Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00329745
Status:
COMPLETED
Last Update Posted:
2016-12-09
First Post:
2006-05-24
Brief Title:
Year 3 Extension for Efficacy Follow-up in Subjects Vaccinated in Studies Rota-028 029 or 030 NCT00197210
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:
2016-10
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:
This Year 3 extension of the main study rota-028 029 or 030 is conducted to evaluate vaccine efficacy against severe rotavirus RV gastroenteritis GE during third year of life in infants previously vaccinated with human rotavirus HRV vaccine or placebo in the following schedules
at 3 and 4 months of age in study rota-028 at 2 and 4 months of age in study rota-029 or rota-030
The Protocol Posting has been updated in order to comply with the FDA Amendment Act Sep 2007
at 3 and 4 months of age in study rota-028 at 2 and 4 months of age in study rota-029 or rota-030
The Protocol Posting has been updated in order to comply with the FDA Amendment Act Sep 2007
Detailed Description:
Note that no new subjects will be recruited in this extension phase studies
The expected total enrolment for the primary studies was as follows
rota-028 5700 rota-029 3018 rota-030 1102
The expected total enrolment for the primary studies was as follows
rota-028 5700 rota-029 3018 rota-030 1102
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 |
|---|---|---|---|
| 107076 | OTHER | GSK | None |
| 107072 | OTHER | None | None |