In the present study the immunogenicity, reactogenicity and safety of recombinant hepatitis B vaccines with and without MPL will be evaluated in older healthy subjects
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
TRIPLE
Enrollment
362
Intramuscular injection, 3 doses
Intramuscular injection, 3 doses
GSK Clinical Trials Call Center
Vienna, Austria
GSK Clinical Trials Call Center
Ghent, Belgium
GSK Clinical Trials Call Center
Hvidovre, Denmark
GSK Clinical Trials Call Center
Reykjavik, Iceland
Anti-hepatitis B surface antigen (HBs) antibody concentrations
Time frame: At M2 and M7
Anti-pre-S1 antibody concentrations
Time frame: Screening, Months 1, 2, 3, 6, 7, 8 and 12, depending on group allocation
Anti-HBs antibody concentrations
Time frame: Screening, Months 1, 2, 3, 6, 7, 8 and 12
Occurrence and intensity of local and general solicited symptoms
Time frame: 4-day after vaccination
Cell mediated immunity
Time frame: Month 0, Month 2 and month 7
Occurrence of unsolicited adverse events
Time frame: 30 days after vaccination
Occurrence of serious adverse events
Time frame: During the study period and 30 days after last vaccine dose
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