10.25934/00002923
GlaxoSmithKline
A Double-Blind, Randomized, Controlled Phase III Study to Assess the Prophylactic Efficacy and Safety of gD-Alum/MPL Vaccine in the Prevention of Genital Herpes Disease in Young Women Who Are HSV-1 and -2 Seronegative
Vivli
2018
Conditions: Herpes Simplex Infection
Interventions: HSV vaccine or SB208141, GSK Biologicals' glycoprotein D (gD)-Alum/3-deacylated form of Monophosphoryl Lipid A (MPL) candidate genital herpes vaccine
Interventions: Havrix™, GlaxoSmithKline (GSK) Biologicals' licensed Hepatitis A vaccine
2003-01/2009-08
Study data may be accessed by completing a request form at https://vivli.org. It will then be reviewed according to the data contributor’s governance policy, see https://vivli.org/members/ourmembers/ for Vivli member’s review process. If approved, use of the data is governed by the data use agreement at https://vivli.org/resources/vivli-data-use-agreement/
The primary purpose of this study is to see if a herpes vaccine may prevent genital herpes disease in women who are not infected. The study will enroll approximately 7550 healthy women. These women will be randomly assigned to 1 of 2 possible study groups: herpes vaccine (experimental group) or hepatitis A vaccine (control group). Participants will receive their assigned vaccine at 0, 1, and 6 months. Participants will have 9 scheduled study visits and additional unscheduled visits for an evaluation of herpes if it is suspected. Participants will be involved in study related procedures for up to 20 months.