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Protocol Summary for 208129/028

Protocol Summary
Protocol Id: 208129/028
Secondary Ids:
Title: Study to assess the feasibility of GSK Bio's candidate HBV / MPL vaccines following different schedules and formulations and to compare their safety and immunogenicity to that of Engerix™-B in healthy adolescents aged 11 to 15
Phase: Phase 2
Acronym:
FDA Regulated Intervention?:
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?: No
Study Type: Interventional
Oversight Authority:
  • Germany: Ministry of Health
Collaborators:
Brief Summary: In this study the safety and immunogenicity of 2 different formulations of the candidate HBV-MPL vaccine administered according to a 0, 6-month schedule were explored and compared to that of Engerix™-B in healthy adolescents aged 11 to 15
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 1998
Study Completion Date:
Study Completion Date Type: None
Primary Completion Date: May 1999
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): Safety/Efficacy Study
Primary Outcomes:
  • Occurrence of Serious adverse experiences (SAE) During the study period
  • Occurrence, intensity and relationship to vaccination of solicited local and general symptoms During the 8-day follow-up period after vaccination
  • Occurrence, intensity and causal relationship of unsolicited adverse events 31-day follow-up period after vaccination
Secondary Outcomes:
  • Anti-HBs antibody concentrations At months 1, 2, 6, and 7
  • Cell mediated immunity At months 1, 6, and 7
Conditions:
  • Hepatitis B
Keywords:
  • Hepatitis B
  • Recombinant hepatitis B vaccine
  • Adjuvant
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 11 Years
Maximum Age: 15 Years
Enrollment: 200
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.