Safety and Immunogenicity of GSK's Tdap Vaccine (Boostrix) in Adults Aged 19 to 64 Years

Completed · Phase 3

Conditions studied: Acellular Pertussis, Diphtheria, Tetanus

In brief

GSK Biologicals' dTpa vaccine has recently been approved by the US Food and Drug Administration (FDA) for booster vaccination of adolescents aged 10 to 18 years. The ACIP has recently issued provisional recommendations for universal adult Tdap vaccination. The current study will provide pivotal data in support of extending the age range for Boostrix vaccine to include adults 19-64 years of age.

Key facts

Study ID

NCT00346073

Run by

GlaxoSmithKline

People needed

2337

Starts

2006-07-13

Expected to finish

2007-03-07

Last updated by the study team

2018-08-07

Who can join

Age: 19 and older, up to 64. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• A healthy male or female, 19 to 64 years of age (not having reached the 65th birthday) at the time of study vaccination.

You may not qualify if…

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding administration of study vaccine, or planned use during the active phase of the study.
• Chronic administration of immunosuppressants or within six months prior to administration of study vaccine.
• Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of administration of study vaccine (with the exception of an influenza vaccine).
• Administration of a diphtheria-tetanus (Td) booster within previous five years.
• Administration of Tdap vaccine at any time prior to study entry. History of serious allergic reaction (e.g. anaphylaxis) following any other tetanus toxoid, diphtheria toxoid or pertussis-containing vaccine or any component of the study vaccines.

Where it is running

• GSK Investigational Site — Huntsville, Alabama, United States
• GSK Investigational Site — Chandler, Arizona, United States
• GSK Investigational Site — Mesa, Arizona, United States
• GSK Investigational Site — Mesa, Arizona, United States
• GSK Investigational Site — Peoria, Arizona, United States
• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — Tempe, Arizona, United States
• GSK Investigational Site — Little Rock, Arkansas, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — Colorado Springs, Colorado, United States
• GSK Investigational Site — Pueblo, Colorado, United States
• GSK Investigational Site — Washington D.C., District of Columbia, United States
• GSK Investigational Site — Melbourne, Florida, United States
• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — Pembroke Pines, Florida, United States
• GSK Investigational Site — Tampa, Florida, United States
• GSK Investigational Site — Boise, Idaho, United States
• GSK Investigational Site — Peoria, Illinois, United States
• GSK Investigational Site — South Bend, Indiana, United States
• GSK Investigational Site — Bardstown, Kentucky, United States
• GSK Investigational Site — Richland, Michigan, United States
• GSK Investigational Site — Kansas City, Missouri, United States
• GSK Investigational Site — St Louis, Missouri, United States
• GSK Investigational Site — Alliance, Nebraska, United States

Full record on ClinicalTrials.gov

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