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Home > Protocol Summaries: Compounds > Combined Reduced Antigen Content Diphtheria, Tetanus, Acellular Pertussis Vaccine > Protocol Summary for 108638

Protocol Summary for 108638

Protocol Summary
Protocol Id: 108638
Secondary Ids:
Title: Immunogenicity and safety study of GlaxoSmithKline (GSK) Biologicals’ Boostrix (dTpa) vaccine and the Chinese DT vaccine, when administered as booster vaccination in healthy children aged 6-8 years
Phase: phase 3
Acronym:
FDA Regulated Intervention?:
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?: no
Study Type: Interventional
Oversight Authority:
  • China: State Food and Drug Administration
Collaborators:
Brief Summary:
Detailed Description:
Record Verification Date: October 2012
Status: Completed
Why Study Stopped:
Study Start Date: March 2007
Study Completion Date:
Study Completion Date Type:
Primary Completion Date:
Primary Completion Date Type:
Primary Purpose: prevention
Allocation: Randomized
Masking: Open Label
Masked Subject: no
Masked Caregiver: no
Masked Investigator: no
Masked Assessor: no
Study Design (Assignment): Parallel Assignment
Study Classification (Endpoint): Safety/Efficacy Study
Primary Outcomes:
  • Anti-diphtheria, anti-tetanus, anti-PT, anti-PRN & anti-FHA antibody concentration.
Secondary Outcomes:
  • Solicited symptoms (Day 0-3), unsolicited AEs (Day 0-30) & SAEs
Conditions:
  • Diphtheria
  • Tetanus
  • Pertussis
Keywords:
  • Chinese DT vaccin
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 6 Year
Maximum Age: 8 Year
Enrollment: 660
Enrollment Type:
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