This trial is designed to evaluate the immunogenicity, reactogenicity and safety of an MPL-adjuvanted recombinant hepatitis B vaccine in comparison with those of Engerix™-B in haemodialysis patients with or without previous vaccination against hepatitis 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
DOUBLE
Enrollment
30
IM injection
IM injection
GSK Clinical Trials Call Center
Brussels, Belgium
Occurrence and intensity of solicited local and general symptoms
Time frame: 4-day follow-up period after each vaccination
Occurrence of unsolicited adverse events
Time frame: During the course of the study
Occurrence of serious adverse events
Time frame: During the course of the study
Anti-HBs antibody concentrations
Time frame: Pre, Day 0, Day 30, Day 60, Day 90, Day 120, D180, D210 depending on group allocation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.