- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00729001
Study of Two Doses of GSK Biologicals' Live Attenuated HRV Vaccine (Two Different Formulations) in Healthy Infants.
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.
Descripción general del estudio
Estado
Condiciones
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
Inscripción (Actual)
Fase
- Fase 2
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
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
¿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:
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:
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:
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
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Dennehy PH; North American Human Rotavirus Vaccine Study Group. A short report on the highlights of world-wide development of RIX4414: a North American experience comparative evaluation of safety and immunogenicity of two dosages of an oral live attenuated human rotavirus vaccine (RIX4414) in infants in the United States and Canada. Vaccine. 2006 May 1;24(18):3780-1. doi: 10.1016/j.vaccine.2005.07.030. Epub 2005 Aug 1.
- Dennehy PH, Brady RC, Halperin SA, Ward RL, Alvey JC, Fischer FH Jr, Innis BL, Rathfon H, Schuind A, De Vos B; North American Human Rotavirus Vaccine Study Group. Comparative evaluation of safety and immunogenicity of two dosages of an oral live attenuated human rotavirus vaccine. Pediatr Infect Dis J. 2005 Jun;24(6):481-8. doi: 10.1097/01.inf.0000164763.55558.71.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 444563/005
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Datos del estudio/Documentos
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Especificación del conjunto de datos
Identificador de información: 444563/005Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Protocolo de estudio
Identificador de información: 444563/005Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
-
Conjunto de datos de participantes individuales
Identificador de información: 444563/005Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
-
Informe de estudio clínico
Identificador de información: 444563/005Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
-
Formulario de consentimiento informado
Identificador de información: 444563/005Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
-
Plan de Análisis Estadístico
Identificador de información: 444563/005Comentarios 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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