Hepatitis B
Conditions
Brief summary
Comparison of adjuvanted hepatitis B vaccine to double dose of Engerix™-B in pre- /haemodialysis patients aged ≥15 years.
Interventions
BIOLOGICALHepatitis B adjuvanted vaccine
BIOLOGICALEngerix-B
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A male or female \> = 15 years of age at the time of the first vaccination. * Written informed consent obtained from the subject/ from the parents or guardians of the subject. * Seronegative for anti-HBs antibodies, anti-HBc antibodies & Hepatitis B Surface antigen (HBsAg). * If the subject was a female, she was of non-childbearing potential or, if of childbearing potential, she had to be abstinent or use adequate contraceptive precautions for one month prior to enrollment and up to two months after the last vaccination. * Pre-haemodialysis patient\* or a patient on haemodialysis.
Exclusion criteria
* Use of any investigational or non-registered drug or vaccine other than the study vaccine during the study period or within 30 days preceding the first dose of study vaccine. * Previous vaccination against hepatitis B. * History of hepatitis B infection. * Known exposure to hepatitis B virus within 6 weeks. Pregnant or lactating female * Clinically abnormal ALT/AST values (\> 3 times normal values)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anti-HBs seroprotection rates at Month 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Solicited symptoms, unsolicited symptoms and serious adverse events | — |
Countries
Czechia, Malaysia, Spain
Outcome results
None listed