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

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: February 28, 2006
Last updated: January 9, 2014
Last verified: January 2014
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. ]

Secondary Outcome Measures:
  • Occurrence of medically-attended hematologic events [ Time Frame: 30 days following vaccination with Boostrix ]
  • Occurrence of allergic reactions. [ Time Frame: 30 days following vaccination with Boostrix ]
  • Occurrence of new onset chronic illnesses [ Time Frame: 6-month period following vaccination with Boostrix ]
  • Occurrence of neurological and hematological events and allergic reactions [ Time Frame: 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

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 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.

Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Subjects enrolled in the Northern California Kaiser-Permanente Health Care Plan

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 identifier: NCT00297856

United States, California
GSK Investigational Site
Oakland, California, United States, 94612
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline Identifier: NCT00297856     History of Changes
Other Study ID Numbers: 104154
Study First Received: February 28, 2006
Last Updated: January 9, 2014

Keywords provided by GlaxoSmithKline:

Additional relevant MeSH terms:
Whooping Cough
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Corynebacterium Infections
Actinomycetales Infections
Immunologic Factors
Physiological Effects of Drugs processed this record on September 21, 2017