Evaluation of Immunogenicity, Reactogenicity and Safety of HBV-MPL Vaccine vs Engerix™-B, in Haemodialysis Patients

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00699231
First received: June 13, 2008
Last updated: June 16, 2008
Last verified: June 2008

June 13, 2008
June 16, 2008
February 1992
December 1992   (final data collection date for primary outcome measure)
  • Occurrence and intensity of solicited local and general symptoms [ Time Frame: 4-day follow-up period after each vaccination ]
  • Occurrence of unsolicited adverse events [ Time Frame: During the course of the study ]
  • Occurrence of serious adverse events [ Time Frame: During the course of the study ]
  • Anti-HBs antibody concentrations [ Time Frame: Pre, Day 0, Day 30, Day 60, Day 90, Day 120, D180, D210 depending on group allocation ]
Same as current
Complete list of historical versions of study NCT00699231 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Evaluation of Immunogenicity, Reactogenicity and Safety of HBV-MPL Vaccine vs Engerix™-B, in Haemodialysis Patients
Study to Evaluate the Immunogenicity, Reactogenicity and Safety of GSK Biologicals' (Previously SmithKline Beecham Biologicals') MPL-Adjuvanted Recombinant Hepatitis B Vaccine Versus Engerix™-B, in Haemodialysis Patients

This trial is designed to evaluate the immunogenicity, reactogenicity and safety of an MPL-adjuvanted recombinant hepatitis B vaccine in comparison with those of Engerix™-B in haemodialysis patients with or without previous vaccination against hepatitis B

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

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Hepatitis B
  • Biological: HBV-MPL vaccine 208129
    IM injection
  • Biological: Engerix™-B
    IM injection
  • Active Comparator: Group A1
    Non-responders to vaccination after at least 7 previous injections
    Intervention: Biological: Engerix™-B
  • Experimental: Group A2
    Non-responders to vaccination after at least 7 previous injections
    Intervention: Biological: HBV-MPL vaccine 208129
  • Active Comparator: Group B1
    Vaccine-responders requiring a booster dose
    Intervention: Biological: Engerix™-B
  • Experimental: Group B2
    Vaccine-responders requiring a booster dose
    Intervention: Biological: HBV-MPL vaccine 208129
  • Active Comparator: Group C1
    Volunteers participating in the hospital's vaccination program
    Intervention: Biological: Engerix™-B
  • Experimental: Group C2
    Volunteers participating in the hospital's vaccination program
    Intervention: Biological: HBV-MPL vaccine 208129
  • Active Comparator: Group D1
    Unvaccinated haemodialysis patients
    Intervention: Biological: Engerix™-B
  • Experimental: Group D2
    Unvaccinated haemodialysis patients
    Intervention: Biological: HBV-MPL vaccine 208129
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
December 1992
December 1992   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Dialysis patients
  • A medical examination including physical examination and medical history as well as serological screening established acceptability for enrollment into the study.
  • Age: from 18 years onwards
  • Seronegative for anti- hepatitis antibodies

Exclusion Criteria:

  • History of persistent hepatic, cardiac or respiratory disease
  • Any acute disease at the moment of entry into the study
  • Chronic alcohol consumption
  • Hepatomegaly, right upper quadrant pain or tenderness
  • Any treatment with coticosteroids or immunomodulating drugs
  • Known hypersensitivity to any component of the vaccine
  • Simultaneous participation in any other clinical trial
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00699231
208129/002
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