A Study to Compare the Immune Response and Safety Elicited by Henogen's Adjuvanted Hepatitis B Vaccine Compared to GSK Biologicals Adjuvanted Hepatitis B Vaccine in Pre-Dialysis and Dialysis Patients Who Have Not Been Exposed to Hepatitis B.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Henogen
With
GlaxoSmithKline
Study participants will receive either Henogen's adjuvanted hepatitis B vaccine or GSK Biologicals' adjuvanted hepatitis B vaccine. The study involves a total of 7 visits and blood samples will taken at each of these visits.
Age
15–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
A male or female subject 15 years of age or older at the time of the study entry.
Written informed consent obtained from the subject/ from the parent or guardian of the subject.
Seronegative for anti-HBs antibodies, anti-HBc antibodies and for HBsAg at screening.
Pre-dialysis patients, peritoneal dialysis patients or haemodialysis patients.
Non-childbearing potential female
You may not be if
Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Use of any registered vaccine within 7 days before the first dose of study vaccine.
Previous vaccination against hepatitis B (whether or not the subject responded to the vaccine).
History of hepatitis B infection.
Known exposure to hepatitis B virus within 6 months.
Use of immunoglobulins within six months preceding the first study vaccination.
Immunosuppression caused by the administration of parenteral steroids or chemotherapy (oral steroids are allowed).
Any confirmed or suspected human immunodeficiency virus (HIV) infection.
A family history of congenital or hereditary immunodeficiency.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
Acute disease at the time of enrolment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. oral/ axillary temperature \< 37.5°C (or 37 °C in Czech Republic).
Oral/axillary temperature superior or equal to 37.5°C (or 37 °C in Czech Republic).
Pregnant or lactating female
Clareo Health | A Study to Compare the Immune Response and Safety Elicited by Henogen's Adjuvanted Hepatitis B Vaccine Compared to GSK Biologicals Adjuvanted Hepatitis B Vaccine in Pre-Dialysis and Dialysis Patients Who Have Not Been Exposed to Hepatitis B.
