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
Bardstown, Kentucky 40004
820
mi
from 02139
Bardstown, KY
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Antioch, California 94509
2653
mi
from 02139
Antioch, CA
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Austin, Texas 78705
1690
mi
from 02139
Austin, TX
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Cary, North Carolina 27518
615
mi
from 02139
Cary, NC
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Cleveland, Ohio 44195
543
mi
from 02139
Cleveland, OH
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Englewood, Colorado 80110
1764
mi
from 02139
Englewood, CO
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Fairfield, California 94533
2658
mi
from 02139
Fairfield, CA
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Fishkill, New York 12524
154
mi
from 02139
Fishkill, NY
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Fort Worth, Texas 76104
1574
mi
from 02139
Fort Worth, TX
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Fresno, California 93720
2582
mi
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Fresno, CA
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Hopewell Junction, New York 12533
?
mi
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Hopewell Junction, NY
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Lakewood, Colorado 80228
1772
mi
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Lakewood, CO
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Layton, Utah 84041
2089
mi
from 02139
Layton, UT
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Lexington, Kentucky 40504
768
mi
from 02139
Lexington, KY
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Metairie, Louisiana 70006
1356
mi
from 02139
Metairie, LA
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Omaha, Nebraska 68131
1277
mi
from 02139
Omaha, NE
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Pittsburgh, Pennsylvania 15213
477
mi
from 02139
Pittsburgh, PA
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Pleasanton, California 94588
2667
mi
from 02139
Pleasanton, CA
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Poughkeepsie, New York 12601
151
mi
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Poughkeepsie, NY
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Redwood City, California 94063
2687
mi
from 02139
Redwood City, CA
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Richmond, California 94801
2682
mi
from 02139
Richmond, CA
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Rochester, New York 14642
334
mi
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Rochester, NY
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Rolling Hills Estates, California 90274
2602
mi
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Rolling Hills Estates, CA
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Sacramento, California 95815
2619
mi
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Sacramento, CA
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Salt Lake City, Utah 84132
2088
mi
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Salt Lake City, UT
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San Angelo, Texas 76904
1774
mi
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San Angelo, TX
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San Francisco, California 94115
2691
mi
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San Francisco, CA
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Santa Clara, California 95051
2679
mi
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Santa Clara, CA
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Santa Rosa, California 95403
2688
mi
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Santa Rosa, CA
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South Jordan, Utah 84095
2097
mi
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South Jordan, UT
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Sylva, North Carolina 28779
810
mi
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Sylva, NC
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Tifton, Georgia 31794
1016
mi
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Tifton, GA
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Uniontown, Pennsylvania 15401
479
mi
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Uniontown, PA
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Vacaville, California 95688
2653
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Vacaville, CA
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Vallejo, California 94589
2672
mi
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Vallejo, CA
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Walnut Creek, California 94596
2667
mi
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Walnut Creek, CA
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West Jordan, Utah 84088
2098
mi
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West Jordan, UT
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Whitehouse Station, New Jersey 08889
224
mi
from 02139
Whitehouse Station, NJ
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