The purpose of the present trial is to assess the safety, reactogenicity and immunogenicity of adjuvanted hepatitis B vaccine, Engerix™-B and hepatitis B vaccine new formulation when administered at 0, 6 months
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
150
Intramuscular injection, 2 doses
Intramuscular injection, 2 doses
Intramuscular injection, 2 doses; experimental formulation
GSK Clinical Trials Call Center
Vienna, Austria
Anti-HBs antibody concentrations
Time frame: At month 7
Occurrence and intensity of solicited local and general symptoms
Time frame: 4-day follow-up after vaccination
Occurrence of unsolicited adverse events
Time frame: 30-days after vaccination
Incidence of serious adverse events
Time frame: Throughout the study period
Anti-Hbs antibody concentrations
Time frame: Months 1, 6 and 24
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