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Home > Protocol Summaries: Compounds > Hepatitis B Vaccine, Recombinant > Protocol Summary for 100449

Protocol Summary for 100449

Protocol Summary
Protocol Id: 100449
Secondary Ids:
  • N/A
Title: Long-term Follow-Up studies at Years 16-20, to evaluate the persistence of immune response of GSK Biologicals’ hepatitis B vaccine in newborns of HBeAg+ and HBsAg+ mothers in comparison with a historical control group
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: This study is performed to evaluate the persistence of anti-hepatitis B surface antigen (HBs) antibodies up to 16, 17, 18, 19 and 20 years after administration of the first dose of the study vaccine, Engerix-B™. No new subjects will be recruited in this long-term follow-up study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Detailed Description: The primary study was to evaluate the immunogenicity and protective efficacy of hepatitis B vaccine administered according to a 0, 1, 2, 12 month schedule in newborns of anti-hepatitis B envelope antigen positive (HBeAg+) and anti-hepatitis B surface antigen positive (HBsAg+) mothers. Results from the primary study have shown that the vaccine was immunogenic and protected neonates of HBeAg positive mothers against hepatitis B chronic carriage. The present study is carried out to evaluate the anti-HBs persistence and the prevalence and incidence of other hepatitis B markers (HBsAg, anti-hepatitis B core antigen {anti-HBc}, HBeAg, Alanine aminotransferase/Aspartate aminotransferase {ALT/AST}), and the clinical significance of the HBsAg and anti-HBc positive cases observed during the long-term from year 16-20. No vaccine will be administered during the long term follow up period.
Record Verification Date: October 2009
Status: Completed
Why Study Stopped:
Study Start Date: October 2003
Study Completion Date: July 2008
Study Completion Date Type: Actual
Primary Completion Date: July 2008
Primary Completion Date Type: Actual
Primary Purpose: prevention
Allocation: Non-randomized
Masking: Open Label
Masked Subject:
Masked Caregiver:
Masked Investigator:
Masked Assessor:
Study Design (Assignment): Parallel Assignment
Study Classification (Endpoint): Efficacy Study
Primary Outcomes:
  • Number of Subjects Seropositive for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies no At Years 16, 17, 18, 19 and 20 after primary vaccination
  • Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus no At Years 16, 17, 18, 19 and 20 after primary vaccination
  • Number of Subjects With Chronic and With Clinical HBV Infection no From year 16 through to year 20
Secondary Outcomes:
  • NOT APPLICABLE
Conditions:
  • Hepatitis B
Keywords:
  • Hepatitis B
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 16 Year
Maximum Age: 20 Year
Enrollment: 36
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