This study will evaluate, versus a placebo, the safety of Herpes simplex candidate vaccine with adjuvant in initially HSV seropositive or seronegative subjects who have no genital herpes disease.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
7,460
Intramuscular injection, 3 doses
Intramuscular injection, 3 doses
To compare between herpes simplex vaccine and placebo recipients the general safety of the vaccine by recording all the unsolicited adverse experiences and all serious adverse experiences
Time frame: During a 30-day period after each vaccination (AEs), during 7 months after study start (SAEs)
To compare between vaccine and placebo recipients the incidence and severity of the reactogenicity as measured by recording the local reactions and the general symptoms
Time frame: On the day of each vaccination and on the following 3 days
To compare between vaccine and placebo recipients the effect on the haematological and biochemical parameters in subjects from 20% of the centers in each country
Time frame: At day -90 to day -7, and at month 7 and month 13
To compare between vaccine and placebo recipients the effect on pre-existing herpes simplex virus infection by recording the frequency and severity of all herpes simplex clinical episodes
Time frame: Day 0 through month 19
To evaluate the incidence and the types of the serious adverse experiences in both groups
Time frame: Month 7 to month 19
To evaluate the humoral immune response to the vaccine by measuring the anti-gD2 antibodies in a subset of vaccine and placebo recipients from each of the serostatus groups
Time frame: Before vaccination, and one month and 7 months after vaccination
To compare the anti-gD2 antibody responses between the subsets of HSV double seronegative and HSV-1 seropositive only vaccine recipients
Time frame: At months 7 and 13
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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