Study Comparing Immunogenicity, Reactogenicity and Safety of GSK Bios' HBV-MPL Vaccine With That of Engerix™-B in Adults

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. Identifier: NCT00696891
Recruitment Status : Completed
First Posted : June 13, 2008
Last Update Posted : June 13, 2008
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Brief Summary:
This study is conducted to compare the immunogenicity, reactogenicity and safety of Engerix™-B and HBV-MPL vaccine against hepatitis B infection in an elderly population

Condition or disease Intervention/treatment Phase
Hepatitis B Biological: HBV-MPL vaccine Biological: Engerix™-B Phase 3

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Study Comparing Immunogenicity, Reactogenicity and Safety of GSK Biologicals' HBV-MPL Vaccine With That of Engerix™-B When Both Are Injected According to 3 Dose Schedule (0, 1, 6 Months) in an Adult Population Aged Between 50 and 70 Years
Study Start Date : June 1997
Actual Primary Completion Date : May 1999

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Group A Biological: HBV-MPL vaccine
3-dose intramuscular injection
Active Comparator: Group B Biological: Engerix™-B
3-dose intramuscular injection

Primary Outcome Measures :
  1. Anti-HBs antibody concentrations [ Time Frame: At Month 7 ]

Secondary Outcome Measures :
  1. Anti-HBs antibody concentrations [ Time Frame: At Months 1, 2, 6, 7 and 12 ]
  2. Occurrence and intensity of solicited local symptoms [ Time Frame: 4-day follow-up after vaccination ]
  3. Occurrence and intensity and relationship to vaccination of solicited general symptoms [ Time Frame: 4-day follow-up after vaccination ]
  4. Occurrence and intensity of any symptoms (solicited/ unsolicited). [ Time Frame: 4-day follow-up after vaccination ]
  5. Occurrence, intensity and causal relationship of unsolicited symptoms [ Time Frame: Within 30 days after vaccination ]
  6. Serious adverse events [ Time Frame: Throughout study period ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Age: 50 to 70 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 at screening for anti-HBV 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 recombinant hepatitis B vaccine.
  • Previous vaccination with an MPL containing vaccine.
  • Administration of immunoglobulins in the past 6 months and during the whole study period
  • Vaccination one week before and one week after each dose of the study vaccine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00696891

GSK Clinical Trials Call Center
Wilrijk, Belgium
GSK Clinical Trials Call Center
Toronto, Canada
GSK Clinical Trials Call Center
Göteborg, Sweden
Sponsors and Collaborators
Study Director: Clinical Trials GlaxoSmithKline

Responsible Party: Isabelle Harpigny, GSK Identifier: NCT00696891     History of Changes
Other Study ID Numbers: 208129/022
First Posted: June 13, 2008    Key Record Dates
Last Update Posted: June 13, 2008
Last Verified: June 2008

Keywords provided by GlaxoSmithKline:
Adjuvanted hepatitis B vaccine, hepatitis B, Engerix™-B

Additional relevant MeSH terms:
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Immunologic Factors
Physiological Effects of Drugs