Immunogenicity and Safety of a Novel Adjuvanted HBV Vaccine in Pre-Liver Transplant Patients 18 Years of Age

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00697554
First received: June 12, 2008
Last updated: June 13, 2008
Last verified: June 2008

June 12, 2008
June 13, 2008
January 2000
May 2002   (final data collection date for primary outcome measure)
Anti-HBs antibody concentrations [ Time Frame: At Day 28 ]
Same as current
Complete list of historical versions of study NCT00697554 on ClinicalTrials.gov Archive Site
  • Occurrence, intensity and relationship to vaccination of solicited local and general signs and symptoms [ Time Frame: During a 4 day follow-up period after vaccination ]
  • Occurrence, intensity and relationship to vaccination of unsolicited symptoms [ Time Frame: During a 30 day follow-up period after vaccination ]
  • Occurrence, intensity and relationship to vaccination of serious adverse events (SAEs) [ Time Frame: During the study period ]
  • Anti-HBs antibody concentrations [ Time Frame: At d21, d28, d56, M6-12, 1M after booster dose ]
Same as current
Not Provided
Not Provided
 
Immunogenicity and Safety of a Novel Adjuvanted HBV Vaccine in Pre-Liver Transplant Patients 18 Years of Age
Study to Compare the Immunogenicity and Safety of GSK Biologicals' Novel Adjuvanted HBV Vaccine (0, 21-Day Schedule) to a Double Dose of Engerix™ -B (0, 7, 21-Day Schedule), in Pre-Liver Transplant Patients ≥ 18 y, Boosted at Month 6-12

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 the novel adjuvanted vaccine will be compared to Engerix™-B as the control vaccine

At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Hepatitis B
  • Biological: HBV-MPL vaccine 208129
    2-dose primary vaccination followed by 1 booster vaccination by intramuscular injection
  • Biological: Engerix™-B
    3-dose primary vaccination followed by 1 booster vaccination by intramuscular injection of double doses
  • Experimental: Group A
    Intervention: Biological: HBV-MPL vaccine 208129
  • Active Comparator: Group B
    Intervention: Biological: Engerix™-B
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
93
Not Provided
May 2002   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   France,   Germany,   Spain,   United Kingdom
 
NCT00697554
208129/036
Not Provided
Isabelle Harpigny, GSK
GlaxoSmithKline
Not Provided
Study Director: Clinical Trials GlaxoSmithKline
GlaxoSmithKline
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP