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
Newton, Kansas 67114
33
mi
from
Newton, KS
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Arkansas City, Kansas 67005
64
mi
from
Arkansas City, KS
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Austin, Texas 78705
515
mi
from
Austin, TX
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Austintown, Ohio 44515
937
mi
from
Austintown, OH
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Bardstown, Kentucky 40004
674
mi
from
Bardstown, KY
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Benton, Arkansas 72019
365
mi
from
Benton, AR
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Birmingham, Alabama 35249
676
mi
from
Birmingham, AL
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Boone, North Carolina 28607
896
mi
from
Boone, NC
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Bossier City, Louisiana 71111
429
mi
from
Bossier City, LA
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Bountiful, Utah 84010
781
mi
from
Bountiful, UT
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Burke, Virginia 22015
1114
mi
from
Burke, VA
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Cary, North Carolina 27518
1061
mi
from
Cary, NC
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Charleston, South Carolina 29425
1063
mi
from
Charleston, SC
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Cincinnati, Ohio 45229
727
mi
from
Cincinnati, OH
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Clarksville, Tennessee 37043
582
mi
from
Clarksville, TN
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Cleveland, Ohio 44195
898
mi
from
Cleveland, OH
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Conway, Arkansas 72034
351
mi
from
Conway, AR
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Cortland, New York 14850
1186
mi
from
Cortland, NY
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Dayton, Ohio 45420
749
mi
from
Dayton, OH
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DeKalb, Illinois 60115
560
mi
from
DeKalb, IL
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Dothan, Alabama 36305
833
mi
from
Dothan, AL
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Erie, Pennsylvania 16507
984
mi
from
Erie, PA
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Fargo, North Dakota 58122
635
mi
from
Fargo, ND
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Fayetteville, Arkansas 72703
234
mi
from
Fayetteville, AR
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Fort Worth, Texas 76104
348
mi
from
Fort Worth, TX
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Greenville, Pennsylvania 16125
994
mi
from
Greenville, PA
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Gresham, Oregon 97030
1371
mi
from
Gresham, OR
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Henderson, Nevada 89052
957
mi
from
Henderson, NV
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Houston, Texas 77030
572
mi
from
Houston, TX
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Huntington Beach, California 92647
1162
mi
from
Huntington Beach, CA
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Jackson, Tennessee 38305
520
mi
from
Jackson, TN
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Jonesboro, Arkansas 72401
415
mi
from
Jonesboro, AR
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Kingsport, Tennessee 37660
843
mi
from
Kingsport, TN
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Latrobe, Pennsylvania 15650
1003
mi
from
Latrobe, PA
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Layton, Utah 84041
788
mi
from
Layton, UT
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Little Rock, Arkansas 72205
368
mi
from
Little Rock, AR
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Long Beach, California 90813
1172
mi
from
Long Beach, CA
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Longmont, Colorado 80501
425
mi
from
Longmont, CO
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Louisville, Kentucky 40202
657
mi
from
Louisville, KY
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Metairie, Louisiana 70006
688
mi
from
Metairie, LA
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Murray, Utah 84107
778
mi
from
Murray, UT
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Nampa, Idaho 83686
1057
mi
from
Nampa, ID
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New Albany, Indiana 47150
653
mi
from
New Albany, IN
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Norwich, Connecticut 06360
1389
mi
from
Norwich, CT
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Omaha, Nebraska 68131
262
mi
from
Omaha, NE
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Paramount, California 90723
1167
mi
from
Paramount, CA
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Pittsburgh, Pennsylvania 15213
974
mi
from
Pittsburgh, PA
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?
mi
from
Pokfulam,
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Provo, Utah 84604
761
mi
from
Provo, UT
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Raleigh, North Carolina 27614
1066
mi
from
Raleigh, NC
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Roy, Utah 84067
792
mi
from
Roy, UT
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Sacramento, California 95815
1280
mi
from
Sacramento, CA
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Saint Louis, Missouri 63110
415
mi
from
Saint Louis, MO
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Saint Paul, Minnesota 55101
554
mi
from
Saint Paul, MN
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San Angelo, Texas 76904
459
mi
from
San Angelo, TX
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San Francisco, California 94115
1340
mi
from
San Francisco, CA
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South Jordan, Utah 84095
779
mi
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South Jordan, UT
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Stevensville, Michigan 49127
666
mi
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Stevensville, MI
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Uniontown, Pennsylvania 15401
984
mi
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Uniontown, PA
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West Covina, California 91790
1151
mi
from
West Covina, CA
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Wexford, Pennsylvania 15090
970
mi
from
Wexford, PA
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Wichita, Kansas 67207
32
mi
from
Wichita, KS
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