Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine Versus a Licensed Comparator in Children



Status:Completed
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any
Updated:8/2/2018
Start Date:October 1, 2008
End Date:June 1, 2009

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Immunogenicity and Safety of GSK Biologicals' Thimerosal-free TIV Flu Vaccine Versus a Licensed Comparator in Children

The purpose of this study is to evaluate the immunogenicity and the safety of GlaxoSmithKline
Biologicals' seasonal influenza vaccine, Fluarix, compared to Fluzone (a US-licensed vaccine)
in children, 6 to 35 months of age.


Inclusion Criteria:

- A male or female child aged 6 to 35 months at the time of the first 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.

- Written informed consent obtained from the subject's parent/guardian.

Exclusion Criteria:

- Use of any investigational or non-registered product (drug or 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 criterion.

- 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 enrolment.

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

- Receipt of an influenza vaccine outside of this study, during current (2008-09) flu
season.

- Administration of immunoglobulins and/or blood products within the 3 months preceding
the first dose of study vaccine or planned administration during the study period.
We found this trial at
62
sites
Saint Paul, Minnesota 55101
617
mi
from 43215
Saint Paul, MN
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Arkansas City, Kansas 67005
782
mi
from 43215
Arkansas City, KS
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Austin, Texas 78705
1064
mi
from 43215
Austin, TX
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Austintown, Ohio 44515
142
mi
from 43215
Austintown, OH
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Bardstown, Kentucky 40004
198
mi
from 43215
Bardstown, KY
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Benton, Arkansas 72019
644
mi
from 43215
Benton, AR
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Birmingham, Alabama 35249
493
mi
from 43215
Birmingham, AL
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Boone, North Carolina 28607
269
mi
from 43215
Boone, NC
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Bossier City, Louisiana 71111
786
mi
from 43215
Bossier City, LA
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Bountiful, Utah 84010
1512
mi
from 43215
Bountiful, UT
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Burke, Virginia 22015
317
mi
from 43215
Burke, VA
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Cary, North Carolina 27518
373
mi
from 43215
Cary, NC
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Charleston, South Carolina 29425
524
mi
from 43215
Charleston, SC
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Cincinnati, Ohio 45229
96
mi
from 43215
Cincinnati, OH
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Clarksville, Tennessee 37043
334
mi
from 43215
Clarksville, TN
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Cleveland, Ohio 44195
129
mi
from 43215
Cleveland, OH
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Conway, Arkansas 72034
615
mi
from 43215
Conway, AR
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Cortland, New York 14850
399
mi
from 43215
Cortland, NY
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Dayton, Ohio 45420
60
mi
from 43215
Dayton, OH
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DeKalb, Illinois 60115
328
mi
from 43215
DeKalb, IL
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Dothan, Alabama 36305
620
mi
from 43215
Dothan, AL
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Erie, Pennsylvania 16507
214
mi
from 43215
Erie, PA
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Fargo, North Dakota 58122
857
mi
from 43215
Fargo, ND
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Fayetteville, Arkansas 72703
659
mi
from 43215
Fayetteville, AR
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Fort Worth, Texas 76104
937
mi
from 43215
Fort Worth, TX
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Greenville, Pennsylvania 16125
190
mi
from 43215
Greenville, PA
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Gresham, Oregon 97030
2014
mi
from 43215
Gresham, OR
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Henderson, Nevada 89052
1755
mi
from 43215
Henderson, NV
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Houston, Texas 77030
995
mi
from 43215
Houston, TX
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Huntington Beach, California 92647
1968
mi
from 43215
Huntington Beach, CA
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Jackson, Tennessee 38305
436
mi
from 43215
Jackson, TN
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Jonesboro, Arkansas 72401
506
mi
from 43215
Jonesboro, AR
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Kingsport, Tennessee 37660
237
mi
from 43215
Kingsport, TN
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Latrobe, Pennsylvania 15650
194
mi
from 43215
Latrobe, PA
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Layton, Utah 84041
1515
mi
from 43215
Layton, UT
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Little Rock, Arkansas 72205
625
mi
from 43215
Little Rock, AR
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Long Beach, California 90813
1976
mi
from 43215
Long Beach, CA
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Longmont, Colorado 80501
1165
mi
from 43215
Longmont, CO
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Louisville, Kentucky 40202
188
mi
from 43215
Louisville, KY
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Metairie, Louisiana 70006
795
mi
from 43215
Metairie, LA
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Murray, Utah 84107
1514
mi
from 43215
Murray, UT
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Nampa, Idaho 83686
1734
mi
from 43215
Nampa, ID
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New Albany, Indiana 47150
189
mi
from 43215
New Albany, IN
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Newton, Kansas 67114
779
mi
from 43215
Newton, KS
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Norwich, Connecticut 06360
582
mi
from 43215
Norwich, CT
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Omaha, Nebraska 68131
683
mi
from 43215
Omaha, NE
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Paramount, California 90723
1972
mi
from 43215
Paramount, CA
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Pittsburgh, Pennsylvania 15213
165
mi
from 43215
Pittsburgh, PA
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?
mi
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Pokfulam,
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Provo, Utah 84604
1506
mi
from 43215
Provo, UT
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Raleigh, North Carolina 27614
366
mi
from 43215
Raleigh, NC
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Roy, Utah 84067
1517
mi
from 43215
Roy, UT
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Sacramento, California 95815
2040
mi
from 43215
Sacramento, CA
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Saint Louis, Missouri 63110
397
mi
from 43215
Saint Louis, MO
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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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South Jordan, Utah 84095
1517
mi
from 43215
South Jordan, UT
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Stevensville, Michigan 49127
230
mi
from 43215
Stevensville, MI
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Uniontown, Pennsylvania 15401
175
mi
from 43215
Uniontown, PA
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West Covina, California 91790
1955
mi
from 43215
West Covina, CA
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Wexford, Pennsylvania 15090
162
mi
from 43215
Wexford, PA
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Wichita, Kansas 67207
780
mi
from 43215
Wichita, KS
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