The study vaccine has been developed for use in pre-dialysis/ haemodialysis patients and immuno-compromised individuals who could have or had a sub-optimal response following vaccination for hepatitis B with currently available commercial vaccines (target population). This study will aim to confirm in a clinical setting the consistency of production of three lots of the vaccine.
Double-blind, randomised, single centre study with three groups receiving three different lots of Henogen's adjuvanted hepatitis B vaccine according to 0, 1 months schedule. Blood samples will be taken at Month 0, Months 1 and 2.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
450
20 µg, IM, month 0 and 1
20µg, IM, month 0 and 1
20µg, IM, month 0 and 1
Vaccination and Travel Medicine Centre Poliklinika II
Hradec Králové, Czechia
Anti-HBs seroprotection rates at Month 2.
Time frame: Month 2
Anti-HBs geometric mean concentration, seropositivity rates, seroprotection rates and the percentage of subjects with antibody concentrations superior or equal to 100 mIU/ml after HB-AS02V vaccination, at all time points.
Time frame: Month 0, 1 and 2
Occurrence and intensity of solicited local signs and symptoms, as well as occurrence, intensity and relationship to vaccination of solicited general signs and symptoms, within 4 days after administration of study vaccine (Day 0 to 3).
Time frame: Month 0 and 1
Occurrence, intensity and relationship to vaccination of unsolicited symptoms after administration of study vaccine (Day 0 to 30)
Time frame: Month 0 and 1
Occurrence, intensity and relationship to vaccination of all serious adverse events (SAEs) up to Month 2.
Time frame: Month 0 to 2
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