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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00297856
Recruitment Status : Completed
First Posted : March 1, 2006
Last Update Posted : January 13, 2014
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Diphtheria Tetanus Acellular Pertussis Biological: Boostrix® Biological: Td (Tetanus diphtheria) vaccine

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

Study Type : Observational
Actual Enrollment : 10000 participants
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)
Study Start Date : March 2006
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Group/Cohort Intervention/treatment
Boostrix cohort Biological: Boostrix®
Single dose

Historical Td cohort Biological: Td (Tetanus diphtheria) vaccine
Single dose

Primary Outcome Measures :
  1. Occurrence of medically-attended neurological events. [ Time Frame: 30 days following vaccination with Boostrix. ]

Secondary Outcome Measures :
  1. Occurrence of medically-attended hematologic events [ Time Frame: 30 days following vaccination with Boostrix ]
  2. Occurrence of allergic reactions. [ Time Frame: 30 days following vaccination with Boostrix ]
  3. Occurrence of new onset chronic illnesses [ Time Frame: 6-month period following vaccination with Boostrix ]
  4. Occurrence of neurological and hematological events and allergic reactions [ Time Frame: Within the second 30-day period following vaccination with Boostrix ]
  5. Occurrence of chronic illnesses in an historical control cohort of subjects vaccinated with Td vaccine

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00297856

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

Responsible Party: GlaxoSmithKline Identifier: NCT00297856     History of Changes
Other Study ID Numbers: 104154
First Posted: March 1, 2006    Key Record Dates
Last Update Posted: January 13, 2014
Last Verified: January 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