Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00346892
Status:
COMPLETED
Last Update Posted:
2016-09-09
First Post:
2006-02-03
Brief Title:
To Evaluate 2 Doses of GSK Biologicals Oral Live Attenuated Human HRV Vaccine Co-administered With Either OPV or IPV
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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 DTPaHib Group B HRV placebo OPV DTPa-IPVHib Group C HRV Placebo OPV DTPaHib 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None