To Evaluate 2 Doses of GSK Biologicals' Oral Live Attenuated Human HRV Vaccine Co-administered With Either OPV or IPV
"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 of combined vaccines.
The primary objective was reached if one month after the third dose of polio vaccine, upper limit of the 95% CI for the difference in Seroprotection rate between the group B and C pooled and (minus) the group A was below 10% for each polio serotype."
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Official Title:||Reactogenicity & Immunogenicity Study of Two Doses of GSK Biologicals' Oral Live Attenuated HRV Vaccine Co-administered With Either OPV or IPV in Healthy Infants (Approximately 5-10 Weeks Old) in South Africa|
- Seroprotection for each polio serotype 1 month after the 3rd dose. [ Designated as safety issue: No ]
- Proportion of subjects with vaccine take 1 month after each dose of study vaccine, viral shedding in a subset of subjects, presence of RV in diarrheal stools, anti-rota IgA antibody seroconversion rate and serum anti-rota IgA antibody concent [ Designated as safety issue: No ]
|Study Start Date:||November 2001|
|Primary Completion Date:||March 2003 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00346892
|Pretoria, South Africa|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|