The purpose of this study is to enroll pre-liver transplant patients who will be vaccinated with either the novel adjuvanted HBV vaccine or double doses of Engerix™-B. The immunogenicity and safety of the novel adjuvanted vaccine will be compared to Engerix™-B as the control vaccine
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
93
2-dose primary vaccination followed by 1 booster vaccination by intramuscular injection
3-dose primary vaccination followed by 1 booster vaccination by intramuscular injection of double doses
Anti-HBs antibody concentrations
Time frame: At Day 28
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 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
Anti-HBs antibody concentrations
Time frame: At d21, d28, d56, M6-12, 1M after booster dose
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