Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine (GSK2282512A) Compared to Fluzone® Quadrivalent in Children 6 to 35 Months of Age



Status:Completed
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any
Updated:9/9/2018
Start Date:October 1, 2014
End Date:June 23, 2015

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Immunogenicity and Safety Study of GSK Biologicals' Quadrivalent Influenza Vaccine (GSK2282512A) Compared to Fluzone® Quadrivalent in Children 6 to 35 Months of Age

The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals'
quadrivalent influenza vaccine (GSK2282512A) compared to Sanofi Pasteur's Fluzone®
Quadrivalent in children 6 to 35 months of age.


Inclusion Criteria:

- Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion
of the investigator, can and will comply with the requirements of the protocol.

- A male or female between, and including, 6 and 35 months of age at the time of the
first vaccination.

- Written informed consent obtained from the parent(s)/LAR(s) of the subject.

- Subjects in stable health as determined by investigator's clinical examination and
assessment of subject's medical history.

- Subjects are eligible regardless of history of administration of influenza vaccine in
a previous season.

Exclusion Criteria:

- Use of any investigational or non-registered product (drug or vaccine) other than the
study vaccine within 30 days preceding the first dose of study vaccine, or planned use
during the study period. Routine registered childhood vaccinations are permitted.

- Child in care.

- Chronic administration (defined as more than 14 days in total) of immunosuppressants
or other immune-modifying drugs within six months prior to the first vaccine dose. For
corticosteroids, this will mean a dose equivalent to either > 2 mg/kg/day of body
weight, or to ≥ 20 mg/day of prednisone for persons who weigh ≥ 10 kg, when
administered for more than 2 weeks. Inhaled and topical steroids are allowed.

- Prior receipt of any seasonal or pandemic influenza vaccine (registered or
investigational) within six months preceding the first dose of study vaccine, or
planned use during the study period.

- Administration of immunoglobulins and/or any blood products within the three months
preceding the first dose of study vaccine or planned administration during the study
period.

- History of Guillain-Barré syndrome within six weeks of receipt of prior influenza
vaccine.

- Any known or suspected allergy to any constituent of influenza vaccines (including egg
proteins); a history of anaphylactic-type reaction to consumption of eggs; or a
history of severe adverse reaction to a previous influenza vaccine.

- Acute disease and/or fever at the time of enrolment.

- Fever is defined as temperature ≥ 38.0°C/100.4°F by any route.

- Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory
infection) without fever may be enrolled at the discretion of the investigator.

- Any significant disorder of coagulation or treatment with warfarin derivatives or
heparin.

- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
medical history and physical examination.

- Any other condition which, in the opinion of the investigator, prevents the subject
from participating in the study.
We found this trial at
64
sites
Fort Worth, Texas 76104
348
mi
from
Fort Worth, TX
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Anaheim, California 92807
1148
mi
from
Anaheim, CA
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Augusta, Kansas 67010
46
mi
from
Augusta, KS
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Austin, Texas 78705
515
mi
from
Austin, TX
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Beavercreek, Ohio 45434
754
mi
from
Beavercreek, OH
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Binghamton, New York 13901
1195
mi
from
Binghamton, NY
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Birmingham, Alabama 35249
676
mi
from
Birmingham, AL
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Bossier City, Louisiana 71111
429
mi
from
Bossier City, LA
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Charleston, South Carolina 29425
1063
mi
from
Charleston, SC
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Charlottesville, Virginia 22903
1053
mi
from
Charlottesville, VA
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Cheraw, South Carolina 29520
1020
mi
from
Cheraw, SC
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Chino, California 91710
1138
mi
from
Chino, CA
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Cleveland, Ohio 44195
898
mi
from
Cleveland, OH
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Colorado Springs, Colorado 80910
383
mi
from
Colorado Springs, CO
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Columbia, Maryland 21044
1134
mi
from
Columbia, MD
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Daly City, California 94015
1344
mi
from
Daly City, CA
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Dayton, Ohio 45420
749
mi
from
Dayton, OH
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Dothan, Alabama 36305
833
mi
from
Dothan, AL
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Ellensburg, Washington 98926
1317
mi
from
Ellensburg, WA
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Erie, Pennsylvania 16507
984
mi
from
Erie, PA
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Fresno, California 93720
1205
mi
from
Fresno, CA
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Galveston, Texas 77555
608
mi
from
Galveston, TX
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Hayward, California 94545
1324
mi
from
Hayward, CA
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Hermitage, Pennsylvania 16148
955
mi
from
Hermitage, PA
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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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Lake Mary, Florida 32736
1121
mi
from
Lake Mary, FL
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Las Vegas, Nevada 89102
963
mi
from
Las Vegas, NV
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Layton, Utah 84041
788
mi
from
Layton, UT
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Lincoln, Nebraska 68510
220
mi
from
Lincoln, NE
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Lincoln, Nebraska 68510
220
mi
from
Lincoln, NE
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Lincoln, Nebraska 68510
220
mi
from
Lincoln, NE
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Louisville, Kentucky 40202
657
mi
from
Louisville, KY
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Marshfield, Wisconsin 54449
621
mi
from
Marshfield, WI
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Metairie, Louisiana 70006
688
mi
from
Metairie, LA
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Miami Lakes, Florida 33014
1309
mi
from
Miami Lakes, FL
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Nampa, Idaho 83686
1057
mi
from
Nampa, ID
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Newton, Kansas 67114
33
mi
from
Newton, KS
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Oakland, California 94611
1327
mi
from
Oakland, CA
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Orem, Utah 84058
764
mi
from
Orem, UT
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Paramount, California 90723
1167
mi
from
Paramount, CA
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Payson, Utah 84651
763
mi
from
Payson, UT
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Philadelphia, Pennsylvania 19104
1223
mi
from
Philadelphia, PA
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Pleasanton, California 94588
1312
mi
from
Pleasanton, CA
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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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Sacramento, California 95815
1280
mi
from
Sacramento, CA
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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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Salt Lake City, Utah 84132
777
mi
from
Salt Lake City, UT
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San Nicolas de los Garza, Nuevo León 66480
?
mi
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San Nicolas de los Garza,
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Santa Clara, California 95051
1319
mi
from
Santa Clara, CA
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Sellersville, Pennsylvania 18960
1218
mi
from
Sellersville, PA
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South Jordan, Utah 84095
779
mi
from
South Jordan, UT
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Syracuse, New York 13210
1194
mi
from
Syracuse, NY
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Tomball, Texas 77375
543
mi
from
Tomball, TX
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Topeka, Kansas 66604
144
mi
from
Topeka, KS
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Tucson, Arizona 85724
833
mi
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Tucson, AZ
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Walnut Creek, California 94596
1317
mi
from
Walnut Creek, CA
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West Covina, California 91790
1151
mi
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West Covina, CA
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Wichita, Kansas 67207
32
mi
from
Wichita, KS
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Woburn, Massachusetts 01801
1440
mi
from
Woburn, MA
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