This study is conducted to compare the immunogenicity, reactogenicity and safety of Engerix™-B and HBV-MPL vaccine against hepatitis B infection in an elderly population
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
380
3-dose intramuscular injection
3-dose intramuscular injection
GSK Clinical Trials Call Center
Wilrijk, Belgium
GSK Clinical Trials Call Center
Toronto, Canada
GSK Clinical Trials Call Center
Gothenburg, Sweden
Anti-HBs antibody concentrations
Time frame: At Month 7
Anti-HBs antibody concentrations
Time frame: At Months 1, 2, 6, 7 and 12
Occurrence and intensity of solicited local symptoms
Time frame: 4-day follow-up after vaccination
Occurrence and intensity and relationship to vaccination of solicited general symptoms
Time frame: 4-day follow-up after vaccination
Occurrence and intensity of any symptoms (solicited/ unsolicited).
Time frame: 4-day follow-up after vaccination
Occurrence, intensity and causal relationship of unsolicited symptoms
Time frame: Within 30 days after vaccination
Serious adverse events
Time frame: Throughout study period
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