Status:

COMPLETED

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

Lead Sponsor:

GlaxoSmithKline

Conditions:

Diphtheria

Tetanus

Eligibility:

All Genders

10-18 years

Brief 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 larg...

Detailed Description

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

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    March 1 2006

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    December 1 2006

    Estimated Enrollment :

    10000 Patients enrolled

    Trial Details

    Trial ID

    NCT00297856

    Start Date

    March 1 2006

    End Date

    December 1 2006

    Last Update

    January 13 2014

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    GSK Investigational Site

    Oakland, California, United States, 94612