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Also known as GSK208141 vaccine, Herpes simplex vaccine, gD2-AS04 vaccine
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 developed by GSK plc for herpes simplex. It has been studied in Phase 3 clinical trials as a vaccine approach for herpes simplex in adolescent and adult females. Both of its completed trials enrolled healthy volunteers who were tested for herpes simplex virus antibodies.
GSK208141 was studied for the prevention of herpes simplex infection in females. Its clinical program focused on HSV seronegative and seropositive females aged 10 years and older. The trials evaluated safety and immune response rather than treatment of existing disease, and the studies are now completed.
GSK208141 is developed by GSK plc, which trades under the ticker GSK. GSK sponsored both Phase 3 trials of the candidate, including the large safety study in HSV seronegative and seropositive females and the lot consistency study comparing commercial scale manufacturing lots.
GSK208141 has completed Phase 3 clinical development. Both of its Phase 3 trials are listed as completed, with no active trials ongoing. It is an investigational product and is not described as approved for any indication.
GSK208141 was evaluated in two completed Phase 3 trials: NCT00224484, a safety study in HSV seronegative and seropositive females aged 10 to 17, which enrolled 5,960 participants, and NCT00224471, a study comparing commercial scale consistency lots, which enrolled 671 participants. Together the trials enrolled 6,631 people.
Yes, GSK208141 vaccine is another name for GSK208141. Both names refer to the same GSK plc monoclonal antibody candidate studied for herpes simplex. Searches using either name point to the same Phase 3 program, including trials NCT00224484 and NCT00224471.