This study evaluates the safety and immunogenicity of the candidate HBV-MPL vaccine administered to healthy adults aged from 15 to 40 years, according to a 0, 6- month vaccination schedule, with Engerix™-B as control administered at 0, 1, 6 months.
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
NONE
Enrollment
340
2-dose intramuscular injection
3-dose intramuscular injection
GSK Clinical Trials Call Center
Brussels, Belgium
GSK Clinical Trials Call Center
Copenhagen, Denmark
Anti-HBs antibody concentrations
Time frame: Month 7
Anti-HBs antibody concentrations
Time frame: At months 1, 2, 6, 7 and 12
Occurrence, intensity and relationship to vaccination of solicited local and general symptoms
Time frame: 4-day follow-up period after vaccination
Occurrence, intensity and relationship to vaccination of unsolicited symptoms
Time frame: 31-day follow-up after vaccination
Occurrence and relationship to vaccination of Serious Adverse Events (SAEs)
Time frame: During the study period
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