- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01825109
Improving Rotavirus Vaccine Immune Response
Improving the Immune Response to Rotavirus Vaccine
Descripción general del estudio
Estado
Condiciones
Descripción detallada
The study will be conducted in a suburb of Dhaka in the area of Mirpur. Mirpur is one of the 14 Thanas of Dhaka cities with a population of about one million in an area of 59 square kilometers. Mirpur Thana of Dhaka city is divided into several sections. There are 14 sections in Mirpur Thana. The area is densely populated and located 20 minutes away from the lCDDR,B's Dhaka Hospital . The population is stable with low socioeconomic conditions. The average income in the slum areas of Mirpur is Tk.4200 (about US $ 62) per month per family. 25% of fathers and 15% of mothers have more than 5 years of formal education. The study will be conducted in section 11 and 12 of Mirpur which has a population of about 500,000. We recently conducted phase I and II of the rotavirus vaccine study in this site. Several other studies (phase II ETEC, killed cholera vaccine) are ongoing in this area. Children will be identified through active surveillance of new births in the community and the study subjects will be recruited through home visits by the locally recruited field workers.
2.2 .Design : Randomized intervention trial
Study groups:
- Administration of Rotarix at 6 and 10 weeks co-administered with oral polio virus vaccine with no intervention in normal breastfeeding practices before and after receiving vaccine.
- Administration of Rotarix at 6 and 10 weeks co-administered with oral polio virus. Breastfeeding will not be permitted 45 minutes prior to vaccine administration and 45 minutes after each vaccine administration.
- Administration of Rotarix at 14 and 18 weeks co-administered with oral polio virus, with no intervention in normal breastfeeding practices before and after receiving vaccine.
- Administration of Rotarix at 14 and 18 weeks co-administered with oral polio virus. Breastfeeding will not be permitted 45 minutes prior to vaccine administration and 45 minutes after each vaccine administration.
Samples collected:
- Blood draw at the time of first dose of Rotavirus vaccine and 4 weeks after the second dose
- Breast milk sample at 6 weeks for the mothers in study groups A and B, and at 14 weeks for mothers in study groups C and D (see below for groups).
- Stool sample prior to dose one and on day 3 and 7 after each dose to look for vaccine virus shedding
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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Dhaka, Bangladesh, 1216
- Mirpur
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- male or female,
- aged 6 weeks at the time of enrollment,
- written informed consent,
- free of chronic or serious medical condition as determined by history and physical exam and plan to stay in community for at least 6 months
Exclusion Criteria:
- fever (>38 C),
- acute or chronic illness,
- use of antimicrobial drug within previous 14 days,
- hypersensitivity to any of the vaccine components (see vaccine composition),
- use of any investigational drug during previous 30 days,
- any uncorrected congenital malformation of the gastrointestinal tract,
- use of any immunosuppressing drugs during the last 14 days (likelihood is remote),
- any evidence by physical exam of immunosuppresing condition,
- administration of gamma globulin or any other blood product,
- previous intussusception or abdominal surgery.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: 6 weeks RV & normal breast feeding
Administration of Rotarix at 6 and 10 weeks co-administered with oral polio virus vaccine with no intervention in normal breastfeeding practices before and after receiving vaccine.
|
Administration of Rotarix at 6 and 10 weeks co-administered with oral polio virus vaccine with no intervention in normal breastfeeding practices before and after receiving vaccine.
Administration of Rotarix at 6 and 10 weeks co-administered with oral polio virus.
Breastfeeding will not be permitted 45 minutes prior to vaccine administration and 45 minutes after each vaccine administration.
Administration of Rotarix at 14 and 18 weeks co-administered with oral polio virus, with no intervention in normal breastfeeding practices before and after receiving vaccine.
Administration of Rotarix at 14 and 18 weeks co-administered with oral polio virus.
Breastfeeding will not be permitted 45 minutes prior to vaccine administration and 45 minutes after each vaccine administration.
|
Experimental: 6 weeks RV & delayed breastfeeding
Administration of Rotarix at 6 and 10 weeks co-administered with oral polio virus.
Breastfeeding will not be permitted 45 minutes prior to vaccine administration and 45 minutes after each vaccine administration.
|
Administration of Rotarix at 6 and 10 weeks co-administered with oral polio virus vaccine with no intervention in normal breastfeeding practices before and after receiving vaccine.
Administration of Rotarix at 6 and 10 weeks co-administered with oral polio virus.
Breastfeeding will not be permitted 45 minutes prior to vaccine administration and 45 minutes after each vaccine administration.
Administration of Rotarix at 14 and 18 weeks co-administered with oral polio virus, with no intervention in normal breastfeeding practices before and after receiving vaccine.
Administration of Rotarix at 14 and 18 weeks co-administered with oral polio virus.
Breastfeeding will not be permitted 45 minutes prior to vaccine administration and 45 minutes after each vaccine administration.
|
Experimental: 14 weeks RV & Normal breastfeeding
Administration of Rotarix at 14 and 18 weeks co-administered with oral polio virus, with no intervention in normal breastfeeding practices before and after receiving vaccine.
|
Administration of Rotarix at 6 and 10 weeks co-administered with oral polio virus vaccine with no intervention in normal breastfeeding practices before and after receiving vaccine.
Administration of Rotarix at 6 and 10 weeks co-administered with oral polio virus.
Breastfeeding will not be permitted 45 minutes prior to vaccine administration and 45 minutes after each vaccine administration.
Administration of Rotarix at 14 and 18 weeks co-administered with oral polio virus, with no intervention in normal breastfeeding practices before and after receiving vaccine.
Administration of Rotarix at 14 and 18 weeks co-administered with oral polio virus.
Breastfeeding will not be permitted 45 minutes prior to vaccine administration and 45 minutes after each vaccine administration.
|
Experimental: 14 weeks RV & delayed breastfeedin
Administration of Rotarix at 14 and 18 weeks co-administered with oral polio virus.
Breastfeeding will not be permitted 45 minutes prior to vaccine administration and 45 minutes after each vaccine administration.
|
Administration of Rotarix at 6 and 10 weeks co-administered with oral polio virus vaccine with no intervention in normal breastfeeding practices before and after receiving vaccine.
Administration of Rotarix at 6 and 10 weeks co-administered with oral polio virus.
Breastfeeding will not be permitted 45 minutes prior to vaccine administration and 45 minutes after each vaccine administration.
Administration of Rotarix at 14 and 18 weeks co-administered with oral polio virus, with no intervention in normal breastfeeding practices before and after receiving vaccine.
Administration of Rotarix at 14 and 18 weeks co-administered with oral polio virus.
Breastfeeding will not be permitted 45 minutes prior to vaccine administration and 45 minutes after each vaccine administration.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Immunogenicity of Rotavirus Vaccine
Periodo de tiempo: 24 months
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Sero-conversion rate of anti-rotavirus IgA
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24 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
anti-rotavirus IgA
Periodo de tiempo: 24 months
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Geometric mean concentration of anti-rotavirus IgA Enterovirus excretion in children at the time of vaccination
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24 months
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Colaboradores e Investigadores
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
- PR-09070
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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