The purpose of this study is to evaluate the immunogenicity and reactogenicity of various formulations of recombinant hepatitis B vaccine with different adjuvants in healthy adult volunteers following the 0, 1, 6 months schedule
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
60
Intramuscular injection, 3 doses
Intramuscular injection, 3 doses
GSK Clinical Trials Call Center
Ghent, Belgium
Occurrence and intensity of solicited local and general symptoms
Time frame: 8 days follow-up after vaccination
Anti-HBs antibody concentrations
Time frame: Months 0, 1, 3, 6, 7, 8 and 12
Occurrence, intensity of unsolicited adverse events
Time frame: 30-day follow-up after vaccination
Occurrence of serious adverse events
Time frame: During the study period up to 30 days after last vaccination
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