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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00297856
First received: February 28, 2006
Last updated: January 9, 2014
Last verified: January 2014

February 28, 2006
January 9, 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. ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • Occurrence of allergic reactions. [ Time Frame: 30 days following vaccination with Boostrix ] [ Designated as safety issue: No ]
  • Occurrence of new onset chronic illnesses [ Time Frame: 6-month period following vaccination with Boostrix ] [ Designated as safety issue: No ]
  • Occurrence of neurological and hematological events and allergic reactions [ Time Frame: Within the second 30-day period following vaccination with Boostrix ] [ Designated as safety issue: No ]
  • Occurrence of chronic illnesses in an historical control cohort of subjects vaccinated with Td vaccine [ Designated as safety issue: No ]
Not Provided
Not Provided
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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
Not Provided
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
    Not Applicable
    Intervention: Biological: Boostrix®
  • Historical Td cohort
    Not Applicable
    Intervention: Biological: Td (Tetanus diphtheria) vaccine
Klein NP et al. (2010) 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. 29(1):613-617.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10000
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
Both
10 Years to 18 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00297856
104154
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
January 2014

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