Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HSV vaccine or SB208141, GSK Biologicals' glycoprotein D-Alum/3-deacylated form of Monophosphoryl Lipid A candidate genital herpes vaccine · 1 trial · 1 indication
Genital herpes disease was defined as signs (swelling, papules, vesicles, ulcers, crusts, fissures, erythema, or vaginal discharge) and/or symptoms (pain, burning, itching, tingling, dysuria) which developed on the skin or mucosa of the anogenital region and/or buttocks and laboratory confirmation of Herpes Simplex Virus (HSV)-1 or 2 infection (either concomitant positive HSV culture or HSV seroconversion within 6 months after onset of signs and/or symptoms). Seroconversion to HSV-1 and/or HSV-2 was defined as a positive HSV-1 and/or HSV-2 Western blot in a subject with a previously negative Western blot result for the corresponding HSV type.
| Arm | Type | Description |
|---|---|---|
| Herpes Simplex Virus Group | EXPERIMENTAL | Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus (HSV) vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule. |
| Havrix Group | EXPERIMENTAL | Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule. |
| Name | Type | Description |
|---|---|---|
| HSV vaccine or SB208141, GSK Biologicals' glycoprotein D (gD)-Alum/3-deacylated form of Monophosphoryl Lipid A (MPL) candidate genital herpes vaccine | BIOLOGICAL | the vaccine was administered intramuscularly in the non-dominant deltoid |
| Havrix™, GlaxoSmithKline (GSK) Biologicals' licensed Hepatitis A vaccine | BIOLOGICAL | the vaccine was administered intramuscularly in the non-dominant deltoid |
Inclusion Criteria: * A female between, and including, 18 and 30 years of age at the time of the first vaccination. * Written informed consent obtained from the subject. * Free of obvious health problems as established by medical history and clinical examination before entering into the study. * Se...