Subjects who had not responded to previous hepatitis B vaccination were vaccinated with either the adjuvanted HBV-MPL vaccine or Engerix™-B vaccine according to a three-dose vaccination schedule (0, 1, 2 months) and boosted at Month 12 as per their group allocation. The immunogenicity and safety of the HBV-MPL vaccine were compared with the control vaccine, Engerix™-B.
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
145
3-dose primary vaccination and booster vaccination by intramuscular injection
3-dose primary vaccination and booster vaccination by intramuscular injection
Anti-HBs antibody concentrations
Time frame: Months 1, 2 and 3
Occurrence, intensity and relationship to vaccination of solicited local and general signs and symptoms
Time frame: During a 4 day follow-up period after vaccination
Occurrence, intensity and relationship to vaccination of unsolicited signs and symptoms
Time frame: During a 30 day follow-up period after vaccination
Occurrence, intensity and relationship to vaccination of serious adverse events (SAEs)
Time frame: During the study period, up to and including 6 months post-vaccination
Anti-HBs antibody concentrations in all subjects
Time frame: Months 1, 2, 3, 12 and 13
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