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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00508833
First Posted: July 30, 2007
Last Update Posted: July 30, 2007
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.
Information provided by:
GlaxoSmithKline
  Purpose
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 Intervention Phase
Hepatitis B Disease Biological: 287615 containing HBsAg with adjuvants Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Further study details as provided by GlaxoSmithKline:

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 200
Study Start Date: March 2000
  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00508833


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

ClinicalTrials.gov Identifier: NCT00508833     History of Changes
Other Study ID Numbers: 287615/005
First Submitted: July 27, 2007
First Posted: July 30, 2007
Last Update Posted: July 30, 2007
Last Verified: July 2007

Keywords provided by GlaxoSmithKline:
Adjuvants
HBsAg

Additional relevant MeSH terms:
Hepatitis B
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Hepatitis
Liver Diseases
Digestive System Diseases