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Protocol Summary for 208129/033

Protocol Summary
Protocol Id: 208129/033
Secondary Ids:
  • 208129/038
Title: A study to compare the immunogenicity and safety of GSK Biologicals adjuvanted HBV vaccine to Engerix™-B, in a non-responder population ≥ 15 years of age, when administered intramuscularly, according to a 0, 1, 2, 12 month schedule
Phase: phase 3
Acronym:
FDA Regulated Intervention?:
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?: no
Study Type: Interventional
Oversight Authority:
  • Spain: Ministry of Health
  • Belgium: Institutional Review Board
Collaborators:
Brief Summary: Subjects who had not responded to previous hepatitis B vaccination were vaccinated with either the adjuvanted HBV-MPL vaccine or Engerix™-B vaccine according to a three-dose vaccination schedule (0, 1, 2 months) and boosted at Month 12 as per their group allocation. The immunogenicity and safety of the HBV-MPL vaccine were compared with the control vaccine, Engerix™-B.
Detailed Description: At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham.
Record Verification Date: July 2010
Status: Completed
Why Study Stopped:
Study Start Date: November 1999
Study Completion Date: May 2001
Study Completion Date Type: Actual
Primary Completion Date: September 2000
Primary Completion Date Type: Actual
Primary Purpose: prevention
Allocation: Randomized
Masking: Single Blind
Masked Subject: yes
Masked Caregiver: no
Masked Investigator: no
Masked Assessor: no
Study Design (Assignment): Parallel Assignment
Study Classification (Endpoint): Safety/Efficacy Study
Primary Outcomes:
  • Anti-HBs antibody concentrations Months 1, 2 and 3
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 signs and 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, up to and including 6 months post-vaccination
  • Anti-HBs antibody concentrations in all subjects Months 1, 2, 3, 12 and 13
Conditions:
  • Hepatitis B
Keywords:
  • Hepatitis B
  • Adjuvanted vaccine
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 15 Year
Maximum Age:
Enrollment: 145
Enrollment Type: Actual
Healthy Volunteers?: yes
Central Contact:
Central Contact Phone:
Central Contact Email:
Backup Central Contact:
Backup Central Contact Phone:
Backup Central Contact Email:
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.