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

Use our guide to learn which trials are right for you!

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
Syracuse, New York 13210
?
mi
from
Syracuse, NY
Click here to add this to my saved trials
Albany, Oregon 97322
?
mi
from
Albany, OR
Click here to add this to my saved trials
Austin, Texas 78705
?
mi
from
Austin, TX
Click here to add this to my saved trials
Austintown, Ohio 44515
?
mi
from
Austintown, OH
Click here to add this to my saved trials
Benton, Arkansas 72019
?
mi
from
Benton, AR
Click here to add this to my saved trials
Birmingham, Alabama 35249
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Burke, Virginia 22015
?
mi
from
Burke, VA
Click here to add this to my saved trials
Cary, North Carolina 27518
?
mi
from
Cary, NC
Click here to add this to my saved trials
Charleston, South Carolina 29425
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Cortland, New York 14850
?
mi
from
Cortland, NY
Click here to add this to my saved trials
DeKalb, Illinois 60115
?
mi
from
DeKalb, IL
Click here to add this to my saved trials
Erie, Pennsylvania 16507
?
mi
from
Erie, PA
Click here to add this to my saved trials
Henderson, Nevada 89052
?
mi
from
Henderson, NV
Click here to add this to my saved trials
Hermitage, Pennsylvania 16148
?
mi
from
Hermitage, PA
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
Huntington Beach, California 92647
?
mi
from
Huntington Beach, CA
Click here to add this to my saved trials
Marietta, Georgia 30060
?
mi
from
Marietta, GA
Click here to add this to my saved trials
Newton, Kansas 67114
?
mi
from
Newton, KS
Click here to add this to my saved trials
Orem, Utah 84058
?
mi
from
Orem, UT
Click here to add this to my saved trials
Paramount, California 90723
?
mi
from
Paramount, CA
Click here to add this to my saved trials
Provo, Utah 84604
?
mi
from
Provo, UT
Click here to add this to my saved trials
Raleigh, North Carolina 27614
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
Saint Louis, Missouri 63110
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Stevensville, Michigan 49127
?
mi
from
Stevensville, MI
Click here to add this to my saved trials
West Covina, California 91790
?
mi
from
West Covina, CA
Click here to add this to my saved trials
Wichita, Kansas 67207
?
mi
from
Wichita, KS
Click here to add this to my saved trials
Woburn, Massachusetts 01801
?
mi
from
Woburn, MA
Click here to add this to my saved trials
Woodstock, Georgia 30189
?
mi
from
Woodstock, GA
Click here to add this to my saved trials