This study will evaluate the immunogenicity and safety of different formulations of the HBV-MPL vaccine administered according to a 2-dose schedule and compare it to that of Engerix™-B administered according to a 3-dose schedule in order to determine the optimal dose of each component of the candidate HBV-MPL vaccine when administered at 0 and 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
160
5 different formulations, 2-dose intramuscular injection
3-dose intramuscular injection
GSK Clinical Trials Call Center
Vienna, Austria
Anti-HBs antibody concentrations
Time frame: Month 7
Anti-HBs antibody concentrations
Time frame: Month 1, 2 and 6
Occurrence, intensity and relationship to vaccination of solicited local and general symptoms
Time frame: 4-day follow-up after vaccination
Occurrence, intensity and relationship to vaccination of unsolicited symptoms
Time frame: 31-day follow-up after vaccination
Incidence of serious adverse events
Time frame: During the study period
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