A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Seasonal Influenza Vaccine in Children

Completed · Phase 3

Conditions studied: Influenza

In brief

This study is designed to test the immunogenicity and safety of an investigational influenza vaccine, in children compared to two other influenza vaccines.

Key facts

Study ID

NCT01198756

Run by

GlaxoSmithKline

People needed

3109

Starts

2010-10-01

Expected to finish

2011-07-01

Last updated by the study team

2018-09-21

Who can join

Age: 1 and older, up to 17. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects who the investigator believes that they and/or their parent(s) or legally acceptable representative(s) can and will comply with the requirements of the protocol.
• A male or female child aged between 6 months and 17 years inclusive at the time of the first vaccination; children are eligible regardless of history of administration of influenza vaccine in a previous season.
• Written informed consent obtained from the subject/from the parent(s)/legally acceptable representative(s) of the subject.
• Written informed assent obtained from the subject if/as required by local regulations.
• Subjects in stable health as determined by investigator's clinical examination and assessment of subjects' medical history.
• 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 urine 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.

You may not qualify if…

• Child in care
• Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.Prior receipt of any seasonal or pandemic influenza vaccine within 6 months preceding the first dose of study vaccine, or planned use during the study period.
• Chronic administration of immunosuppressants or other immune modifying drugs within six months prior to the first vaccine dose.
• 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.
• History of Guillain-Barré syndrome within 6 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.
• Fever at the time of enrolment.
• Acute disease at the time of enrolment.
• Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin.
• Pregnant or lactating female.
• 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.
• Ongoing aspirin therapy.
• 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 — Chandler, Arizona, United States
• GSK Investigational Site — Scottsdale, Arizona, United States
• GSK Investigational Site — Harrisburg, Arkansas, United States
• GSK Investigational Site — Little Rock, Arkansas, United States
• GSK Investigational Site — Huntington Beach, California, United States
• GSK Investigational Site — Paramount, California, United States
• GSK Investigational Site — Centennial, Colorado, United States
• GSK Investigational Site — Longmont, Colorado, United States
• GSK Investigational Site — Thornton, Colorado, United States
• GSK Investigational Site — Niles, Michigan, United States
• GSK Investigational Site — St Louis, Missouri, United States
• GSK Investigational Site — Omaha, Nebraska, United States
• GSK Investigational Site — Hermitage, Pennsylvania, United States
• GSK Investigational Site — Barnwell, South Carolina, United States
• GSK Investigational Site — Clarksville, Tennessee, United States
• GSK Investigational Site — Fort Worth, Texas, United States
• GSK Investigational Site — Edmonton, Alberta, Canada
• GSK Investigational Site — Surrey, British Columbia, Canada
• GSK Investigational Site — Winnipeg, Manitoba, Canada
• GSK Investigational Site — Mount Pearl, Newfoundland and Labrador, Canada
• GSK Investigational Site — Halifax, Nova Scotia, Canada
• GSK Investigational Site — Brampton, Ontario, Canada
• GSK Investigational Site — Greater Sudbury, Ontario, Canada
• GSK Investigational Site — Hamilton, Ontario, Canada
• GSK Investigational Site — Saskatoon, Saskatchewan, Canada

Full record on ClinicalTrials.gov

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