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

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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00297856

Enrollment

10000

Registered

2006-03-01

Start date

2006-03-31

Completion date

2006-12-31

Last updated

2014-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diphtheria, Tetanus, Acellular Pertussis

Keywords

Boostrix

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.

Interventions

BIOLOGICALBoostrix®

Single dose

BIOLOGICALTd (Tetanus diphtheria) vaccine

Single dose

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

10 Years to 18 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Occurrence of medically-attended hematologic events	30 days following vaccination with Boostrix
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	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026