The purpose of this study is to compare the immunogenicity and reactogenicity of the adjuvanted recombinant hepatitis B vaccine with that of Engerix™-B when both are injected according to a three dose schedule (0, 1, 6 months) in an adult non-responder population
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
SINGLE
Enrollment
116
Intramuscular injection, 3 doses
Intramuscular injection, 3 doses
GSK Clinical Trials Call Center
Leuven, Belgium
Anti-HBs antibody concentrations
Time frame: At month 7
Anti-HBs antibody concentrations
Time frame: At months 2, 6, 7 and 12
Occurrence and intensity of solicited local symptoms
Time frame: 4-day follow-up after vaccination
Occurrence, intensity and relationship of solicited general symptoms
Time frame: 4-day follow-up after vaccination
Occurrence, intensity and relationship to vaccination of unsolicited symptoms
Time frame: Within 30 days after vaccination
Incidence of serious AEs
Time frame: Throughout the entire study up to and including 30 days after the last vaccination
Cell mediated immunity
Time frame: At months 0, 2, 6, 7, 12
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