The purpose of this study is to evaluate the safety, immunogenicity and reactogenicity of MPL-adjuvanted recombinant hepatitis B vaccine in comparison with those of Engerix™-B in healthy adult volunteers following two different schedules: 0, 2 months and 0, 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
DOUBLE
Enrollment
99
Intramuscular injection, 1 or 3 doses
Intramuscular injection, 1 or 3 doses
GSK Clinical Trials Call Center
Wilrijk, Belgium
Anti-hepatitis B surface antigen (HBs) antibody concentrations
Time frame: One month after the full primary vaccination course and one month after the booster vaccination at 70 months
Anti-HBs antibody concentrations
Time frame: Months 1, 2, 3, 6, 12, 13, 42
Serious adverse experiences (SAE).
Time frame: Throughout the study period
Occurrence and intensity of solicited local symptoms
Time frame: 8-day follow-up after vaccination
Occurrence, intensity and relationship of solicited general symptoms
Time frame: 8-day follow-up after vaccination
Incidence of unsolicited symptoms
Time frame: During the 30-day follow-up after vaccination
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