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Safety and Immunogenicity of GSK's Tdap Vaccine (Boostrix) in Adults Aged 19 to 64 Years

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00346073
First received: June 28, 2006
Last updated: October 4, 2012
Last verified: September 2012
History of Changes

June 28, 2006
October 4, 2012
July 2006
March 2007   (final data collection date for primary outcome measure)
Antibody concentrations to all vaccine antigens.
Same as current
Complete list of historical versions of study NCT00346073 on ClinicalTrials.gov Archive Site
Solicited & unsolicited symptoms, SAEs
Same as current
Not Provided
Not Provided
 
Safety and Immunogenicity of GSK's Tdap Vaccine (Boostrix) in Adults Aged 19 to 64 Years
A Study to Evaluate Immunogenicity and Safety of Boostrix Compared to Adacel When Administered as a Booster Vaccination in Adults Aged 19 to 64 Years of Age

GSK Biologicals' dTpa vaccine has recently been approved by the US Food and Drug Administration (FDA) for booster vaccination of adolescents aged 10 to 18 years. The ACIP has recently issued provisional recommendations for universal adult Tdap vaccination. The current study will provide pivotal data in support of extending the age range for Boostrix vaccine to include adults 19-64 years of age.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
  • Diphtheria
  • Pertussis
  • Tetanus
Biological: Tetanus, reduced diph toxoids, acellular pertussis vaccine
Not Provided
Blatter M, Friedland LR, Weston WM, Li P, Howe B. Immunogenicity and safety of a tetanus toxoid, reduced diphtheria toxoid and three-component acellular pertussis vaccine in adults 19-64 years of age. Vaccine. 2009 Jan 29;27(5):765-72. Epub 2008 Nov 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2337
March 2007
March 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • A healthy male or female, 19 to 64 years of age (not having reached the 65th birthday) at the time of study vaccination.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding administration of study vaccine, or planned use during the active phase of the study.
  • Chronic administration of immunosuppressants or within six months prior to administration of study vaccine.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of administration of study vaccine (with the exception of an influenza vaccine).
  • Administration of a diphtheria-tetanus (Td) booster within previous five years.
  • Administration of Tdap vaccine at any time prior to study entry. History of serious allergic reaction (e.g. anaphylaxis) following any other tetanus toxoid, diphtheria toxoid or pertussis-containing vaccine or any component of the study vaccines.
Both
19 Years to 64 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00346073
106316
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP