Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00224484 | Safety Study of Herpes Simplex Vaccine in HSV Seronegative and Seropositive Females Between 10 and 17 Years Old | PHASE3 | COMPLETED | 5,960 | — | — | Apr 7, 2004 | Jul 24, 2007 | Jan 7, 2019 | 151 | United States, Australia +16 |
| NCT00224471 | Study to Compare Safety and Immunogenicity of Commercial Scale Consistency Lots of Herpes Simplex Vaccine | PHASE3 | COMPLETED | 671 | — | — | Dec 1, 2003 | Jan 1, 2006 | Sep 21, 2016 | 13 | United States, Belgium +1 |
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
| Arm | Type | Description |
|---|---|---|
| GD2-AS04 GROUP | EXPERIMENTAL | Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule. |
| HAVRIX GROUP | ACTIVE_COMPARATOR | Female subjects aged 10-17 years, who received 3 doses of Havrix, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule. |
| SALINE GROUP | PLACEBO_COMPARATOR | Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule. |
| Group A | EXPERIMENTAL | - |
| Group B | EXPERIMENTAL | - |
| Group C | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| GSK208141 | BIOLOGICAL | 3 intramuscular doses |
| Havrix (investigational formulation) | BIOLOGICAL | 3 intramuscular doses |
| Placebo | BIOLOGICAL | 3 intramuscular doses |
| GSK208141 vaccine | BIOLOGICAL | 3 IM doses |
Inclusion Criteria: * Subjects who the investigator believes that can and will comply with the requirements of the protocol should be enrolled in the study. * Healthy female between, and including, 10 and 17 years of age at the time of the first vaccination. * Written informed assent obtained from ...