Study to Assess the Immunogenicity and Safety of an Investigational Influenza Vaccine in Children



Status:Completed
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:3 - 17
Updated:9/23/2018
Start Date:October 13, 2009
End Date:June 17, 2010

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Immunogenicity & Safety Study of GSK Biologicals' Thimerosal-free Trivalent Influenza Vaccine (TIV) Versus a Licensed Comparator in Children

The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals'
investigational vaccine GSK1557482A.


Inclusion Criteria:

- Subjects and/or subject parent(s)/Legally Acceptable Representative(s) (LAR) who the
investigator believes can and will comply with the requirements of the protocol.

- A male or female child aged between 3 years and 17 years of age 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.

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

- Healthy subjects as established by medical history and history-directed clinical
examination before entering into the study.

- Female subjects of non-childbearing potential may be enrolled in the study.

- Female subjects of childbearing potential may be enrolled in the study, if the
subject:

- has practiced adequate contraception for 30 days prior to vaccination, and

- has a negative pregnancy test on the day of vaccination, and

- has agreed to continue adequate contraception during the entire treatment period and
for 2 months after completion of the vaccination series.

Exclusion Criteria:

- Use of any investigational or non-registered product other than the study vaccines
within 30 days preceding the administration of the study vaccine, or planned use
during the study period. Routine, registered childhood vaccinations or registered and
recommended pandemic influenza vaccine are not an exclusion.

- Receipt of a seasonal influenza vaccine outside of this study, during current
(2009-2010) flu season.

- Child in care

- Receipt of systemic glucocorticoids within 1 month prior to study enrollment, or any
other cytotoxic or immunosuppressive drug within 6 months of study enrollment.
Topical, intra-articular or inhaled glucocorticoids are allowed.

- Concurrently participating in another clinical study, at any time during the study
period, in which the subject has been or will be exposed to an investigational or a
non-investigational product.

- History of hypersensitivity to any vaccine.

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

- History of any reaction or hypersensitivity likely to be exacerbated by any component
of the vaccine(s).

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

- Administration of immunoglobulins and/or any blood products within the 3 months
preceding the first dose of study vaccine or planned administration during the study
period.

- Pregnant or lactating female.

- History of chronic alcohol consumption and/or drug abuse.

- Female planning to become pregnant or planning to discontinue contraceptive
precautions.

- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
medical history and physical examination.
We found this trial at
28
sites
Saint Louis, Missouri 63110
397
mi
from 43215
Saint Louis, MO
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Albany, Oregon 97322
2052
mi
from 43215
Albany, OR
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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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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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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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Cortland, New York 14850
399
mi
from 43215
Cortland, NY
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DeKalb, Illinois 60115
328
mi
from 43215
DeKalb, IL
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Erie, Pennsylvania 16507
214
mi
from 43215
Erie, PA
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Henderson, Nevada 89052
1755
mi
from 43215
Henderson, NV
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Hermitage, Pennsylvania 16148
160
mi
from 43215
Hermitage, PA
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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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Marietta, Georgia 30060
423
mi
from 43215
Marietta, GA
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Newton, Kansas 67114
779
mi
from 43215
Newton, KS
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Orem, Utah 84058
1508
mi
from 43215
Orem, UT
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Paramount, California 90723
1972
mi
from 43215
Paramount, CA
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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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Stevensville, Michigan 49127
230
mi
from 43215
Stevensville, MI
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Syracuse, New York 13210
414
mi
from 43215
Syracuse, NY
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West Covina, California 91790
1955
mi
from 43215
West Covina, CA
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Wichita, Kansas 67207
780
mi
from 43215
Wichita, KS
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Woburn, Massachusetts 01801
640
mi
from 43215
Woburn, MA
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Woodstock, Georgia 30189
413
mi
from 43215
Woodstock, GA
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