This study is undertaken to assess the immune response and safety profile of 4 lots of the novel adjuvanted hepatitis B vaccine that were formulated following different processes, with Engerix™-B as the control vaccine
This is an open, randomized study with five groups, but the four groups receiving HBV-MPL candidate vaccine are double-blinded. 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
200
3-dose intramuscular injection
2-dose intramuscular injection
GSK Clinical Trial Call Center
Brussels, Belgium
Anti-HBs antibody concentrations
Time frame: At month 7
Anti-HBs antibody concentrations
Time frame: At months 1, 2 and 6
Occurrence and intensity of solicited local and general symptoms
Time frame: 4-day follow-up period after each vaccination
Occurrence, intensity and relationship to vaccination of unsolicited symptoms
Time frame: 30-day follow-up period after each vaccination
Occurrence, intensity and relationship to vaccination of SAEs
Time frame: Throughout the entire study
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