Primary Outcome Measures:
- To compare between herpes simplex vaccine (gD2t with adjuvant) and placebo the general safety of the vaccine by recording all the unsolicited adverse experiences [ Time Frame: During the 7 month vaccination period ]
- To evaluate the protective efficacy of gD2t with adjuvant to prevent acquisition of genital herpes disease in healthy female adults who are HSV seronegative or HSV seropositive at baseline [ Time Frame: Survival analysis beginning at Month 0 ]
Secondary Outcome Measures:
- To evaluate the protective efficacy of gD2t with adjuvant vaccine to prevent acquisition of genital herpes disease in healthy female adults who are HSV seronegative at baseline [ Time Frame: Survival analysis beginning at Month 0 ]
- To evaluate the protective efficacy of the gD2t with adjuvant vaccine to prevent acquisition of genital herpes disease in healthy male and female adults who are HSV seronegative or HSV-1 seropositive at baseline [ Time Frame: Survival analysis beginning at Month 0 ]
- To evaluate the protective efficacy of the gD2t with adjuvant vaccine to prevent acquisition of genital herpes disease in healthy female adults who are HSV seronegative or HSV-1 seropositive at baseline [ Time Frame: After 3 doses of vaccine (between months 7 and 19) ]
- To evaluate the protective efficacy of the gD2t with adjuvant vaccine to prevent symptoms of genital herpes disease in healthy female adults who are HSV seronegative at baseline [ Time Frame: Survival analysis beginning at Month 0 ]
- To evaluate the protective efficacy of gD2t with adjuvant vaccine to prevent HSV infection in healthy female adults who are HSV seronegative or HSV-1 seropositive at baseline
- To evaluate the protective efficacy of gD2t with adjuvant vaccine to prevent HSV infection in healthy female adults who are HSV seronegative at baseline.
This study was monitored by a Data Safety Monitoring Board At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham