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Combined Tdap (Tetanus, Diphtheria, acellular Pertussis) Vaccine Used As A Booster Compared To Licensed Td (Tetanus and Diphtheria) Vaccine - Article


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Tetanus

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Clinical Trial: Combined Tdap (Tetanus, Diphtheria, acellular Pertussis) Vaccine Used As A Booster Compared To Licensed Td (Tetanus and Diphtheria) Vaccine

This study has been completed.

Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline

Purpose

This study will evaluate the safety and immune response to GlaxoSmithKline Tdap vaccine compared to licensed Td vaccine when used as a booster in healthy adolescents (10-18 years of age).

Condition Treatment or Intervention Phase
Diphtheria
Tetanus
Pertussis
 Vaccine: Combined diphtheria, tetanus, acellular pertussis vaccine
Phase III

MedlinePlus related topics:  Bacterial Infections;   Bronchitis;   Diphtheria;   Respiratory Diseases;   Tetanus

Study Type: Interventional
Study Design: Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Eligibility

Ages Eligible for Study:  10 Years   -   18 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

  • Healthy adolescents with history of completed routine vaccination against diphtheria, tetanus, and pertussis (DTP).

Exclusion Criteria:

  • Use of any other investigational drug or vaccine 30 days preceding study vaccination.
  • Chronic administration of immunosuppressants.
  • Administration of pre-school DTP vaccine within previous 5 years.
  • Administration of Td booster within previous 10 years.

Location Information


Arizona
      Jonesboro,  Arizona,  72401,  United States

      Mesa,  Arizona,  85201,  United States

      Tempe,  Arizona,  85282,  United States

Arkansas
      Little Rock,  Arkansas,  72202,  United States

California
      Rolling Hills Estates,  California,  90274,  United States

      Torrance,  California,  90502,  United States

      Fountain Valley,  California,  92708,  United States

      Fullerton,  California,  92835,  United States

      Yorba Linda,  California,  92886,  United States

Colorado
      Centennial,  Colorado,  80112,  United States

      Boulder,  Colorado,  80304,  United States

      Golden,  Colorado,  80401,  United States

Connecticut
      Norwich,  Connecticut,  06360,  United States

      Middletown,  Connecticut,  06457,  United States

Florida
      Jacksonville,  Florida,  32209,  United States

      Jacksonville,  Florida,  32209,  United States

Illinois
      Chicago,  Illinois,  60614,  United States

Kentucky
      Bardstown,  Kentucky,  40004,  United States

Massachusetts
      Milford,  Massachusetts,  01757,  United States

      Woburn,  Massachusetts,  01801,  United States

      Boston,  Massachusetts,  02130,  United States

Nebraska
      Omaha,  Nebraska,  68131,  United States

New Jersey
      Whitehouse Station,  New Jersey,  08889,  United States

New York
      Stony Brook,  New York,  11794-0001,  United States

      Rochester,  New York,  14620,  United States

North Carolina
      Raleigh,  North Carolina,  27609,  United States

      Durham,  North Carolina,  27704,  United States

      Sylva,  North Carolina,  28779,  United States

Ohio
      Columbus,  Ohio,  43214,  United States

      Cleveland,  Ohio,  44109,  United States

      University Heights,  Ohio,  44118,  United States

      Akron,  Ohio,  44308-1062,  United States

Pennsylvania
      Pittsburgh,  Pennsylvania,  15241,  United States

      Sellersville,  Pennsylvania,  18960,  United States

Tennessee
      Johnson City,  Tennessee,  37615,  United States

Texas
      Temple,  Texas,  76508,  United States

      Houston,  Texas,  77030,  United States

      Bryan,  Texas,  77802,  United States

      Austin,  Texas,  78758,  United States

Utah
      West Jordan,  Utah,  84084,  United States

      Salt Lake City,  Utah,  84109,  United States

Virginia
      Norfolk,  Virginia,  23510,  United States

More Information

Study ID Numbers:  776423/001
Record last reviewed:  April 2005
Last Updated:  April 26, 2005
Record first received:  April 26, 2005
ClinicalTrials.gov Identifier:  NCT00109330
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-05-03


Source: ClinicalTrials.gov
Cache Date: May 4, 2005

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December 6, 2009



Page Updated: October 15, 2009
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