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Safety and Efficacy of SmithKline Beecham (GlaxoSmithKline [GSK]) Biologicals' Candidate Adjuvanted Vaccines (287615)

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: NCT00508833
Recruitment Status : Completed
First Posted : July 30, 2007
Last Update Posted : July 30, 2007
Information provided by:

Brief Summary:
This study was done to evaluate the effect of various adjuvants in combination with HBsAg as a model antigen on the induction of immune responses, mainly cytotoxic T lymphocytes (CTL) in healthy volunteers. The study was also done to evaluate the safety and reactogenicity of the various adjuvanted vaccines.

Condition or disease Intervention/treatment Phase
Hepatitis B Disease Biological: 287615 containing HBsAg with adjuvants Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Safety and the Efficacy of GSK Biologicals' Candidate Adjuvanted Vaccines (287615) Containing HBsAg With Various Adjuvants to Induce Cytotoxic T Lymphocytes (CTL) in Healthy Adult Volunteers
Study Start Date : March 2000

Primary Outcome Measures :
  1. Intensity of the CTL response at Week 6

Secondary Outcome Measures :
  1. Solicited symptoms (7 days), other AEs (up to 6 mths), SAEs (entire study), intensity of CTL response at Week 46, 48, 78; anti-HBs response up to week 78

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy volunteers between 18 and 40 years of age
  • Written informed consent obtained from subject
  • Female of non-childbearing potential

Exclusion Criteria:

  • Any hepatitis B vaccination.
  • Positive HBV serological markers: anti-HBs, anti-HBc, and/ or HBsAg
  • Pregnancy or lactating female
  • Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days or 7 half-lives (whichever is the longer) preceding the first vaccine administration

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): NCT00508833

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GSK Clinical Trials Call Center
Gent, Belgium
Sponsors and Collaborators
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Study Director: Clinical Trials GlaxoSmithKline

Layout table for additonal information Identifier: NCT00508833    
Other Study ID Numbers: 287615/005
First Posted: July 30, 2007    Key Record Dates
Last Update Posted: July 30, 2007
Last Verified: July 2007
Keywords provided by GlaxoSmithKline:
Additional relevant MeSH terms:
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Hepatitis B
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Immunologic Factors
Physiological Effects of Drugs