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Protocol Summary for 108988

Protocol Summary
Protocol Id: 108988
Secondary Ids:
  • N/A
Title: Administration of a challenge dose of hepatitis B vaccine in subjects who previously received Engerix™-B vaccine.
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:
  • Australia: Department of Health and Ageing Therapeutic Goods Administration
Collaborators:
  • N/A
Brief Summary: To evaluate the response to an additional dose (challenge dose) of hepatitis B vaccine, when given to subjects who had received primary vaccination of Engerix™-B vaccine approximately 72-78 months ago. This protocol posting deals with objectives & outcome measures of the challenge phase. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Detailed Description:
Record Verification Date: March 2011
Status: Completed
Why Study Stopped:
Study Start Date: November 2007
Study Completion Date: May 2008
Study Completion Date Type: Actual
Primary Completion Date: May 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 Participants With Immunological Response to Challenge Dose in Terms of Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration no 30 days post-challenge dose
Secondary Outcomes:
  • Number of Participants Reporting Serious Adverse Events (SAE) no During the 31-day follow-up period (Day 0-30) after the challenge dose
  • Number of Participants With Anti-HBs Antibody Concentrations Above the Cut-off Value no 30 days post-challenge dose
  • Concentration of Anti-HBs Antibodies no 30 days post-challenge dose
  • Number of Participants Reporting Solicited Local Symptoms no During the 4-day follow-up period (Day 0-3) after the challenge dose
  • Number of Participants Reporting Solicited General Symptoms no During the 4-day follow-up period (Day 0-3) after the challenge dose
  • Number of Participants Reporting Unsolicited Adverse Events (AE) no During the 31-day follow-up period (Day 0-30) after the challenge dose
Conditions:
  • Hepatitis B
Keywords:
  • Hepatitis B
  • Persistence
  • Challenge dose
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 17 Year
Maximum Age: 22 Year
Enrollment: 144
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