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

Tetanus Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00297856
• Other study ID #: 104154
• Status: Completed
• Phase: N/A
• First received: February 28, 2006
• Last updated: January 9, 2014
• Start date: March 2006
• Est. completion date: December 2006

Study information

• Verified date: January 2014
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10000
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Years to 18 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acellular Pertussis
• Diphtheria
• Tetanus
• Whooping Cough

Intervention

Biological:
• Boostrix®
Single dose
• Td (Tetanus diphtheria) vaccine
Single dose

Locations

Country	Name	City	State
United States	GSK Investigational Site	Oakland	California

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (1)

Klein NP, Hansen J, Lewis E, Lyon L, Nguyen B, Black S, Weston WM, Wu S, Li P, Howe B, Friedland LR. Post-marketing safety evaluation of a tetanus toxoid, reduced diphtheria toxoid and 3-component acellular pertussis vaccine administered to a cohort of adolescents in a United States health maintenance organization. Pediatr Infect Dis J. 2010 Jul;29(7):613-7. doi: 10.1097/INF.0b013e3181d581f9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of medically-attended neurological events.		30 days following vaccination with Boostrix.	No
Secondary	Occurrence of medically-attended hematologic events		30 days following vaccination with Boostrix	No
Secondary	Occurrence of allergic reactions.		30 days following vaccination with Boostrix	No
Secondary	Occurrence of new onset chronic illnesses		6-month period following vaccination with Boostrix	No
Secondary	Occurrence of neurological and hematological events and allergic reactions		Within the second 30-day period following vaccination with Boostrix	No
Secondary	Occurrence of chronic illnesses in an historical control cohort of subjects vaccinated with Td vaccine			No