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
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Paramount, California 90723
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Arkansas City, Kansas 67005
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Austin, Texas 78705
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Austintown, Ohio 44515
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Bardstown, Kentucky 40004
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Benton, Arkansas 72019
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Birmingham, Alabama 35249
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Boone, North Carolina 28607
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Bossier City, Louisiana 71111
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Bountiful, Utah 84010
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Burke, Virginia 22015
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Cary, North Carolina 27518
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Charleston, South Carolina 29425
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Cincinnati, Ohio 45229
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Clarksville, Tennessee 37043
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Cleveland, Ohio 44195
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Conway, Arkansas 72034
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Cortland, New York 14850
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Dayton, Ohio 45420
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DeKalb, Illinois 60115
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Dothan, Alabama 36305
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Erie, Pennsylvania 16507
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Fargo, North Dakota 58122
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Fayetteville, Arkansas 72703
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Fort Worth, Texas 76104
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Greenville, Pennsylvania 16125
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Gresham, Oregon 97030
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Henderson, Nevada 89052
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Houston, Texas 77030
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Huntington Beach, California 92647
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Jackson, Tennessee 38305
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Jonesboro, Arkansas 72401
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Kingsport, Tennessee 37660
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Latrobe, Pennsylvania 15650
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Layton, Utah 84041
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Little Rock, Arkansas 72205
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Long Beach, California 90813
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Longmont, Colorado 80501
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Louisville, Kentucky 40202
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Metairie, Louisiana 70006
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Murray, Utah 84107
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Nampa, Idaho 83686
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New Albany, Indiana 47150
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Newton, Kansas 67114
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Norwich, Connecticut 06360
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Omaha, Nebraska 68131
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Pittsburgh, Pennsylvania 15213
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Provo, Utah 84604
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Raleigh, North Carolina 27614
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Roy, Utah 84067
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Sacramento, California 95815
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Saint Louis, Missouri 63110
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Saint Paul, Minnesota 55101
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San Angelo, Texas 76904
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San Francisco, California 94115
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South Jordan, Utah 84095
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Stevensville, Michigan 49127
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Uniontown, Pennsylvania 15401
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West Covina, California 91790
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Wexford, Pennsylvania 15090
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Wichita, Kansas 67207
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