Status:
COMPLETED
Introduction of an Oral Live Human Rotavirus (Rotarix) Vaccine in Matlab
Lead Sponsor:
International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborating Sponsors:
PATH
Conditions:
Rotavirus Gastroenteritis
Eligibility:
All Genders
6-20 years
Phase:
PHASE4
Brief Summary
The study will be conducted in the Matlab Health and Demographic Surveillance System (HDSS) field area of the International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B) to determine th...
Detailed Description
This trial will determine the population effectiveness of Rotarix in Bangladeshi infants. The study will be conducted in both the government comparison area and the intervention area of the Matlab HDS...
Eligibility Criteria
Inclusion
- A male or female infant at least 6 weeks of age and not older than 20 weeks of age at the time of first dose of Rotarix.
- An infant whose parent or guardian's primary residence, at the time of first EPI vaccinations, is a village selected to receive Rotarix.
- Written informed consent obtained from the parent or guardian of the subject, prior to the subject's first study vaccination
Exclusion
- Hypersensitivity to the active substance or any component in the vaccine
- Hypersensitivity after previous administration of rotavirus vaccines.
- Previous history of intussusception.
- Subjects with uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusception.
- Infants with known or suspected immunodeficiency.
- Administration of Rotarix should be postponed in subjects suffering from an acute severe febrile illness only if that illness also results in postponement of other EPI vaccinations.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2011
Estimated Enrollment :
4550 Patients enrolled
Trial Details
Trial ID
NCT00737503
Start Date
September 1 2008
End Date
March 1 2011
Last Update
June 28 2011
Active Locations (1)
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1
ICDDR,B
Dhaka, Bangladesh, 1212