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Post-marketing Safety Study of GSK Biologicals' Boostrix® Vaccine

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ClinicalTrials.gov Identifier: NCT00297856
Recruitment Status : Completed
First Posted : March 1, 2006
Last Update Posted : January 13, 2014
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

February 28, 2006
March 1, 2006
January 13, 2014
March 2006
December 2006   (Final data collection date for primary outcome measure)
Occurrence of medically-attended neurological events. [ Time Frame: 30 days following vaccination with Boostrix. ]
Not Provided
Complete list of historical versions of study NCT00297856 on ClinicalTrials.gov Archive Site
  • Occurrence of medically-attended hematologic events [ Time Frame: 30 days following vaccination with Boostrix ]
  • Occurrence of allergic reactions. [ Time Frame: 30 days following vaccination with Boostrix ]
  • Occurrence of new onset chronic illnesses [ Time Frame: 6-month period following vaccination with Boostrix ]
  • Occurrence of neurological and hematological events and allergic reactions [ Time Frame: Within the second 30-day period following vaccination with Boostrix ]
  • Occurrence of chronic illnesses in an historical control cohort of subjects vaccinated with Td vaccine
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Post-marketing Safety Study of GSK Biologicals' Boostrix® Vaccine
Open, Prospective Study of the Safety of GSK Biologicals' Boostrix® (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed) Administered to a Cohort of Adolescents in a US Health Maintenance Organization (HMO)
Pre-licensure studies of GSK Biologicals' Boostrix® have shown it to be generally safe and well-tolerated. This post-licensure study is designed to evaluate relatively uncommon/rare outcomes in a large population cohort. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Data collection through utilization of automated databases at the study site. The collaborator is Kaiser Permanente Vaccine Study Center.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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Probability Sample
Subjects enrolled in the Northern California Kaiser-Permanente Health Care Plan
  • Diphtheria
  • Tetanus
  • Acellular Pertussis
  • Biological: Boostrix®
    Single dose
  • Biological: Td (Tetanus diphtheria) vaccine
    Single dose
  • Boostrix cohort
    Intervention: Biological: Boostrix®
  • Historical Td cohort
    Intervention: Biological: Td (Tetanus diphtheria) vaccine
Klein NP, Hansen J, Lewis E, Lyon L, Nguyen B, Black S, Weston WM, Wu S, Li P, Howe B, Friedland LR. Post-marketing safety evaluation of a tetanus toxoid, reduced diphtheria toxoid and 3-component acellular pertussis vaccine administered to a cohort of adolescents in a United States health maintenance organization. Pediatr Infect Dis J. 2010 Jul;29(7):613-7. doi: 10.1097/INF.0b013e3181d581f9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10000
Same as current
December 2006
December 2006   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects between the age of 10 and 18 years (inclusive) who received a dose of Boostrix and who have safety follow-up information available
Sexes Eligible for Study: All
10 Years to 18 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00297856
104154
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GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
January 2014