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
Lakewood, Colorado 80228
1171
mi
from 43215
Lakewood, CO
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Antioch, California 94509
2070
mi
from 43215
Antioch, CA
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Austin, Texas 78705
1064
mi
from 43215
Austin, TX
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Bardstown, Kentucky 40004
198
mi
from 43215
Bardstown, KY
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Cary, North Carolina 27518
373
mi
from 43215
Cary, NC
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Cleveland, Ohio 44195
129
mi
from 43215
Cleveland, OH
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Englewood, Colorado 80110
1163
mi
from 43215
Englewood, CO
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Fairfield, California 94533
2078
mi
from 43215
Fairfield, CA
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Fishkill, New York 12524
489
mi
from 43215
Fishkill, NY
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Fort Worth, Texas 76104
937
mi
from 43215
Fort Worth, TX
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Fresno, California 93720
1986
mi
from 43215
Fresno, CA
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Hopewell Junction, New York 12533
?
mi
from 43215
Hopewell Junction, NY
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Layton, Utah 84041
1515
mi
from 43215
Layton, UT
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Lexington, Kentucky 40504
156
mi
from 43215
Lexington, KY
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Metairie, Louisiana 70006
795
mi
from 43215
Metairie, LA
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Omaha, Nebraska 68131
683
mi
from 43215
Omaha, NE
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Pittsburgh, Pennsylvania 15213
165
mi
from 43215
Pittsburgh, PA
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Pleasanton, California 94588
2082
mi
from 43215
Pleasanton, CA
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Poughkeepsie, New York 12601
490
mi
from 43215
Poughkeepsie, NY
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Redwood City, California 94063
2101
mi
from 43215
Redwood City, CA
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Richmond, California 94801
2100
mi
from 43215
Richmond, CA
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Rochester, New York 14642
354
mi
from 43215
Rochester, NY
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Rolling Hills Estates, California 90274
1985
mi
from 43215
Rolling Hills Estates, CA
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Sacramento, California 95815
2040
mi
from 43215
Sacramento, CA
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Salt Lake City, Utah 84132
1511
mi
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Salt Lake City, UT
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San Angelo, Texas 76904
1136
mi
from 43215
San Angelo, TX
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San Francisco, California 94115
2108
mi
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San Francisco, CA
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Santa Clara, California 95051
2092
mi
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Santa Clara, CA
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Santa Rosa, California 95403
2111
mi
from 43215
Santa Rosa, CA
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South Jordan, Utah 84095
1517
mi
from 43215
South Jordan, UT
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Sylva, North Carolina 28779
317
mi
from 43215
Sylva, NC
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Tifton, Georgia 31794
588
mi
from 43215
Tifton, GA
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Uniontown, Pennsylvania 15401
175
mi
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Uniontown, PA
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Vacaville, California 95688
2073
mi
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Vacaville, CA
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Vallejo, California 94589
2092
mi
from 43215
Vallejo, CA
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Walnut Creek, California 94596
2084
mi
from 43215
Walnut Creek, CA
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West Jordan, Utah 84088
1519
mi
from 43215
West Jordan, UT
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Whitehouse Station, New Jersey 08889
437
mi
from 43215
Whitehouse Station, NJ
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