The purpose of the study is to compare the safety, reactogenicity and immunogenicity of different formulations of adjuvanted recombinant hepatitis B vaccine to that of Engerix™-B when administered at 0, 2 months with a booster at month 12 if necessary
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
TRIPLE
Enrollment
60
Intramuscular injection, 2 or 3 doses, 2 different formulations
Intramuscular injection, 2 or 3 doses
GSK Clinical Trials Call Center
Vienna, Austria
Anti-HBs antibody concentrations
Time frame: At M3 and M13
Occurrence of local and general solicited symptoms
Time frame: 4-day follow-up after vaccination
Occurrence of unsolicited symptoms
Time frame: 30-day follow-up after vaccination
SAEs
Time frame: Throughout the study up to 30 days after last vaccination
Anti-HBs antibody concentrations
Time frame: Months 2, 3, 6, 9, 12, 13
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