drugset / Trial / NCT00346892

To Evaluate 2 Doses of GSK Biologicals' Oral Live Attenuated Human HRV Vaccine Co-administered With Either OPV or IPV

NCT00346892

Phase 2 Completed 450 enrolled GlaxoSmithKline
RandomizedParallel-groupDouble-blindPrevention

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 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."

Timeline

Start
2001-11
Primary completion
2003-03
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Rotarix Vaccine Oral

Indications