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.
- 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
|Study Start Date:||November 2001|
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 were to receive two doses of HRV or placebo at approximately 6 and 10 weeks of age (first cohort) and subjects enrolled after the 2002 RV season received vaccinations at approximately 10 and 14 weeks of age (second cohort). Routine EPI vaccinations were to be administered concomitantly with the study vaccines.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00346892
|Pretoria, South Africa|
|Study Director:||Clinical Trials||GlaxoSmithKline|