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Protocol Summary for 208129/021

Protocol Summary
Protocol Id: 208129/021
Secondary Ids:
Title: Study to compare the immunogenicity and reactogenicity of GSK Biologicals; (previously SmithKline Beecham Biologicals') MPL-adjuvanted recombinant hepatitis B vaccine with that of Engerix™-B in an adult non-responder population
Phase: Phase 3
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 compare the immunogenicity and reactogenicity of the adjuvanted recombinant hepatitis B vaccine with that of Engerix™-B when both are injected according to a three dose schedule (0, 1, 6 months) in an adult non-responder population
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: May 1997
Study Completion Date: June 1998
Study Completion Date Type: Actual
Primary Completion Date: June 1998
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 7
Secondary Outcomes:
  • Anti-HBs antibody concentrations At months 2, 6, 7 and 12
  • Occurrence and intensity of solicited local symptoms 4-day follow-up after vaccination
  • Occurrence, intensity and relationship of solicited general symptoms 4-day follow-up after vaccination
  • Occurrence, intensity and relationship to vaccination of unsolicited symptoms Within 30 days after vaccination
  • Incidence of serious AEs Throughout the entire study up to and including 30 days after the last vaccination
  • Cell mediated immunity At months 0, 2, 6, 7, 12
Conditions:
  • Hepatitis B
Keywords:
  • Hepatitis B
  • Engerix™-B
  • Recombinant Hepatitis B vaccine
  • Adjuvant
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 18 Years
Maximum Age: N/A
Enrollment: 116
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.