Study Comparing the Immune Response and Safety of Fluarix and Fluzone Influenza Vaccines in Children



Status:Completed
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any - 17
Updated:6/10/2018
Start Date:November 2, 2006
End Date:October 19, 2007

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A Phase III, Single-blind, Randomized Study to Evaluate the Immunogenicity and Safety of Fluarix® (GSK Biologicals') Compared With Fluzone® (Aventis Pasteur/Sanofi) Administered Intramuscularly in Children (6 Months and Older)

The purpose of this study is to compare two influenza vaccines (Fluzone and Fluarix) in terms
of the immune response elicited and safety with a six month follow-up after first
vaccination. The Protocol Posting has been updated in order to comply with the FDA Amendment
Act, Sep 2007.


Inclusion Criteria:

- A male or female child age 6 months to < 18 years at the time of the vaccination;
children who may or may not have had previous administration of influenza vaccine in a
previous season are acceptable.

- Subjects having a parent/guardian who the investigator believes can and will comply
with the requirements of the protocol should be enrolled in the study.

- Written informed consent obtained from the subject's parent/guardian; assent obtained
in subjects > 10 years.

- Female subjects of childbearing potential must agree to take a pregnancy test.

Exclusion Criteria:

- Use of any investigational or non-registered product (drug or vaccine, other than the
study vaccine) within 30 days preceding the administration of the study vaccine, or
planned use during the study period. Routine, registered childhood vaccinations are
not an exclusion.

- History of hypersensitivity to any vaccine.

- History of allergy or reactions likely to be exacerbated by any component of the
vaccine.

- Acute disease at the time of enrollment.

- History of Guillain Barré syndrome within 6 weeks of receipt of prior inactivated
influenza virus vaccine.

- Pregnant or lactating female.

- Receipt of an influenza vaccine outside of this study, during current (2006-07) flu
season.
We found this trial at
38
sites
Cleveland, Ohio 44195
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Antioch, California 94509
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Austin, Texas 78705
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Austin, TX
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Bardstown, Kentucky 40004
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Bardstown, KY
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Cary, North Carolina 27518
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Cary, NC
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Englewood, Colorado 80110
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Englewood, CO
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Fairfield, California 94533
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Fairfield, CA
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Fishkill, New York 12524
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Fishkill, NY
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Fort Worth, Texas 76104
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Fort Worth, TX
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Fresno, California 93720
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Fresno, CA
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Hopewell Junction, New York 12533
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Hopewell Junction, NY
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Lakewood, Colorado 80228
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Layton, Utah 84041
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Layton, UT
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Lexington, Kentucky 40504
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Lexington, KY
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Metairie, Louisiana 70006
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Metairie, LA
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Omaha, Nebraska 68131
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Omaha, NE
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Pittsburgh, Pennsylvania 15213
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Pleasanton, California 94588
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Poughkeepsie, New York 12601
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Redwood City, California 94063
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Richmond, California 94801
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Richmond, CA
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Rochester, New York 14642
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Rochester, NY
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Rolling Hills Estates, California 90274
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Rolling Hills Estates, CA
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Sacramento, California 95815
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Salt Lake City, Utah 84132
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San Angelo, Texas 76904
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San Francisco, California 94115
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Santa Clara, California 95051
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Santa Rosa, California 95403
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South Jordan, Utah 84095
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Sylva, North Carolina 28779
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Tifton, Georgia 31794
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Tifton, GA
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Uniontown, Pennsylvania 15401
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Vacaville, California 95688
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Vallejo, California 94589
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Walnut Creek, California 94596
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West Jordan, Utah 84088
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Whitehouse Station, New Jersey 08889
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Whitehouse Station, NJ
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