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Clinical Trial Summary

The primary objectives of the study are: - To describe the safety profile of different investigational vaccine regimens against herpes simplex virus type 2 (HSV-2). - To evaluate the efficacy of the investigational vaccine regimens with respect to: - the frequency of herpes simplex virus (HSV) deoxyribonucleic acid (DNA) detection in the genital area (shedding rate) following a 2 dose vaccine schedule - the proportion of participants free of HSV genital recurrence at 6 months after the 2-dose vaccine schedule The secondary objectives of the study are: - To describe the impact of each of the investigational vaccine regimens in terms of total number of days with genital lesion up to 6 months after vaccination 2 and number of recurrences 60 days after the second vaccination compared with the placebo group - To describe the efficacy of each of the investigational vaccine regimens with respect to the frequency of HSV DNA detection in the genital area (shedding rate) 60 days following the first vaccination visit plus 60 days following the second vaccination visit compared with the placebo group - To describe the efficacy of each of the investigational vaccine regimens with respect to the frequency of HSV DNA detection in the genital area (shedding rate) 60 days following the first vaccination visit compared with the placebo group


Clinical Trial Description

Study duration per participant is approximately 16 months ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04222985
Study type Interventional
Source Sanofi
Contact
Status Terminated
Phase Phase 1
Start date February 18, 2020
Completion date May 19, 2021

See also
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