Study to Evaluate Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine GSK2282512A When Administered to Children From 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 23, 2013
End Date:July 3, 2014

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

The purpose of this study is to evaluate the immunogenicity and safety of the new influenza
vaccine GSK2282512A (FLU Q-QIV) and compare its activity to Sanofi Pasteur's Fluzone® (TIV)
in children 6 to 35 months of age.

The subjects will be randomised (1:1) in the two treatment groups (Q-QIV and TIV-YB) to
explore response to vaccination.

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 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 of immunosuppressants or other immune-modifying drugs within
six months prior to the first vaccine dose. For corticosteroids, this will mean
prednisone ≥ 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.

- Prior receipt of any seasonal or pandemic influenza vaccine 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; 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 enrollment.

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

- Subjects with a minor illness 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
12
sites
Altamonte Springs, Florida 32714
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Altamonte Springs, FL
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Barnwell, South Carolina 29812
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Barnwell, SC
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Cheraw, South Carolina 29520
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Cheraw, SC
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Cleveland, Ohio 44195
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Cleveland, OH
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Fall River, Massachusetts 02720
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Fall River, MA
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Fort Worth, Texas 76104
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Fort Worth, TX
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Hermitage, Pennsylvania 16148
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Hermitage, PA
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Sacramento, California 95815
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Sacramento, CA
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Stevensville, Michigan 49127
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Stevensville, MI
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Syracuse, New York 13210
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Syracuse, NY
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West Covina, California 91790
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West Covina, CA
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Woburn, Massachusetts 01801
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from
Woburn, MA
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