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

Completed · Phase 2

Conditions studied: Influenza

In brief

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.

Key facts

Study ID

NCT01974895

Run by

GlaxoSmithKline

People needed

316

Starts

2013-10-23

Expected to finish

2014-07-03

Last updated by the study team

2018-09-07

Who can join

Age: 1 and older, up to 3. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Sacramento, California, United States
• GSK Investigational Site — West Covina, California, United States
• GSK Investigational Site — Altamonte Springs, Florida, United States
• GSK Investigational Site — Fall River, Massachusetts, United States
• GSK Investigational Site — Woburn, Massachusetts, United States
• GSK Investigational Site — Stevensville, Michigan, United States
• GSK Investigational Site — Syracuse, New York, United States
• GSK Investigational Site — Cleveland, Ohio, United States
• GSK Investigational Site — Hermitage, Pennsylvania, United States
• GSK Investigational Site — Barnwell, South Carolina, United States
• GSK Investigational Site — Cheraw, South Carolina, United States
• GSK Investigational Site — Fort Worth, Texas, United States

Full record on ClinicalTrials.gov

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