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Protocol Summary for 208129/009

Protocol Summary
Protocol Id: 208129/009
Secondary Ids:
Title: Study to compare the immunogenicity, safety and reactogenicity of GSK Biologicals’ (previously SmithKline Beecham Biologicals') recombinant hepatitis B vaccines with and without adjuvant in healthy older adult volunteers
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
  • Denmark: National Board of Health
  • Austria: Ethikkommission
  • Ireland: Ministry of Health
Collaborators:
Brief Summary: In the present study the immunogenicity, reactogenicity and safety of recombinant hepatitis B vaccines with and without MPL will be evaluated in older healthy subjects
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 1994
Study Completion Date: November 1995
Study Completion Date Type: Actual
Primary Completion Date: November 1995
Primary Completion Date Type: Actual
Primary Purpose: Prevention
Allocation: Randomized
Masking: Double Blind
Masked Subject: true
Masked Caregiver: true
Masked Investigator: true
Masked Assessor: false
Study Design (Assignment): Parallel Assignment
Study Classification (Endpoint): Safety/Efficacy Study
Primary Outcomes:
  • Anti-hepatitis B surface antigen (HBs) antibody concentrations At M2 and M7
Secondary Outcomes:
  • Anti-pre-S1 antibody concentrations Screening, Months 1, 2, 3, 6, 7, 8 and 12, depending on group allocation
  • Anti-HBs antibody concentrations Screening, Months 1, 2, 3, 6, 7, 8 and 12
  • Occurrence and intensity of local and general solicited symptoms 4-day after vaccination
  • Cell mediated immunity Month 0, Month 2 and month 7
  • Occurrence of unsolicited adverse events 30 days after vaccination
  • Occurrence of serious adverse events During the study period and 30 days after last vaccine dose
Conditions:
  • Hepatitis B
Keywords:
  • Hepatitis B
  • Engerix™-B
  • Recombinant Hepatitis B vaccine
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 50 Years
Maximum Age: 70 Years
Enrollment: 362
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.