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Protocol Summary for 208129/036

Protocol Summary
Protocol Id: 208129/036
Secondary Ids:
Title: Study to compare the immunogenicity and safety of GSK Biologicals’ novel adjuvanted HBV vaccine (0, 21-day schedule) to a double dose of Engerix™ -B (0, 7, 21-day schedule), in pre-liver transplant patients ≥ 18 y, boosted at month 6-12
Phase: Phase 3
Acronym:
FDA Regulated Intervention?:
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?: No
Study Type: Interventional
Oversight Authority:
  • Germany: Ministry of Health
  • United Kingdom: National Health Service
  • Belgium: Institutional Review Board
  • Spain: Ministry of Health
  • France: Ministry of Health
Collaborators:
Brief Summary: The purpose of this study is to enroll pre-liver transplant patients who will be vaccinated with either the novel adjuvanted HBV vaccine or double doses of Engerix™-B. The immunogenicity and safety of the novel adjuvanted vaccine will be compared to Engerix™-B as the control vaccine
Detailed Description: 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: January 2000
Study Completion Date:
Study Completion Date Type: None
Primary Completion Date: May 2002
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 Day 28
Secondary Outcomes:
  • Occurrence, intensity and relationship to vaccination of solicited local and general signs and symptoms During a 4 day follow-up period after vaccination
  • Occurrence, intensity and relationship to vaccination of unsolicited symptoms During a 30 day follow-up period after vaccination
  • Occurrence, intensity and relationship to vaccination of serious adverse events (SAEs) During the study period
  • Anti-HBs antibody concentrations At d21, d28, d56, M6-12, 1M after booster dose
Conditions:
  • Hepatitis B
Keywords:
  • Hepatitis B
  • Adjuvanted hepatitis B vaccine
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 18 Years
Maximum Age: N/A
Enrollment: 93
Enrollment Type: Actual
Healthy Volunteers?: No
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.