Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK208141 · 2 trials · 1 indication
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 ...
GSK208141 is an investigational monoclonal antibody being developed by GSK plc for Herpes Simplex. It is currently in Phase 3 clinical development, though the two Phase 3 trials listed have been completed. The drug is being studied in healthy female volunteers aged 10 years and older.
GSK208141 is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug's safety and immunogenicity in the context of Herpes Simplex.
GSK208141 is in Phase 3 clinical development. Two Phase 3 trials have been completed, with a total enrollment of 6,631 participants. The drug is investigational and not yet approved, as it remains in clinical development.
GSK208141 has been studied in two completed Phase 3 trials: NCT00224471, which compared safety and immunogenicity of commercial scale consistency lots of a Herpes Simplex vaccine, and NCT00224484, a safety study in HSV seronegative and seropositive females aged 10 to 17 years.
GSK208141 is described as a monoclonal antibody, but the clinical trials listed evaluate a Herpes Simplex vaccine. The trials are Phase 3, completed, and enrolled healthy female volunteers. The drug is being developed for Herpes Simplex, and the trials assess safety and immunogenicity.