Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00197210
Status:
COMPLETED
Last Update Posted:
2016-11-04
First Post:
2005-09-15
Brief Title:
A Study to Test 2 Doses of GSK Biologicals Oral Live Attenuated Human Rotavirus HRV Vaccine in Healthy Infants
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Phase III Double-blind Randomized Placebo-controlled Multi-country and Multi-center Study to Assess the Efficacy and Safety of Two Doses of GSK Biologicals Oral Live Attenuated Human Rotavirus HRV Vaccine in Healthy Infants
Status:
COMPLETED
Status Verified Date:
2016-11
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 objectives of this study are to determine vaccine efficacy against severe rotavirus RV gastroenteritis GE during the period starting from 2 weeks after Dose 2 until two years of age and to determine the safety of GSK Biologicals HRV vaccine with respect to definite intussusception IS within 31 days Day 0-Day 30 after each HRV vaccine dose
Detailed Description:
The study has two groups Group HRV and Group Placebo Two oral doses administered to healthy infants who are 6-12 weeks of age in Hongkong and Taiwan or 11-17 weeks of age in Singapore according to a 0 1 to 2-month schedule Routine vaccinations are given concomitantly with the study vaccines at 2 or 3 and 4 months of age according to each local country regulation Whenever OPV is used a minimum 2-week interval should be observed between HRV vaccine and OPV doses
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 444563030 | OTHER | GSK | None |
| 444563029 | OTHER | None | None |