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Protocol Summary for 208129/025

Protocol Summary
Protocol Id: 208129/025
Secondary Ids:
Title: Study comparing the immunogenicity and reactogenicity of different formulations of GSK Bio’s HBV-MPL vaccine injected as a 0, 6 months schedule with that of Engerix™-B injected as a 0, 1, 6 months schedule in healthy adults aged 18-40 years
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: This study will evaluate the immunogenicity and safety of different formulations of the candidate HBV-MPL vaccine administered according to a 2-dose schedule and compare it to that of Engerix™-B administered according to a 3-dose schedule in order to determine the optimal dose of each component of the candidate HBV-MPL vaccine when administered at 0 and 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: March 1997
Study Completion Date:
Study Completion Date Type: None
Primary Completion Date: May 1998
Primary Completion Date Type: Actual
Primary Purpose: Prevention
Allocation: Randomized
Masking: Open Label
Masked Subject: false
Masked Caregiver: false
Masked Investigator: false
Masked Assessor: false
Study Design (Assignment): Parallel Assignment
Study Classification (Endpoint): Efficacy Study
Primary Outcomes:
  • Anti-HBs antibody concentrations Month 7
Secondary Outcomes:
  • Anti-HBs antibody concentrations Month 1, 2, 6 and 12
  • Cell mediated immunity Month 1, 2, 6, 7 and 12
  • Occurrence and intensity and relationship to vaccination of solicited local and general symptoms 4-day follow-up after vaccination
  • Occurrence and intensity and relationship to vaccination of unsolicited symptoms 31-day follow-up after vaccination
  • Incidence of SAE Throughout the study period
Conditions:
  • Hepatitis B
Keywords:
  • Hepatitis B
  • HBV-MPL
  • Recombinant hepatitis B vaccine
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 18 Years
Maximum Age: 40 Years
Enrollment: 163
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.