Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00057330
Status:
COMPLETED
Last Update Posted:
2018-08-27
First Post:
2003-03-31
Brief Title:
HerpeVac Trial for Young Women
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Double-Blind Randomized Controlled Phase III Study to Assess the Prophylactic Efficacy and Safety of gD-AlumMPL Vaccine in the Prevention of Genital Herpes Disease in Young Women Who Are HSV-1 and -2 Seronegative
Status:
COMPLETED
Status Verified Date:
2013-05
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:
The primary purpose of this study is to see if a herpes vaccine may prevent genital herpes disease in women who are not infected The study will enroll approximately 7550 healthy women These women will be randomly assigned to 1 of 2 possible study groups herpes vaccine experimental group or hepatitis A vaccine control group Participants will receive their assigned vaccine at 0 1 and 6 months Participants will have 9 scheduled study visits and additional unscheduled visits for an evaluation of herpes if it is suspected Participants will be involved in study related procedures for up to 20 months
Detailed Description:
This study is a double-blind randomized controlled Phase III trial to assess the prophylactic efficacy and safety of gD-AlumMPL vaccine in the prevention of genital herpes disease in young women who are herpes simplex virus HSV-1 and -2 seronegative The primary efficacy objective is to evaluate vaccine efficacy in the prevention of genital herpes disease caused by HSV-1 andor HSV-2 between months 2 and 20 in healthy adult women who were initially HSV-1 and HSV-2 seronegative The secondary efficacy objectives are to evaluate vaccine efficacy in the prevention of genital herpes disease caused by HSV-1 andor HSV-2 occurring between the months 7 and 20 evaluate vaccine efficacy in the prevention of HSV-2 infection between months 2 and 20 and to evaluate vaccine efficacy in the prevention of HSV-2 infection occurring between months 7 and 20 The study will enroll approximately 7550 women ages 18-30 years Participants will be randomized to 1 of 2 possible study groups candidate vaccine or control vaccine hepatitis A vaccine The study duration for each subject will be approximately 20 months Study procedures will include 9 scheduled study visits including the screening visit and additional unscheduled visits for evaluation of suspected herpes disease episodes Three doses of vaccine or control will be administered intramuscularly in the non-dominant deltoid on a 0 1 and 6 month schedule Subjects will attend clinic visits at screening months 2 7 12 16 and 20 In subjects who present with suspected herpes disease between months 17 and 20 an additional visit to collect a serum sample will be scheduled 3 months after the evaluation for suspected genital herpes
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 |
|---|---|---|---|
| 208141039 | OTHER | GSK | None |