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About
Main goal of this study is to compare the occurrence of serious adverse events (SAEs) between the herpes simplex (gD2-AS04) vaccine group and the Saline control group throughout the study period (up to month 12).
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Full description
Three groups of females (3000, 1500 and 1500 subjects, respectively) were injected 3 times (at months 0, 1 and 6) with the herpes simplex vaccine, the HavrixTM vaccine (control) and a Saline solution (placebo), respectively. Subjects were followed over 18 months.
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Interventional model
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5,960 participants in 3 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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