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Protocol Summary for 263855/034

Protocol Summary
Protocol Id: 263855/034
Secondary Ids:
Title: Double-blind, randomized, phase III clinical trial to evaluate the immunogenicity and reactogenicity of three consecutive doses of dTpa, or of dTpa-IPV followed by two doses of Td vaccine , and compared to three consecutive doses of Td vaccine administered to healthy adults in a 0,1,6-month schedule
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:
  • Belgium: Agence Fédérale des Medicaments et des Produits de la Santé
  • Spain: Agencia Española del Medicamento y Productos Sanitarios
  • Netherlands: Minister van VWS Medische Technologie
Collaborators:
Brief Summary: This purpose of the study is to evaluate the immunogenicity and reactogenicity of Boostrix™ (when used in a primary schedule (0, 1, 6-month) or a single dose of Boostrix-IPV followed by two doses of Td vaccines (DitanrixTM Adult, TedivaxTM), as compared to three doses of licensed Td vaccines in adults.
Detailed Description:
Record Verification Date: February 2011
Status: Completed
Why Study Stopped:
Study Start Date: April 2003
Study Completion Date: September 2004
Study Completion Date Type: Actual
Primary Completion Date: September 2004
Primary Completion Date Type: Actual
Primary Purpose: prevention
Allocation: Randomized
Masking: Double Blind
Masked Subject: yes
Masked Caregiver: no
Masked Investigator: yes
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 the third dose (Month 7)
Secondary Outcomes:
  • Occurrence of solicited local and general symptoms Within 15 days (day 0 –14) after each vaccine dose.
  • Occurrence of unsolicited symptoms Within 31 days (day 0-30) after each vaccine dose.
  • Occurrence of large local swelling reported Within 15 days (day 0-14) after each vaccine dose
  • Use of concomitant medication taken Within 31 days (day 0-30) after each vaccine dose
  • Occurrence of serious adverse events Until 31 days (day 0-30) after the last vaccine dose.
  • Immunogenicity with respect to components of the study vaccines One month after each dose (Months 1, 2 and 7)
Conditions:
  • Diphtheria
  • Tetanus and Pertussis
Keywords:
  • DTPa
  • Td
  • IPV
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 40 Year
Maximum Age:
Enrollment: 460
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: No locations currently recruiting for this study.