The purpose of the present study is to evaluate the immunogenicity and safety of three consecutive production lots of the novel adjuvanted HBV vaccine. The safety of the candidate vaccine will be assessed using Engerix™-B as control.
Double-blind for the identity of the consistency lots, single-blind for the control group/study vaccine identity. 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
951
3 consecutive lots; 3-dose intramuscular injection
3-dose intramuscular injection
Anti-HBs antibody concentrations
Time frame: At month 3
Anti-HBs antibody concentrations
Time frame: At M1, M2, M3
Anti-RF1 antibody titres in a subset of 50 subjects per group
Time frame: At months 0 and 3
Occurrence, intensity and relationship to vaccination of solicited local and general signs and symptoms
Time frame: During a 4-day follow-up after vaccination
Occurrence, intensity and relationship to vaccination of unsolicited symptoms
Time frame: Within 30 days after each vaccination
Occurrence, intensity and relationship to vaccination of serious adverse events
Time frame: During the study period
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.