Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00139334
Status:
COMPLETED
Last Update Posted:
2016-09-21
First Post:
2005-08-30
Brief Title:
A Study to Test 2 Doses of the HRV Vaccine Given With or Without OPV in Healthy Infants in Bangladesh
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Evaluate Immunogenicity Reactogenicity Safety of 2 Doses of GSK Biologicals Oral Live Attenuated HRV Vaccine RIX4414 at 1065 CCID50 When Given Concomitantly With OPV Versus Given Alone HRV Vaccine Dose Given 15 Days After the OPV Dose in Healthy Infants in Bangladesh
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 main objective of this study is to provide immunogenicity data for GSK Biologicals HRV vaccine when co-administered with OPV or when given alone HRV vaccine dose given 15 days after the OPV dose
Detailed Description:
The study will have four groups Group HRV OPV Group HRV alone Group Placebo OPV and Group Placebo alone Two-dose immunisation will be administered in healthy infants at approximately 12 and 16 weeks of age Immunogenicity reactogenicity and safety relative to the placebo will also be evaluated Treatment allocation randomized 2211 Routine EPI vaccines should be administered during the study following the EPI recommendation in Bangladesh
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