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Protocol Summary for 208129/030

Protocol Summary
Protocol Id: 208129/030
Secondary Ids:
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
Phase: Phase 2
Acronym:
FDA Regulated Intervention?:
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?: No
Study Type: Interventional
Oversight Authority:
  • Belgium: Institutional Review Board
Collaborators:
Brief Summary: 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
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
Record Verification Date: September 2009
Status: Completed
Why Study Stopped:
Study Start Date: November 1998
Study Completion Date:
Study Completion Date Type: None
Primary Completion Date: July 1999
Primary Completion Date Type: Actual
Primary Purpose: Prevention
Allocation: Randomized
Masking: Open Label
Masked Subject: false
Masked Caregiver: false
Masked Investigator: false
Masked Assessor: false
Study Design (Assignment): Parallel Assignment
Study Classification (Endpoint): Safety/Efficacy Study
Primary Outcomes:
  • Anti-HBs antibody concentrations At month 7
Secondary Outcomes:
  • Anti-HBs antibody concentrations At months 1, 2 and 6
  • Occurrence and intensity of solicited local and general symptoms 4-day follow-up period after each vaccination
  • Occurrence, intensity and relationship to vaccination of unsolicited symptoms 30-day follow-up period after each vaccination
  • Occurrence, intensity and relationship to vaccination of SAEs Throughout the entire study
Conditions:
  • Hepatitis B
Keywords:
  • Hepatitis B
  • Adjuvanted hepatitis B vaccine
  • Recombinant hepatitis B vaccine
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 15 Years
Maximum Age: 50 Years
Enrollment: 200
Enrollment Type: Actual
Healthy Volunteers?: Yes
Central Contact: US GSK Clinical Trials Call Center
Central Contact Phone: 877-379-3718
Central Contact Email: GSKClinicalSupportHD@gsk.com
Backup Central Contact: EU GSK Clinical Trials Call Center
Backup Central Contact Phone: +44 (0) 20 8990 4466
Backup Central Contact Email: GSKClinicalSupportHD@gsk.com
Overall Study Official: GSK Clinical Trials
Overall Study Official Affiliation: GlaxoSmithKline
Overall Study Official Role: Study Director
Responsible Party Name/Official Title: Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization: GSK Clinical Disclosure
Location and Contact Information: No locations currently recruiting for this study.