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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Diphtheria; Tetanus; Acellular Pertussis

Treatments: Biological: Td (Tetanus diphtheria) vaccine; Biological: Boostrix®

Study type: Observational

Funder types: Industry

Identifiers

NCT00297856

104154

Details and patient eligibility

About

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.

Full description

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

Enrollment: 10,000 patients

Sex: All

Ages: 10 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

10,000 participants in 2 patient groups

Boostrix cohort

Treatment:

Biological: Boostrix®

Historical Td cohort

Treatment:

Biological: Td (Tetanus diphtheria) vaccine