Evaluate, one month after the third dose, the lot-to-lot consistency of 3 different commercial scale production lots of the candidate vaccine in healthy HSV 1-/2- females aged 10-17 years, determined by ELISA. Absence in significant variation for both parameters among the tested lots was hypothesized.
At month 0, 1 and 6, 3 groups of 184 subjects received each 3 doses of herpes simplex vaccine lot A, B or C, respectively. The study took 14 months to complete, including screening, and 6 visits were required. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
671
3 IM doses
GSK Investigational Site
Mesa, Arizona, United States
GSK Investigational Site
Fountain Valley, California, United States
GSK Investigational Site
Golden, Colorado, United States
Anti-gD antibody titre in the entire cohort (10-17 yrs)
Time frame: At month 7
Anti-gD antibody titre
Time frame: At months 2 and 12
Anti-HSV neutralizing antibodies
Time frame: At months 2, 7 and 12
Occurrence and intensity of solicited local symptoms. Resulting school absenteeism will also be evaluated.
Time frame: Within 7 days after each vaccination
Occurrence, intensity, relationship to vaccination and resulting school absenteeism of solicited general symptoms
Time frame: Within 7 days after each vaccination
Occurrence, intensity, relationship to vaccination and resulting school absenteeism of unsolicited adverse events
Time frame: Within 30 days after any vaccination
Occurrence of new onset chronic diseases and other medically significant conditions, regardless of causal relationship to vaccination and intensity
Time frame: Throughout the study
Occurrence and relationship to vaccination of SAEs
Time frame: Throughout the study period
Anti-gD antibody titre in sera from HSV-042 subjects and in an equally sized subset of sera from adults from study 208141/039
Time frame: At month 7
Seroconversion rate by anti-gD ELISA. in HSV-042 subjects and in an equally sized subset of adults from study 208141/039
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
GSK Investigational Site
Cincinnati, Ohio, United States
GSK Investigational Site
Charleston, South Carolina, United States
GSK Investigational Site
Galveston, Texas, United States
GSK Investigational Site
Salt Lake City, Utah, United States
GSK Investigational Site
Salt Lake City, Utah, United States
GSK Investigational Site
Seattle, Washington, United States
GSK Investigational Site
Ghent, Belgium
...and 3 more locations
Time frame: At month 7
In the event that a cell-mediated immune correlate of protection is identified in study 208141/039: assessment of the immune correlate of protection in a random subset of HBV-042 subjects
Time frame: At months 0, 2, 7, and 12