This study compares the immunogenicity and safety of the novel adjuvanted HBV vaccine and Engerix™-B administered to subjects who were positively identified as having the HLA-DQ2 genotype
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
230
2-dose intramuscular injection
3-dose intramuscular injection
Anti-HBs antibody concentrations
Time frame: At month 7
Occurrence, intensity and relationship to vaccination of solicited local and general signs and symptoms
Time frame: During a 4 day follow-up period after each vaccination
Occurrence, intensity and relationship to vaccination of unsolicited symptoms
Time frame: During a 30 day follow-up period after each vaccination
Occurrence, intensity and relationship to vaccination of serious adverse events (SAEs)
Time frame: During the study period
Anti-HBs antibody concentrations
Time frame: Day 0, Month 1, Month 6 and Month 7
Cell mediated immunity
Time frame: At Months 0 and 7
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.