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Comparing Immunogenicity and Safety of Different Formulations of HBV-MPL Vaccine With Engerix™-B in Adults Aged 19-40 y

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00698906
First Posted: June 17, 2008
Last Update Posted: June 17, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
GlaxoSmithKline
June 13, 2008
June 17, 2008
June 17, 2008
June 1997
February 1998   (Final data collection date for primary outcome measure)
Anti-HBs antibody concentrations [ Time Frame: Month 7 ]
Same as current
No Changes Posted
  • Anti-HBs antibody concentrations [ Time Frame: Month 1, 2 and 6 ]
  • Occurrence, intensity and relationship to vaccination of solicited local and general symptoms [ Time Frame: 4-day follow-up after vaccination ]
  • Occurrence, intensity and relationship to vaccination of unsolicited symptoms [ Time Frame: 31-day follow-up after vaccination ]
  • Incidence of serious adverse events [ Time Frame: During the study period ]
Same as current
Not Provided
Not Provided
 
Comparing Immunogenicity and Safety of Different Formulations of HBV-MPL Vaccine With Engerix™-B in Adults Aged 19-40 y
Study Comparing the Immunogenicity and Reactogenicity of Different Formulations of GSK Bio's HBV-MPL Vaccine Injected as a 0, 6 Months Schedule With That of Engerix™-B Injected as a 0, 1, 6 Months Schedule in Healthy Adults Aged 19-40 Years
This study will evaluate the immunogenicity and safety of different formulations of the HBV-MPL vaccine administered according to a 2-dose schedule and compare it to that of Engerix™-B administered according to a 3-dose schedule in order to determine the optimal dose of each component of the candidate HBV-MPL vaccine when administered at 0 and 6 months
At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Hepatitis B
  • Biological: HBV-MPL vaccine
    5 different formulations, 2-dose intramuscular injection
  • Biological: Engerix™-B
    3-dose intramuscular injection
  • Experimental: Group A
    Intervention: Biological: HBV-MPL vaccine
  • Experimental: Group B
    Intervention: Biological: HBV-MPL vaccine
  • Experimental: Group C
    Intervention: Biological: HBV-MPL vaccine
  • Experimental: Group D
    Intervention: Biological: HBV-MPL vaccine
  • Experimental: Group E
    Intervention: Biological: HBV-MPL vaccine
  • Active Comparator: Group F
    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
160
Not Provided
February 1998   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age: between 19 and 40 years old.
  • Good physical condition as established by clinical examination and history taking at the time of entry.
  • Female participants who are at risk to become pregnant will be on a contraceptive programme if necessary during the study period.
  • Written informed consent obtained from the subjects

Exclusion Criteria:

  • Positive titres at screening for anti-hepatitis antibodies.
  • Elevated serum liver enzymes.
  • History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
  • Any acute disease at the moment of entry.
  • Chronic alcohol consumption.
  • Hepatomegaly, right upper quadrant abdominal pain or tenderness.
  • Any chronic drug treatment, including any treatment with immunosuppressive drugs, which in the investigator's opinion, precludes inclusion into the study.
  • History of allergic disease likely to be stimulated by any component of the vaccine.
  • Simultaneous participation in any other clinical trial.
  • Previous vaccination with a hepatitis B vaccine.
  • Previous vaccination with an MPL containing vaccine.
  • Administration of immunoglobulins in the past 3 months and during the whole study period
  • Vaccination one month before and one month after each dose of the study vaccine
Sexes Eligible for Study: All
19 Years to 40 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Austria
 
 
NCT00698906
208129/026
Not Provided
Not Provided
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