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Protocol Summary for 208129/037

Protocol Summary
Protocol Id: 208129/037
Secondary Ids:
Title: Evaluating the consistency of 3 consecutive lots of GSK Bio's novel adjuvanted HBV vaccine with single-blind safety evaluation using Engerix™-B as a control, administered according to a 0, 1, 2-mth schedule in healthy volunteers (15-50y).
Phase: Phase 3
Acronym:
FDA Regulated Intervention?:
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?: No
Study Type: Interventional
Oversight Authority:
  • Belgium: Institutional Review Board
  • Czech Republic: Ethics Committee
  • United Kingdom: National Health Service
  • Italy: Ethics Committee
  • France: Ministry of Health
Collaborators:
Brief Summary: The purpose of the present study is to evaluate the immunogenicity and safety of three consecutive production lots of the novel adjuvanted HBV vaccine. The safety of the candidate vaccine will be assessed using Engerix™-B as control.
Detailed Description: Double-blind for the identity of the consistency lots, single-blind for the control group/study vaccine identity. At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham
Record Verification Date: November 2009
Status: Completed
Why Study Stopped:
Study Start Date: August 2000
Study Completion Date:
Study Completion Date Type: None
Primary Completion Date: February 2001
Primary Completion Date Type: Actual
Primary Purpose: Prevention
Allocation: Randomized
Masking: Single Blind
Masked Subject: true
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 3
Secondary Outcomes:
  • Anti-HBs antibody concentrations At M1, M2, M3
  • Anti-RF1 antibody titres in a subset of 50 subjects per group At months 0 and 3
  • Occurrence, intensity and relationship to vaccination of solicited local and general signs and symptoms During a 4-day follow-up after vaccination
  • Occurrence, intensity and relationship to vaccination of unsolicited symptoms Within 30 days after each vaccination
  • Occurrence, intensity and relationship to vaccination of serious adverse events During the study period
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: 951
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.