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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00297856
First received: February 28, 2006
Last updated: January 9, 2014
Last verified: January 2014
  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
Diphtheria
Tetanus
Acellular Pertussis
Biological: Boostrix®
Biological: Td (Tetanus diphtheria) vaccine

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: 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)

Resource links provided by NLM:


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: No ]

Secondary Outcome Measures:
  • Occurrence of medically-attended hematologic events [ Time Frame: 30 days following vaccination with Boostrix ] [ Designated as safety issue: No ]
  • Occurrence of allergic reactions. [ Time Frame: 30 days following vaccination with Boostrix ] [ Designated as safety issue: No ]
  • Occurrence of new onset chronic illnesses [ Time Frame: 6-month period following vaccination with Boostrix ] [ Designated as safety issue: No ]
  • 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: No ]
  • Occurrence of chronic illnesses in an historical control cohort of subjects vaccinated with Td vaccine [ Designated as safety issue: No ]

Enrollment: 10000
Study Start Date: March 2006
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Boostrix cohort
Not Applicable
Biological: Boostrix®
Single dose
Historical Td cohort
Not Applicable
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
Klein NP et al. (2010) 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. 29(1):613-617.

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00297856     History of Changes
Other Study ID Numbers: 104154
Study First Received: February 28, 2006
Last Updated: January 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Boostrix

Additional relevant MeSH terms:
Diphtheria
Whooping Cough
Tetanus
Tetany
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bordetella Infections
Gram-Negative Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Clostridium Infections
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Hypocalcemia
Calcium Metabolism Disorders
Metabolic Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014