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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00297856
Other study ID # 104154
Secondary ID
Status Completed
Phase N/A
First received February 28, 2006
Last updated January 9, 2014
Start date March 2006
Est. completion date December 2006

Study information

Verified date January 2014
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial Summary

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.


Description:

Data collection through utilization of automated databases at the study site. The collaborator is Kaiser Permanente Vaccine Study Center.


Recruitment information / eligibility

Status Completed
Enrollment 10000
Est. completion date December 2006
Est. primary completion date December 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 10 Years to 18 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Biological:
Boostrix®
Single dose
Td (Tetanus diphtheria) vaccine
Single dose

Locations

Country Name City State
United States GSK Investigational Site Oakland California

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Occurrence of medically-attended neurological events. 30 days following vaccination with Boostrix. No
Secondary Occurrence of medically-attended hematologic events 30 days following vaccination with Boostrix No
Secondary Occurrence of allergic reactions. 30 days following vaccination with Boostrix No
Secondary Occurrence of new onset chronic illnesses 6-month period following vaccination with Boostrix No
Secondary Occurrence of neurological and hematological events and allergic reactions Within the second 30-day period following vaccination with Boostrix No
Secondary Occurrence of chronic illnesses in an historical control cohort of subjects vaccinated with Td vaccine No
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