NCT00346892

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 450 (planned)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 5 Weeks – 10 Weeks
• Healthy volunteers: Accepted

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."

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 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.

Conditions

• Rotavirus Infections

Interventions

Type	Name	Description
BIOLOGICAL	Rotavirus (vaccine)

Timeline

• Start date: 2001-11-01
• Primary completion: 2003-03-01
• First posted: 2006-06-30
• Last updated: 2016-09-09

Locations

1 site across 1 country: South Africa