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Protocol Summary for 110806

Protocol Summary
Protocol Id: 110806
Secondary Ids:
  • N/A
Title: Evaluation of GSK Bio’s dTpa booster vaccine in young adults 10 years after previous dTpa boosting.
Phase: phase 4
Acronym:
FDA Regulated Intervention?: No
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?: no
Study Type: Interventional
Oversight Authority:
  • Finland: National Agency of Medicines
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 prior clinical study. Only subjects who received booster vaccination in the previous clinical study are eligible for participation in this study.
Detailed Description: This Protocol Posting has been updated in order to comply with FDA AA, Sep 2007.
Record Verification Date:
Status: Completed
Why Study Stopped:
Study Start Date: January 2008
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): Efficacy Study
Primary Outcomes:
  • Anti-diphtheria antibody concentrations in Group A no One month after the booster dose
  • Anti-tetanus antibody concentrations in Group A no One month after the booster dose
Secondary Outcomes:
  • Anti-diphtheria antibody concentration no Prior to and one month after the booster dose
  • Anti-tetanus antibody concentrations no Prior to and one month after the booster dose
  • Anti-PT, anti-FHA and anti-PRN seropositivity no Prior to and one month after the booster dose
  • Anti-diphtheria, anti-tetanus, anti-PT, anti-FHA and anti-PRN antibody concentrations no Prior to and one month after the booster dose
  • Booster response to the PT, FHA and PRN antigens no Prior to and one month after the booster dose
  • Occurrence of solicited local and general symptoms no During the 4-day follow-up period
  • Occurrence of unsolicited symptoms no During the 31-day follow-up period
  • Occurrence of serious adverse events no During the 31-day follow-up period
Conditions:
  • Diphtheria
  • Tetanus
  • Pertussis
Keywords:
  • tetanus
  • pertussis
  • Tdap
  • dTpa vaccine
  • booster
  • Boostrix
  • diphtheria
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 20 Year
Maximum Age: 24 Year
Enrollment: 82
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