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Home > Protocol Summaries: Compounds > Hepatitis B Vaccine, Recombinant > Protocol Summary for 100448

Protocol Summary for 100448

Protocol Summary
Protocol Id: 100448
Secondary Ids:
  • N/A
Title: Long-Term F-U Study at Yrs 16-20, to Evaluate the Persistence of Immune Response of GSK Biologicals' Hepatitis B Vaccine in Newborns of HBeAg+ and HBsAg+ Mothers
Phase: phase 4
Acronym:
FDA Regulated Intervention?: Yes
Section 801 Clinical Trial?: Yes
Delayed Posting: No
IND/IDE Protocol?: no
Study Type: Interventional
Oversight Authority:
  • Thailand: Ministry of Public Health
Collaborators:
  • N/A
Brief Summary: The purpose of this study is to evaluate the persistence of anti-hepatitis B surface antigen (anti-HBs) antibodies 16, 17, 18, 19 and 20 years after administration of the first dose of the study vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Detailed Description: The primary study was designed to evaluate the immunogenicity and protective efficacy of hepatitis B vaccine in newborns of HBeAg+ and HBsAg+ mothers in comparison with a historical control group. The present study is carried out to evaluate the anti-HBs persistence 16-20 years after the first vaccine dose and to further investigate the prevalence and incidence of other hepatitis B markers and the clinical significance of these at all time points from Year 16-20. No additional subjects will be recruited during this long-term follow-up study and no vaccine will be administered.
Record Verification Date:
Status: Completed
Why Study Stopped:
Study Start Date: October 2003
Study Completion Date: November 2007
Study Completion Date Type: Actual
Primary Completion Date: November 2007
Primary Completion Date Type: Actual
Primary Purpose: prevention
Allocation: Non-randomized
Masking: Open Label
Masked Subject: no
Masked Caregiver: no
Masked Investigator: no
Masked Assessor: no
Study Design (Assignment): Parallel Assignment
Study Classification (Endpoint): Efficacy Study
Primary Outcomes:
  • Prevalence of serological markers for hepatitis B infection Years 17, 18, 19 and 20.
  • Anti-hepatitis B surface antigen (anti-HBs) antibody concentrations Years 17, 18, 19 and 20.
  • Clinical review for hepatitis B infection status Over the entire 4 year follow up period (17 - 20 years)
Secondary Outcomes:
  • Not applicable
Conditions:
  • Hepatitis B Vaccine
  • Hepatitis B
Keywords:
  • Long-term follow-up
  • Hepatitis B antibody persistence
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 16 Year
Maximum Age: 20 Year
Enrollment: 109
Enrollment Type: Actual
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