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Protocol Summary for 208129/004

Protocol Summary
Protocol Id: 208129/004
Secondary Ids:
Title: Study to evaluate the immunogenicity and reactogenicity of GSK Biologicals' MPL-adjuvanted recombinant hepatitis B vaccine in comparison with those of Engerix™-B in healthy adult volunteers following 2 different schedules
Phase: Phase 2
Acronym:
FDA Regulated Intervention?:
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?: No
Study Type: Interventional
Oversight Authority:
  • Belgium: Ministry of Social Affairs, Public Health and the Environment
Collaborators:
Brief Summary: The purpose of this study is to evaluate the safety, immunogenicity and reactogenicity of MPL-adjuvanted recombinant hepatitis B vaccine in comparison with those of Engerix™-B in healthy adult volunteers following two different schedules: 0, 2 months and 0, 6 months
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: September 1992
Study Completion Date: December 1998
Study Completion Date Type: Actual
Primary Completion Date: May 1996
Primary Completion Date Type: Actual
Primary Purpose: Prevention
Allocation: Randomized
Masking: Double Blind
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-hepatitis B surface antigen (HBs) antibody concentrations One month after the full primary vaccination course and one month after the booster vaccination at 70 months
Secondary Outcomes:
  • Anti-HBs antibody concentrations Months 1, 2, 3, 6, 12, 13, 42
  • Serious adverse experiences (SAE). Throughout the study period
  • Occurrence and intensity of solicited local symptoms 8-day follow-up after vaccination
  • Occurrence, intensity and relationship of solicited general symptoms 8-day follow-up after vaccination
  • Incidence of unsolicited symptoms During the 30-day follow-up after vaccination
Conditions:
  • Hepatitis B
Keywords:
  • Hepatitis B
  • Engerix™-B
  • Recombinant hepatitis B vaccine
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 18 Years
Maximum Age: 40 Years
Enrollment: 99
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.