Quick Search

 

 


 

 

Protocol Summary for 208129/016

Protocol Summary
Protocol Id: 208129/016
Secondary Ids:
Title: Study to compare the safety, immunogenicity and reactogenicity of different formulations of GSK Biologicals' (previously SmithKline Beecham Biologicals') MPL-adjuvanted recombinant hepatitis B vaccine to that of Engerix™-B
Phase: Phase 3
Acronym:
FDA Regulated Intervention?:
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?: No
Study Type: Interventional
Oversight Authority:
  • Austria: Ethikkommission
Collaborators:
Brief Summary: The purpose of the study is to compare the safety, reactogenicity and immunogenicity of different formulations of adjuvanted recombinant hepatitis B vaccine to that of Engerix™-B when administered at 0, 2 months with a booster at month 12 if necessary
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 1995
Study Completion Date: February 1996
Study Completion Date Type: Actual
Primary Completion Date: February 1996
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-HBs antibody concentrations At M3 and M13
  • Occurrence of local and general solicited symptoms 4-day follow-up after vaccination
  • Occurrence of unsolicited symptoms 30-day follow-up after vaccination
Secondary Outcomes:
  • SAEs Throughout the study up to 30 days after last vaccination
  • Anti-HBs antibody concentrations Months 2, 3, 6, 9, 12, 13
Conditions:
  • Hepatitis B
Keywords:
  • Hepatitis B
  • Engerix™-B
  • Adjuvanted recombinant hepatitis B vaccine
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 18 Years
Maximum Age: 40 Years
Enrollment: 60
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.