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Home > Protocol Summaries: Compounds > Hepatitis B Vaccine, Recombinant > Protocol Summary for 100450

Protocol Summary for 100450

Protocol Summary
Protocol Id: 100450
Secondary Ids:
  • N/A
Title: Long-Term Follow-up Study at Years 16, 17, 18, 19 and 20, to Evaluate the Persistence of Immune Response of GlaxoSmithKline Biologicals' Hepatitis B Vaccine Administered With or Without HBIG in Newborns of HBeAg+ 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: To evaluate the persistence of anti-HBs antibodies up to 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. No additional subjects will be recruited during this long-term follow-up study and no vaccine will be administered.
Detailed Description: The primary study was to evaluate the reactogenicity, immunogenicity and protective efficacy of a hepatitis B vaccine in healthy neonates of HBeAg positive mothers if administered with or without a dose of HBIg at birth. The current study describes the long term follow up of these subjects between Y16 and 20 after primary vaccination.
Record Verification Date: February 2011
Status: Completed
Why Study Stopped:
Study Start Date: October 2003
Study Completion Date: March 2010
Study Completion Date Type: Actual
Primary Completion Date: March 2010
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:
  • Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration Year 20
  • Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Years 16, 17, 18 and 19
  • Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration Years 16, 17, 18 and 19
  • Clinical Review of Hepatitis B Infection Status Over the entire follow up period (Final assessment of clinical significance will be analyzed after the Year 20)
  • Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection Years 16, 17, 18 and 19
  • Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Year 20
  • Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection Year 20
Secondary Outcomes:
  • Not applicable
Conditions:
  • Hepatitis B
Keywords:
  • Hepatitis B immunoglobulin
  • Hepatitis B antibody persistence
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 16 Year
Maximum Age: 20 Year
Enrollment: 79
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