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

Grants and Contracts Details


I. GENERAL DESCRIPTION OF WORK ~ A. Obtain IRB approval for the study protocol, data collection forms and participant informed " consent forms at all institutions where the investigator intends to enroll participants for this study. B. Enroll participants during the performance period of this Agreement according to the study protocol. C. Follow, according to the study protocol, all enrolled participants through the end of the performance period of this Agreement. D. Complete and submit to PRIMARY AGENCY, in a timely fashion, all data forms required by the study protocol. E. Respond, in a timely fashion, to all inquiries from the EMMES Corporation including but not limited to data collection, human subjects issues, study travel and site visits. F. Attend the following meetings: Investigator meetings, approximately 2 per year (Clinical Center Director and Research Coordinator) Training meeting, (Research Coordinator) G. Participate in subcommittee work as assigned. H. Visits to SUBCONTRACTOR's site(s) may be made by PRIMARY AGENCY personnel and/or GSK, PPD, or EMMES personnel at any time during the performance period of this Agreement. When appropriate, GSK will be notified in writing at least one (1) week prior to any site visit. I. Provide a method of contact to study volunteers during evenings and weekends for any possible study related emergencies.
Effective start/end date1/14/052/28/07


  • St Louis University: $42,512.00


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