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

NCT ID: NCT00297856

Last Updated: 2014-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-03-31

Study Completion Date

2006-12-31

Brief Summary

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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.

Detailed Description

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

Conditions

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Diphtheria Tetanus Acellular Pertussis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Boostrix cohort

Boostrix®

Intervention Type BIOLOGICAL

Single dose

Historical Td cohort

Td (Tetanus diphtheria) vaccine

Intervention Type BIOLOGICAL

Single dose

Interventions

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Boostrix®

Single dose

Intervention Type BIOLOGICAL

Td (Tetanus diphtheria) vaccine

Single dose

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Oakland, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 20190673 (View on PubMed)

Other Identifiers

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104154

Identifier Type: -

Identifier Source: org_study_id

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