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
Dayton, Ohio 45420
1900
mi
from 91732
Dayton, OH
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Arkansas City, Kansas 67005
1194
mi
from 91732
Arkansas City, KS
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Austin, Texas 78705
1211
mi
from 91732
Austin, TX
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Austintown, Ohio 44515
2079
mi
from 91732
Austintown, OH
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Bardstown, Kentucky 40004
1829
mi
from 91732
Bardstown, KY
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Benton, Arkansas 72019
1447
mi
from 91732
Benton, AR
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Birmingham, Alabama 35249
1777
mi
from 91732
Birmingham, AL
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Boone, North Carolina 28607
2046
mi
from 91732
Boone, NC
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Bossier City, Louisiana 71111
1403
mi
from 91732
Bossier City, LA
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Bountiful, Utah 84010
578
mi
from 91732
Bountiful, UT
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Burke, Virginia 22015
2268
mi
from 91732
Burke, VA
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Cary, North Carolina 27518
2211
mi
from 91732
Cary, NC
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Charleston, South Carolina 29425
2184
mi
from 91732
Charleston, SC
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Cincinnati, Ohio 45229
1880
mi
from 91732
Cincinnati, OH
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Clarksville, Tennessee 37043
1729
mi
from 91732
Clarksville, TN
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Cleveland, Ohio 44195
2036
mi
from 91732
Cleveland, OH
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Conway, Arkansas 72034
1452
mi
from 91732
Conway, AR
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Cortland, New York 14850
2317
mi
from 91732
Cortland, NY
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DeKalb, Illinois 60115
1673
mi
from 91732
DeKalb, IL
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Dothan, Alabama 36305
1894
mi
from 91732
Dothan, AL
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Erie, Pennsylvania 16507
2116
mi
from 91732
Erie, PA
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Fargo, North Dakota 58122
1400
mi
from 91732
Fargo, ND
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Fayetteville, Arkansas 72703
1354
mi
from 91732
Fayetteville, AR
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Fort Worth, Texas 76104
1195
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Fort Worth, TX
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Greenville, Pennsylvania 16125
2138
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from 91732
Greenville, PA
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Gresham, Oregon 97030
824
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Gresham, OR
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Henderson, Nevada 89052
213
mi
from 91732
Henderson, NV
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Houston, Texas 77030
1357
mi
from 91732
Houston, TX
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Huntington Beach, California 92647
24
mi
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Huntington Beach, CA
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Jackson, Tennessee 38305
1653
mi
from 91732
Jackson, TN
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Jonesboro, Arkansas 72401
1546
mi
from 91732
Jonesboro, AR
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Kingsport, Tennessee 37660
1994
mi
from 91732
Kingsport, TN
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Latrobe, Pennsylvania 15650
2151
mi
from 91732
Latrobe, PA
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Layton, Utah 84041
584
mi
from 91732
Layton, UT
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Little Rock, Arkansas 72205
1459
mi
from 91732
Little Rock, AR
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Long Beach, California 90813
22
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Long Beach, CA
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Longmont, Colorado 80501
824
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Longmont, CO
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Louisville, Kentucky 40202
1813
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Louisville, KY
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Metairie, Louisiana 70006
1647
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Metairie, LA
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Murray, Utah 84107
565
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Murray, UT
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Nampa, Idaho 83686
658
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Nampa, ID
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New Albany, Indiana 47150
1809
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New Albany, IN
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Newton, Kansas 67114
1183
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Newton, KS
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Norwich, Connecticut 06360
2529
mi
from 91732
Norwich, CT
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Omaha, Nebraska 68131
1299
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Omaha, NE
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Paramount, California 90723
15
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Paramount, CA
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Pittsburgh, Pennsylvania 15213
2121
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Pittsburgh, PA
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?
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Pokfulam,
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Provo, Utah 84604
550
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Provo, UT
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Raleigh, North Carolina 27614
2217
mi
from 91732
Raleigh, NC
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Roy, Utah 84067
588
mi
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Roy, UT
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Sacramento, California 95815
365
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Sacramento, CA
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Saint Louis, Missouri 63110
1570
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Saint Louis, MO
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Saint Paul, Minnesota 55101
1517
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Saint Paul, MN
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San Angelo, Texas 76904
1035
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San Angelo, TX
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San Francisco, California 94115
356
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San Francisco, CA
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South Jordan, Utah 84095
558
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South Jordan, UT
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Stevensville, Michigan 49127
1787
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from 91732
Stevensville, MI
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Uniontown, Pennsylvania 15401
2134
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Uniontown, PA
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West Covina, California 91790
4
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West Covina, CA
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Wexford, Pennsylvania 15090
2116
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Wexford, PA
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Wichita, Kansas 67207
1186
mi
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Wichita, KS
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