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

This study has been completed.
Information provided by:
GlaxoSmithKline Identifier:
First received: June 11, 2008
Last updated: NA
Last verified: June 2008
History: No changes posted

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 Intervention Phase
Hepatitis B
Biological: HBV-MPL vaccine
Biological: Engerix™-B
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

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

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

Enrollment: 380
Study Start Date: June 1997
Primary Completion Date: May 1999 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A Biological: HBV-MPL vaccine
3-dose intramuscular injection
Active Comparator: Group B Biological: Engerix™-B
3-dose intramuscular injection

Detailed Description:

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


Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its identifier: 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
  More Information

No publications provided

Responsible Party: Isabelle Harpigny, GSK Identifier: NCT00696891     History of Changes
Other Study ID Numbers: 208129/022
Study First Received: June 11, 2008
Last Updated: June 11, 2008
Health Authority: Sweden: Medical Products Agency

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

Additional relevant MeSH terms:
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections processed this record on April 17, 2014