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Protocol Summary for 104387

Protocol Summary
Protocol Id: 104387
Secondary Ids:
Title: Demonstrate the non-inferiority of immunogenicity elicited by GSK Biologicals’ hepatitis B vaccine, multidose Engerix™-B to that of monodose Engerix™-B when administered according to 0,1,6 mths schedule in healthy adults aged ≥ 18 yrs
Phase: phase 4
Acronym:
FDA Regulated Intervention?:
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?: no
Study Type: Interventional
Oversight Authority:
  • Belgium: Directorate general for the protection of Public health: Medicines
Collaborators:
Brief Summary: GSK Biologicals' currently licensed multidose hepatitis B vaccine will be compared to the currently licensed monodose hepatitis B vaccine in a population with well documented hepatitis B immunological response to the vaccine (Belgium).
Detailed Description: Randomized study with two groups. One group will receive GSK's multidose hepatitis B vaccine and the other group will receive GSK's monodose hepatitis B vaccine
Record Verification Date: February 2011
Status: Completed
Why Study Stopped:
Study Start Date: March 2005
Study Completion Date: December 2005
Study Completion Date Type: Actual
Primary Completion Date: December 2005
Primary Completion Date Type: Actual
Primary Purpose: prevention
Allocation: Randomized
Masking: Single Blind
Masked Subject: no
Masked Caregiver: no
Masked Investigator: no
Masked Assessor: no
Study Design (Assignment): Parallel Assignment
Study Classification (Endpoint): Safety/Efficacy Study
Primary Outcomes:
  • Measurement of antibody concentrations to hepatitis B antigen at Month 7.
Secondary Outcomes:
  • Measurement of antibody concentrations to hepatitis antigen at Months 1,2and6. Occurrence of solicited local symptoms and solicited general symptoms during the 4-day f/u period after vaccination. Occurrence, intensity and relationship to vaccination
Conditions:
  • Hepatitis B
Keywords:
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 18 Year
Maximum Age:
Enrollment: 280
Enrollment Type:
Healthy Volunteers?: yes
Central Contact: Call Center
Central Contact Phone: 877-379-3718
Central Contact Email: GSKClinicalSupportHD@gsk.com
Backup Central Contact:
Backup Central Contact Phone:
Backup Central Contact Email:
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: Click to view location information