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Protocol Summary for 711866/003

Protocol Summary
Protocol Id: 711866/003
Secondary Ids:
Title: Assess immunogenicity, reactogenicity of GSK Biologicals’-dTpa-IPV vaccine versus dTpa & IPV vaccines administered separately & compared with Aventis Pasteur MSD’s Td-IPV vaccine when administered to healthy adolescents & adults
Phase: phase 3
Acronym:
FDA Regulated Intervention?: Yes
Section 801 Clinical Trial?: Yes
Delayed Posting: No
IND/IDE Protocol?: no
Study Type: Interventional
Oversight Authority:
  • France: Afssaps - French Health Products Safety Agency
  • Germany: Paul-Ehrlich Institut
Collaborators:
Brief Summary: This study will assess the immunogenicity and reactogenicity of the candidate GSK Biologicals’ reduced antigen diphtheria and tetanus toxoids and acellular pertussis- inactivated poliovirus vaccine when administered to healthy subjects aged ≥ 15 years in Germany and ≥ 18 years in France compared to Boostrix™ and inactivated poliovirus vaccine administered separately, and with Revaxis®
Detailed Description:
Record Verification Date: January 2011
Status: Completed
Why Study Stopped:
Study Start Date: January 2002
Study Completion Date: April 2002
Study Completion Date Type: Actual
Primary Completion Date: April 2002
Primary Completion Date Type: Actual
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): Efficacy Study
Primary Outcomes:
  • Immunogenicity with respect to components of the study vaccines One month after vaccination (Month 1)
Secondary Outcomes:
  • Occurrence of unsolicited symptoms within 30 days (Day 0-29) after vaccination
  • Occurrence of serious adverse events Throughout the entire study (from Day 0 to Day 30)
  • Immunogenicity with respect to components of the study vaccines One month after vaccination (Month 1)
  • Immunogenicity with respect to some component of the study vaccines At Day 10 after vaccination
  • Occurrence of solicited local and general symptoms within 15 (Day 0-14) days after vaccination
Conditions:
  • Poliomyelitis
  • Diphtheria
  • Tetanus
  • Pertussis
Keywords:
  • Booster vaccination
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 15 Year
Maximum Age:
Enrollment: 806
Enrollment Type: Actual
Healthy Volunteers?: none
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: No locations currently recruiting for this study.