Status:
COMPLETED
Immunogenicity and Safety of a Novel Adjuvanted HBV Vaccine in Pre-liver Transplant Patients 18 Years of Age
Lead Sponsor:
GlaxoSmithKline
Conditions:
Hepatitis B
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to enroll pre-liver transplant patients who will be vaccinated with either the novel adjuvanted HBV vaccine or double doses of Engerix™-B. The immunogenicity and safety of...
Detailed Description
At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham
Eligibility Criteria
Inclusion
- A male or female ≥ 18 years of age at the time of the first vaccination.
- Written informed consent obtained from the subject.
- Seronegative for anti-HBs-antibodies, anti-HBc-antibodies \& HBsAg.
- If the subject is female, she must be of non-childbearing potential or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.
- Documented case of liver failure, such that the patient will require an eventual liver transplant
Exclusion
- Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine.
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine and ending 30 days after.
- Previous vaccination against hepatitis B (whether or not a non-responder to vaccination).
- Previous vaccination with an adjuvant system containing MPL®.
- History of hepatitis B infection.
- Known exposure to hepatitis B virus within 6 weeks.
- Previously confirmed human immunodeficiency virus (HIV) infection.
- A family history of congenital or hereditary immunodeficiency.
- Immunosuppression caused by the administration of parenteral steroids or chemotherapy.
- Suspected or confirmed multiple sclerosis in the subject (applicable to Centres 011, 012, 013 and 014/ France only).
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Acute, intercurrent disease at the time of enrollment.
- Oral/axillary temperature of ≥ 37.5°C (≥ 99.5°F).
- Administration of immunoglobulins and/or any blood products within one month preceding the first dose of study vaccine or planned administration/ administration during the study period.
- Pregnant or lactating female
Key Trial Info
Start Date :
January 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT00697554
Start Date
January 1 2000
Last Update
September 9 2016
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