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Immunogenicity and Safety of GSK Biologicals' HBV-MPL Vaccine (2 Doses), and of Engerix™-B (3 Doses) in Healthy Adults

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00697853
First received: June 12, 2008
Last updated: June 13, 2008
Last verified: June 2008
History of Changes
  Purpose

This study is undertaken to assess the immune response and safety profile of 4 lots of the novel adjuvanted hepatitis B vaccine that were formulated following different processes, with Engerix™-B as the control vaccine


Condition Intervention Phase
Hepatitis B
 Biological: Engerix™-B
Biological: HBV-MPL vaccine 208129
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Study to Evaluate the Immunogenicity and Safety of GSK Biologicals' Novel Adjuvanted Hepatitis B Vaccine Administered According to a 0, 6 Month Schedule and of Engerix™-B Administered According to a 0, 1, 6 Month Schedule in Healthy Adults

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 and 6 ]
  • Occurrence and intensity of solicited local and general symptoms [ Time Frame: 4-day follow-up period after each vaccination ]
  • Occurrence, intensity and relationship to vaccination of unsolicited symptoms [ Time Frame: 30-day follow-up period after each vaccination ]
  • Occurrence, intensity and relationship to vaccination of SAEs [ Time Frame: Throughout the entire study ]

Enrollment: 200
Study Start Date: November 1998
Primary Completion Date: July 1999 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group A Biological: Engerix™-B
3-dose intramuscular injection
Experimental: Group B Biological: HBV-MPL vaccine 208129
2-dose intramuscular injection
Experimental: Group C Biological: HBV-MPL vaccine 208129
2-dose intramuscular injection
Experimental: Group D Biological: HBV-MPL vaccine 208129
2-dose intramuscular injection
Experimental: Group E Biological: HBV-MPL vaccine 208129
2-dose intramuscular injection

Detailed Description:

This is an open, randomized study with five groups, but the four groups receiving HBV-MPL candidate vaccine are double-blinded.

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

  Eligibility

Ages Eligible for Study:   15 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • A male or female between 15 and 50 years of age at the time of the first vaccination.
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study.
  • Written informed consent obtained from the subject and/or from the parents or guardians of the subject.
  • If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or use adequate contraceptive precautions for one month prior to vaccination and up to two months after the last vaccination

Exclusion Criteria:

  • Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine.
  • Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of vaccination.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine and ending 30 days after.
  • Previous vaccination against hepatitis B.
  • History of significant and persisting hematological, hepatic, renal, cardiac or respiratory disease.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
  • A family history of congenital or hereditary immunodeficiency.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Acute disease at the time of enrollment.
  • Hepatomegaly, right upper quadrant abdominal pain or tenderness.
  • Oral temperature of ≥37.5°C (99.5°F).
  • Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration/ administration during the study period.
  • Pregnant or lactating female.
  • History of chronic alcohol consumption and/or intravenous drug abuse
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00697853

Locations
Belgium
GSK Clinical Trial Call Center
Brussels, Belgium
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Isabelle Harpigny, GSK
ClinicalTrials.gov Identifier: NCT00697853     History of Changes
Other Study ID Numbers: 208129/030
Study First Received: June 12, 2008
Last Updated: June 13, 2008
Health Authority: Belgium: Institutional Review Board

Keywords provided by GlaxoSmithKline:
Hepatitis B
Adjuvanted hepatitis B vaccine
Recombinant hepatitis B vaccine

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 19, 2013