Post-Marketing Safety Study of GSK Biologicals' Boostrix® Vaccine. - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00297856

Purpose

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.

Condition	Intervention
Prophylaxis Against Diphtheria, Tetanus, and Pertussis	Biological: Td (Tetanus diphtheria) vaccine Biological: Boostrix®

MedlinePlus related topics: Diphtheria Tetanus Whooping Cough

Drug Information available for: Tetanus Vaccine

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
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)

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Occurrence of medically-attended neurological events. [ Time Frame: 30 days following vaccination with Boostrix. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Occurrence of medically-attended hematologic events [ Time Frame: 30 days following vaccination with Boostrix ] [ Designated as safety issue: Yes ]
Occurrence of allergic reactions. [ Time Frame: 30 days following vaccination with Boostrix ] [ Designated as safety issue: Yes ]
Occurrence of new onset chronic illnesses [ Time Frame: 6-month period following vaccination with Boostrix ] [ Designated as safety issue: Yes ]
Occurrence of neurological and hematological events and allergic reactions [ Time Frame: Within the second 30-day period following vaccination with Boostrix ] [ Designated as safety issue: Yes ]
Occurrence of chronic illnesses in an historical control cohort of subjects vaccinated with Td vaccine [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	25936
Study Start Date:	March 2006
Study Completion Date:	June 2007
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Boostrix cohort	Biological: Boostrix® Single dose
Historical Td cohort	Biological: Td (Tetanus diphtheria) vaccine Single dose

Detailed Description:

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

Eligibility

Ages Eligible for Study:	10 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00297856

Locations

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

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	104154
Study First Received:	February 28, 2006
Last Updated:	October 16, 2008
ClinicalTrials.gov Identifier:	NCT00297856
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Boostrix

Study placed in the following topic categories:

Bacterial Infections
Gram-Positive Bacterial Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Cough
Whooping Cough

Diphtheria
Clostridium Infections
Tetanus
Whooping cough
Gram-Negative Bacterial Infections

Additional relevant MeSH terms:

Bordetella Infections
Corynebacterium Infections
Infection
Actinomycetales Infections

ClinicalTrials.gov processed this record on January 15, 2009