Status:
COMPLETED
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.
Lead Sponsor:
Henogen
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Hepatitis B
Eligibility:
All Genders
15+ years
Phase:
PHASE3
Brief Summary
The pre-dialysis, peritoneal dialysis and haemodialysis patients would benefit from an improved hepatitis B vaccine, which will elicit stronger and faster cellular and humoral immune responses after t...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00291941
Start Date
February 1 2006
End Date
March 1 2007
Last Update
August 28 2008
Active Locations (24)
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1
O.L.Vrouwziekenhuis Aalst
Aalst, Belgium, 9300
2
RHMS La Madeleine ATH
Ath, Belgium, 7800
3
RHMS Clinique Louis Caty Baudour
Baudour, Belgium, 7331
4
AZ -VUB Dienst Nefrologie
Brussels, Belgium, 1090