Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00224484
Status:
COMPLETED
Last Update Posted:
2019-01-07
First Post:
2005-09-21
Brief Title:
Safety Study of Herpes Simplex Vaccine in HSV Seronegative and Seropositive Females Between 10 and 17 Years Old
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline Biologicals Herpes Simplex Candidate Vaccine gD2-AS04 in Healthy HSV Seronegative and Seropositive Female Subjects Aged 10-17 Years
Status:
COMPLETED
Status Verified Date:
2019-01
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:
Main goal of this study is to compare the occurrence of serious adverse events SAEs between the herpes simplex gD2-AS04 vaccine group and the Saline control group throughout the study period up to month 12
The Protocol Posting has been updated in order to comply with the FDA Amendment Act Sep 2007
The Protocol Posting has been updated in order to comply with the FDA Amendment Act Sep 2007
Detailed Description:
Three groups of females 3000 1500 and 1500 subjects respectively were injected 3 times at months 0 1 and 6 with the herpes simplex vaccine the HavrixTM vaccine control and a Saline solution placebo respectively Subjects were followed over 18 months
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