Status:
COMPLETED
To Evaluate 2 Doses of GSK Biologicals' Oral Live Attenuated Human HRV Vaccine Co-administered With Either OPV or IPV
Lead Sponsor:
GlaxoSmithKline
Conditions:
Rotavirus Infections
Eligibility:
All Genders
5-10 years
Phase:
PHASE2
Brief Summary
"The primary objective of this study was to demonstrate that co-administering HRV vaccine with OPV does not induce a significant decrease in poliovirus immune response one month after the third dose o...
Detailed Description
The study had three groups: Group A: HRV + OPV + DTPa/Hib; Group B: HRV + placebo OPV + DTPa-IPV/Hib; Group C: HRV Placebo + OPV + DTPa/Hib. Two cohorts: Subjects enrolled before the 2002 RV season we...
Eligibility Criteria
Inclusion
- Inclusion criteria: Healthy infants between 5 and 10 weeks of age at first study vaccination with (after the 2002 RV season) confirmed negative HIV status of the subject's mother during pregnancy or thereafter. Exclusion criteria: History of allergic disease, any confirmed or suspected immunosuppressive or immunodeficient condition, clinically significant history of chronic gastrointestinal disease or other serious medical condition as determined by the investigator or had not received treatment prohibited by the protocol.
Exclusion
Key Trial Info
Start Date :
November 1 2001
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT00346892
Start Date
November 1 2001
Last Update
September 9 2016
Active Locations (1)
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1
Pretoria, South Africa