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

Completed

• Conditions: Diphtheria; Tetanus; Acellular Pertussis
• Interventions: Biological: Boostrix®; Biological: Td (Tetanus diphtheria) vaccine

• Registration Number: NCT00297856
• Lead Sponsor: GlaxoSmithKline

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 large population cohort. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed Description

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2006-02-28
• Study First Submitted QC: 2006-02-28
• Study Start: 2006-03
• Study First Posted: 2006-03-01
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-09
• Last Update Posted: 2014-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10000

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Boostrix cohort	Boostrix®	-
Historical Td cohort	Td (Tetanus diphtheria) vaccine	-

Primary Outcome Measures

Name	Time	Method
Occurrence of medically-attended neurological events.	30 days following vaccination with Boostrix.

Secondary Outcome Measures

Name	Time	Method
Occurrence of allergic reactions.	30 days following vaccination with Boostrix
Occurrence of new onset chronic illnesses	6-month period following vaccination with Boostrix
Occurrence of neurological and hematological events and allergic reactions	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
Occurrence of medically-attended hematologic events	30 days following vaccination with Boostrix

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Oakland, California, United States