Trials / Completed
CompletedNCT00224484
Safety Study of Herpes Simplex Vaccine in HSV Seronegative and Seropositive Females Between 10 and 17 Years Old
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
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 5,960 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- Female
- Age
- 10 Years – 17 Years
- Healthy volunteers
- Accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | GSK208141 | 3 intramuscular doses |
| BIOLOGICAL | Havrix (investigational formulation) | 3 intramuscular doses |
| BIOLOGICAL | Placebo | 3 intramuscular doses |
Timeline
- Start date
- 2004-04-07
- Primary completion
- 2007-07-24
- Completion
- 2007-07-24
- First posted
- 2005-09-23
- Last updated
- 2019-01-07
- Results posted
- 2017-04-10
Locations
151 sites across 18 countries: United States, Australia, Belgium, Canada, Denmark, Estonia, France, Greece, Hungary, Iceland, Lithuania, Netherlands, New Zealand, Norway, Romania, Spain, Sweden, United Kingdom
Source: ClinicalTrials.gov record NCT00224484. Inclusion in this directory is not an endorsement.