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Home > Protocol Summaries: Compounds > Hepatitis B Vaccine, Recombinant > Protocol Summary for 101695 Ext. Mth30

Protocol Summary for 101695 Ext. Mth30

Protocol Summary
Protocol Id: 101695 Ext. Mth30
Secondary Ids:
  • 101696 Ext. Mth42
  • 101697 Ext. Mth54
  • 101698 Ext. Mth66
Title: Long-term study of immune response persistence of GSK Biologicals' 2-dose thiomersal-free Engerix™-B and 3-dose preservative-free Engerix™-B vaccines in subjects aged 11-15 yrs
Phase: phase 3
Acronym:
FDA Regulated Intervention?:
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?: no
Study Type: Interventional
Oversight Authority:
  • Australia: Human Research Ethics Committee
Collaborators:
  • N/A
Brief Summary: To evaluate the persistence of antibodies against hepatitis B at 30, 42, 54 and 66 months after the first dose of the hepatitis B primary vaccination course. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Detailed Description: All subjects who participated in the primary study, in which they received either 2 or 3 doses of GSK Biologicals hepatitis B vaccine, and who consented to participate in the long-term follow-up at Month 42 were contacted by the investigators. No additional subjects will be recruited during this long-term follow-up study and no vaccine will be administered.
Record Verification Date: November 2011
Status: Completed
Why Study Stopped:
Study Start Date: April 2004
Study Completion Date: January 2008
Study Completion Date Type: None
Primary Completion Date: January 2008
Primary Completion Date Type: Actual
Primary Purpose: prevention
Allocation: Non-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:
  • Anti-hepatitis B surface antigen (anti-HBs) antibody concentrations At Months 30, 42, 54 & 66
Secondary Outcomes:
  • Occurrence of serious adverse events determined by the investigators to have a causal relationship to vaccination or to study procedures At Months 30, 42, 54 & 66
Conditions:
  • Prophylaxis hepatitis B
Keywords:
  • Persistence
  • Hepatitis B vaccine
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 13 Year
Maximum Age: 20 Year
Enrollment: 267
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: Click to view location information