Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00397943
Status:
COMPLETED
Last Update Posted:
2019-06-19
First Post:
2006-11-09
Brief Title:
Safety and Immunogenicity of 2 Formulations of Tuberculosis Vaccine GSK692342 Given at 01 Months to Healthy Adults
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Safety Reactogenicity Immunogenicity of 2 Formulations of Tuberculosis Vaccine GSK692342 Administered Intramuscularly According to a Schedule of 0 1 Month to Healthy Adults Aged 18 to 50 Years
Status:
COMPLETED
Status Verified Date:
2019-06
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 study will assess the safety and immunogenicity of 2 different formulations of tuberculosis vaccine GSK692342 in healthy adults
Detailed Description:
The study is designed to have a vaccination phase includes screening 2 doses of vaccine 1 month apart and follow-up until 1 month post dose 2 which will be performed in an observer blinded manner This will be followed by 3 years of follow-up which will continue in an open manner
No new subjects will be recruited at the follow-up phase The Protocol Posting has been updated in order to comply with the FDA Amendment Act Sep 2007
No new subjects will be recruited at the follow-up phase The Protocol Posting has been updated in order to comply with the FDA Amendment Act Sep 2007
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 |
|---|---|---|---|
| 106228 | OTHER | None | None |
| 108736 | OTHER | None | None |
| 108738 | OTHER | None | None |
| 2005-004497-24 | EUDRACT_NUMBER | GSK | None |