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



Status:Completed
Conditions:Infectious Disease, Infectious Disease, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:19 - 64
Updated:8/9/2018
Start Date:July 13, 2006
End Date:March 7, 2007

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A Study to Evaluate Immunogenicity and Safety of Boostrix Compared to Adacel When Administered as a Booster Vaccination in Adults Aged 19 to 64 Years of Age

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.


Inclusion Criteria:

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

Exclusion Criteria:

- 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.
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Winston-Salem, North Carolina 27103
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Albuquerque, New Mexico 87109
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Alliance, Nebraska 69301
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Bardstown, Kentucky 40004
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Bismarck, North Dakota 58501
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Boise, Idaho 83712
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Bristol, Tennessee 37620
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Chandler, Arizona 85224
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Colorado Springs, Colorado 80910
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Grove City, Pennsylvania 16127
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Hickory, North Carolina 28601
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Houston, Texas 77030
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Huntsville, Alabama 35801
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Kansas City, Missouri 64128
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Knoxville, Tennessee 37916
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Las Vegas, Nevada 89102
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Little Rock, Arkansas 72205
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Melbourne, Florida 32935
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Mesa, Arizona 85206
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Miami, Florida 33136
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Norfolk, Virginia 23502
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North Platte, Nebraska 69101
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Oklahoma City, Oklahoma 73112
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Pembroke Pines, Florida 33028
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Peoria, Arizona 85381
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Peoria, Illinois 61636
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Phoenix, Arizona 85012
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Pittsburgh, Pennsylvania 15213
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Pueblo, Colorado 81001
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Raleigh, North Carolina 27614
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Richland, Michigan 49083
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Saint Louis, Missouri 63110
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Salt Lake City, Utah 84132
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San Diego, California 92111
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South Bend, Indiana 46601
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Tampa, Florida 33612
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Tempe, Arizona 85284
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Washington, District of Columbia 20007
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West Jordan, Utah 84088
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