This study was conducted to evaluate the lot-to-lot consistency of three lots of HBV-MPL vaccine and to compare their safety and immunogenicity with that of Engerix™-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
SINGLE
Enrollment
1,303
2-dose intramuscular injection 3 different vaccine lots
3-dose intramuscular injection
GSK Clinical Trials Call Center
Parkville, Victoria, Australia
GSK Clinical Trials Call Center
Hradec Kralové, Czechia
GSK Clinical Trials Call Center
München, Germany
GSK Clinical Trials Call Center
Bari, Italy
Occurrence, intensity and causal relationship of any (solicited/unsolicited adverse event) general symptoms
Time frame: Full course of vaccination
Incidence of serious adverse events
Time frame: Study period
Anti-HBs antibody concentrations
Time frame: At Month 7
Occurrence and intensity of solicited local signs and symptoms
Time frame: 4-day after vaccination
Occurrence, intensity and relationship to vaccination of solicited general signs and symptoms
Time frame: 4-day after vaccination
Occurrence, intensity and relationship to vaccination of unsolicited signs and symptoms
Time frame: 30 days after vaccination
Occurrence and relationship to vaccination of SAEs
Time frame: During the study period
Anti-HBs antibody concentrations
Time frame: At Months 1, 2, 6 and 7
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
GSK Clinical Trials Call Center
Utrecht, Netherlands
GSK Clinical Trials Call Center
Lausanne, Switzerland
GSK Clinical Trials Call Center
London, United Kingdom