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Protocol Summary for 110071

Protocol Summary
Protocol Id: 110071
Secondary Ids:
  • N/A
Title: Immune response to a hepatitis B vaccine challenge dose in healthy subjects who received primary vaccination of GlaxoSmithKline Biologicals' hepatitis B vaccine, approximately 20 years ago.
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: NA
Collaborators:
  • N/A
Brief Summary: In this study, subjects who received primary neonatal vaccination with hepatitis B vaccine at 0, 1, 2, 12 months, 20 years ago in the 103860/272 primary study will be evaluated for immunological memory to hepatitis B vaccine via assessment of the response to a vaccine challenge dose.
Detailed Description:
Record Verification Date: April 2009
Status: Completed
Why Study Stopped:
Study Start Date: April 2008
Study Completion Date: August 2008
Study Completion Date Type: Actual
Primary Completion Date: August 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): Single Group Assignment
Study Classification (Endpoint): Safety/Efficacy Study
Primary Outcomes:
  • Number of Subjects With an Immune Response to a Challenge Dose of Hepatitis B Vaccine no One month after the hepatitis B vaccine challenge dose
Secondary Outcomes:
  • Concentration of Anti-HBs Antibodies no One month after the hepatitis B vaccine challenge dose
  • Number of Subjects Reporting Unsolicited Adverse Events no During the 31-day follow-up period after the challenge dose of hepatitis B vaccine
  • Number of Subjects Reporting Serious Adverse Events no During the 31-day follow-up period after the challenge dose of hepatitis B vaccine
  • Number of Subjects With Anti-Hepatitis B surface antigen (anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values no One month after the hepatitis B vaccine challenge dose
Conditions:
  • Hepatitis B
Keywords:
  • Hepatitis
  • vaccine
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age:
Maximum Age:
Enrollment: 29
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: No locations currently recruiting for this study.