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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.
ClinicalTrials.gov Identifier: NCT00508833
Recruitment Status : Completed
First Posted : July 30, 2007
Last Update Posted : July 30, 2007
Sponsor:
Information provided by:
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE July 27, 2007
First Posted Date  ICMJE July 30, 2007
Last Update Posted Date July 30, 2007
Study Start Date  ICMJE March 2000
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: July 27, 2007)
Intensity of the CTL response at Week 6
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 27, 2007)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of SmithKline Beecham (GlaxoSmithKline [GSK]) Biologicals' Candidate Adjuvanted Vaccines (287615)
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE Hepatitis B Disease
Intervention  ICMJE Biological: 287615 containing HBsAg with adjuvants
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: July 27, 2007)
200
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00508833
Other Study ID Numbers  ICMJE 287615/005
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP