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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00696891
First received: June 11, 2008
Last updated: NA
Last verified: June 2008
History: No changes posted
  Purpose

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:

U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 ClinicalTrials.gov identifier: NCT00696891

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

No publications provided

Responsible Party: Isabelle Harpigny, GSK
ClinicalTrials.gov 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
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

ClinicalTrials.gov processed this record on May 23, 2013