by telephone.

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
Comparador de placebos: Grupo C
Three-dose intramuscular injection (US subjects only)
Two-dose intramuscular injection (US subjects only)
Three-dose intramuscular injection (US subjects only)
Three-dose intramuscular injection (US subjects only)
Otros nombres:
  • ActHIB
Three-dose intramuscular injection (Canada only)
Experimental: Group A
Human Rotavirus Vaccine - Formulation 1
Two oral doses
Three-dose intramuscular injection (US subjects only)
Two-dose intramuscular injection (US subjects only)
Three-dose intramuscular injection (US subjects only)
Three-dose intramuscular injection (US subjects only)
Otros nombres:
  • ActHIB
Three-dose intramuscular injection (Canada only)
Experimental: Group B
Human Rotavirus Vaccine - Formulation 2
Two oral doses
Three-dose intramuscular injection (US subjects only)
Two-dose intramuscular injection (US subjects only)
Three-dose intramuscular injection (US subjects only)
Three-dose intramuscular injection (US subjects only)
Otros nombres:
  • ActHIB
Three-dose intramuscular injection (Canada only)

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Proportion of subjects with vaccine take
Periodo de tiempo: Two months after the second dose
Two months after the second dose
Occurrence of any grade 2 or 3 fever, vomiting or diarrhea
Periodo de tiempo: Within the 15-day solicited follow-up period after any dose of study vaccine.
Within the 15-day solicited follow-up period after any dose of study vaccine.

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Occurrence of each type of solicited symptoms
Periodo de tiempo: Within the 15-day solicited follow-up period after any dose of study vaccine
Within the 15-day solicited follow-up period after any dose of study vaccine
Occurrence of unsolicited symptoms according to WHO classification.
Periodo de tiempo: Within 42 days after dose 1 and dose 2
Within 42 days after dose 1 and dose 2
Occurrence of serious adverse events
Periodo de tiempo: Throughout the entire study period
Throughout the entire study period
Serum rotavirus immunoglobulin A (IgA) antibody titers
Periodo de tiempo: At visits 1, 3 and 4 and at all Visits for pilot efficacy subset
At visits 1, 3 and 4 and at all Visits for pilot efficacy subset
Rotavirus seropositivity status
Periodo de tiempo: Before dose 1 and at the end of the study
Before dose 1 and at the end of the study
Vaccine take (for pilot efficacy subset only)
Periodo de tiempo: 2 months after dose 1
2 months after dose 1
Anti- polyribosyl-ribitol phosphate (PRP), anti-diphtheria and anti-tetanus toxoids, anti- pertussis toxoid (PT), anti- filamentous haemagglutinin (FHA), anti- pertactin (PRN), anti-polio type 1, 2 and 3 antibody concentrations
Periodo de tiempo: Two months after dose 2 and at the end of the study.
Two months after dose 2 and at the end of the study.
Antibody concentrations to pneumococcal serotypes 4, 6B, 9V, 14, 18C, 19F and 23F
Periodo de tiempo: Two months after dose 2 and at the end of the study (only in a subset of U.S. subjects)
Two months after dose 2 and at the end of the study (only in a subset of U.S. subjects)
Anti-PRP, anti-diphtheria, anti-tetanus, anti-polio type 1, 2 and 3 seroprotection status.
Periodo de tiempo: Two months after dose 2 and at the end of the study.
Two months after dose 2 and at the end of the study.
Anti-PT, anti-FHA, anti-PRN, pneumococcal serotypes 4, 6B, 9V, 14, 18C, 19F and 23F (only in US subjects) seropositivity status.
Periodo de tiempo: Two months after dose 2 and at the end of the study.
Two months after dose 2 and at the end of the study.
Seropositivity status and Geometric mean titres (GMTs) of rotavirus IgA for breast fed infants compared with formula fed infants
Periodo de tiempo: Two months after dose 2.
Two months after dose 2.
Occurrence of rotavirus gastroenteritis (in a pilot efficacy subset of subjects)
Periodo de tiempo: Two weeks after dose 2 until the end of the rotavirus season following vaccination.
Two weeks after dose 2 until the end of the rotavirus season following vaccination.

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

1 de noviembre de 2000

Finalización primaria (Actual)

1 de septiembre de 2002

Finalización del estudio (Actual)

1 de septiembre de 2002

Fechas de registro del estudio

Enviado por primera vez

4 de agosto de 2008

Primero enviado que cumplió con los criterios de control de calidad

5 de agosto de 2008

Publicado por primera vez (Estimar)

6 de agosto de 2008

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

16 de septiembre de 2016

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

15 de septiembre de 2016

Última verificación

1 de septiembre de 2016

Más información

Términos relacionados con este estudio

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. Especificación del conjunto de datos
    Identificador de información: 444563/005
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  2. Protocolo de estudio
    Identificador de información: 444563/005
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  3. Conjunto de datos de participantes individuales
    Identificador de información: 444563/005
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  4. Informe de estudio clínico
    Identificador de información: 444563/005
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  5. Formulario de consentimiento informado
    Identificador de información: 444563/005
    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: 444563/005
    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. .

Ensayos clínicos sobre Infecciones, Rotavirus

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