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Protocol Summary for 208129/031

Protocol Summary
Protocol Id: 208129/031
Secondary Ids:
Title: Safety and immunogenicity of 3 lots of GSK Biologicals’ novel adjuvanted hepatitis B vaccine, administered according to a 2 dose schedule, and Engerix™-B administered according to a 3 dose schedule to healthy volunteers ≥ 15 years of age
Phase: Phase 3
Acronym:
FDA Regulated Intervention?:
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?: No
Study Type: Interventional
Oversight Authority:
  • Czech Republic: State Institute for Drug Control
Collaborators:
Brief Summary: This study was conducted to evaluate the lot-to-lot consistency of three lots of HBV-MPL vaccine and to compare their safety and immunogenicity with that of 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: September 2009
Status: Completed
Why Study Stopped:
Study Start Date: April 1999
Study Completion Date:
Study Completion Date Type: None
Primary Completion Date: February 2000
Primary Completion Date Type: Actual
Primary Purpose: Prevention
Allocation: Randomized
Masking: Single Blind
Masked Subject: true
Masked Caregiver: false
Masked Investigator: false
Masked Assessor: false
Study Design (Assignment): Parallel Assignment
Study Classification (Endpoint): Safety/Efficacy Study
Primary Outcomes:
  • Occurrence, intensity and causal relationship of any (solicited/unsolicited adverse event) general symptoms Full course of vaccination
  • Incidence of serious adverse events Study period
  • Anti-HBs antibody concentrations At Month 7
Secondary Outcomes:
  • Occurrence and intensity of solicited local signs and symptoms 4-day after vaccination
  • Occurrence, intensity and relationship to vaccination of solicited general signs and symptoms 4-day after vaccination
  • Occurrence, intensity and relationship to vaccination of unsolicited signs and symptoms 30 days after vaccination
  • Occurrence and relationship to vaccination of SAEs During the study period
  • Anti-HBs antibody concentrations At Months 1, 2, 6 and 7
Conditions:
  • Hepatitis B
Keywords:
  • Hepatitis B
  • Adjuvanted Hepatitis B vaccine
  • Recombinant Hepatitis B vaccine
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 15 Years
Maximum Age: N/A
Enrollment: 1303
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.