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

January 9, 2014 updated by: GlaxoSmithKline

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Oakland, California, United States, 94612
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Subjects enrolled in the Northern California Kaiser-Permanente Health Care Plan

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Boostrix cohort
Biological: Boostrix®
Single dose
Historical Td cohort
Biological: Td (Tetanus diphtheria) vaccine
Single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of medically-attended neurological events.
Time Frame: 30 days following vaccination with Boostrix.
30 days following vaccination with Boostrix.

Secondary Outcome Measures

Outcome Measure
Time Frame
Occurrence of medically-attended hematologic events
Time Frame: 30 days following vaccination with Boostrix
30 days following vaccination with Boostrix
Occurrence of allergic reactions.
Time Frame: 30 days following vaccination with Boostrix
30 days following vaccination with Boostrix
Occurrence of new onset chronic illnesses
Time Frame: 6-month period following vaccination with Boostrix
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

February 28, 2006

First Submitted That Met QC Criteria

February 28, 2006

First Posted (Estimate)

March 1, 2006

Study Record Updates

Last Update Posted (Estimate)

January 13, 2014

Last Update Submitted That Met QC Criteria

January 9, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 104154

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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