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Protocol Summary for 110804

Protocol Summary
Protocol Id: 110804
Secondary Ids:
  • N/A
Title: Evaluation of GSK Bio's dTpa booster vaccine in adults, given 10 years after previous dTpa boosting.
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: The purpose of this study is to assess the efficacy and safety of repeating dTpa booster in adults 10 years after previous booster vaccination with dTpa in a previous clinical study. Only subjects who received the booster vaccination in a previous clinical study are eligible for participation in this study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007. No new recruitment will be performed in this booster phase (see inclusion criteria)
Detailed Description:
Record Verification Date:
Status: Completed
Why Study Stopped:
Study Start Date: November 2007
Study Completion Date: April 2008
Study Completion Date Type: Actual
Primary Completion Date: April 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): Safety/Efficacy Study
Primary Outcomes:
  • In Group A:- Anti-diphtheria antibody concentrations no One month after the booster dose
  • In Group A:- Anti-tetanus antibody concentrations no One month after the booster dose
Secondary Outcomes:
  • Booster response to pertussis antigens no One month after booster vaccination
  • Occurrence of solicited local and general symptoms yes During the 4-day follow-up period after booster vaccination
  • Occurrence of unsolicited symptoms yes During the 31-day follow-up period after booster vaccination
  • Occurrence of serious adverse events yes Following booster vaccination
  • In all subjects:- Anti-diphtheria antibody concentration no Prior to booster vaccination
  • Anti-tetanus antibody concentrations no Prior to booster vaccination
  • Anti-pertussis antibody concentrations no Prior to and 1 month after booster vaccination
Conditions:
  • Diphtheria
  • Tetanus
  • Pertussis
Keywords:
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 28 Year
Maximum Age:
Enrollment: 205
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