Quick Search

 

 


 

 

Protocol Summary for 108984

Protocol Summary
Protocol Id: 108984
Secondary Ids:
  • N/A
Title: To Evaluate Immune Response to a Hepatitis B Vaccine (Engerix™-B ) Challenge Dose in Healthy Subjects Who Received GSK Biologicals' Hepatitis B Vaccine (Engerix™-B ) Approximately 20 Years Ago as Primary Vaccination at 0, 1, 2 and 12 Months.
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: not applicable
Collaborators:
  • N/A
Brief Summary:
Detailed Description:
Record Verification Date:
Status: Completed
Why Study Stopped:
Study Start Date: April 2007
Study Completion Date: January 2008
Study Completion Date Type: Actual
Primary Completion Date: January 2008
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): Single Group Assignment
Study Classification (Endpoint): Safety/Efficacy Study
Primary Outcomes:
  • Number of Participants With Anti-Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Specific Cut-Off Values One month after the hepatitis B vaccine challenge dose
Secondary Outcomes:
  • Occurrence, Intensity and Relationship to Vaccination of Unsolicited Adverse Events (AEs) During the 31-day follow-up period after the challenge dose of hepatitis B vaccine.
  • Number of Participants Reporting Any Serious Adverse Events (SAEs). Up to 1 month after the challenge dose.
Conditions:
  • Hepatitis B Vaccine
  • Hepatitis B
Keywords:
  • Hepatitis B vaccine
  • Challenge dose
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 20 Year
Maximum Age: 21 Year
Enrollment: 76
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