Status:
COMPLETED
A Study to Test 2 Doses of the HRV Vaccine Given With or Without OPV in Healthy Infants in Bangladesh
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Rotavirus
Eligibility:
All Genders
5-7 years
Phase:
PHASE2
Brief Summary
The main objective of this study is to provide immunogenicity data for GSK Biologicals' HRV vaccine when co-administered with OPV or when given alone (HRV vaccine dose given 15 days after the OPV dose...
Detailed Description
"The study will have four groups: Group HRV + OPV, Group HRV alone, Group Placebo + OPV and Group Placebo alone. Two-dose immunisation will be administered in healthy infants at approximately 12 and 1...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Healthy infants aged 6 weeks±1 at first study vaccination.
- Exclusion criteria:
- Malnutrition, no history of rotavirus gastroenteritis, allergic disease or chronic gastrointestinal disease, not received protocol-prohibited treatment.
Exclusion
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
End Date :
January 1 2006
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00139334
Start Date
June 1 2005
End Date
January 1 2006
Last Update
September 21 2016
Active Locations (1)
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1
GSK Investigational Site
Dhaka, Bangladesh, 1000