Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00370682
Status:
COMPLETED
Last Update Posted:
2017-05-30
First Post:
2006-08-30
Brief Title:
A Phase II Trial of a Live Attenuated Virus Tetravalent Dengue Vaccine in Healthy Adults in Thailand
Sponsor:
US Army Medical Research and Development Command
Organization:
US Army Medical Research and Development Command
Study Overview
Official Title:
Phase II Randomized Double-blind Single Center Controlled Study of Two Doses of Different Formulations of the WRAIR Live Attenuated Tetravalent Dengue Vaccine Compared to a Placebo Control Administered on a 0-6 Month Schedule to Healthy Adults
Status:
COMPLETED
Status Verified Date:
2017-05
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 descriptive study will evaluate the safety and immunogenicity of different formulations of the WRAIR dengue vaccine compared to a placebo
Detailed Description:
Subjects will be randomized into one of three groups One group will receive a placebo vaccine and the other two will receive different dengue vaccine formations Each subject will receive two doses six months apart All subjects will have 11 venipunctures during 11 visits ie screening plus 10 study visits over a period of nine months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| Study no 103854 T-DEN-002 | OTHER | None | None |
| HSRRB A-13699 | OTHER | USAMRMC | None |