Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine Versus a Licensed Comparator in Children

Completed · Phase 3

Conditions studied: Influenza

In brief

The purpose of this study is to evaluate the immunogenicity and the safety of GlaxoSmithKline Biologicals' seasonal influenza vaccine, Fluarix, compared to Fluzone (a US-licensed vaccine) in children, 6 to 35 months of age.

Key facts

Study ID

NCT00764790

Run by

GlaxoSmithKline

People needed

3317

Starts

2008-10-01

Expected to finish

2009-06-01

Last updated by the study team

2018-07-31

Who can join

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

You may qualify if…

• A male or female child aged 6 to 35 months 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.
• Subjects having a parent/guardian who the investigator believes can and will comply with the requirements of the protocol.
• Written informed consent obtained from the subject's parent/guardian.

You may not qualify if…

• Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period. Routine, registered childhood vaccinations are not an exclusion criterion.
• History of hypersensitivity to any vaccine.
• History of allergy or reactions likely to be exacerbated by any component of the vaccine.
• Acute disease at the time of enrolment.
• History of Guillain Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
• Receipt of an influenza vaccine outside of this study, during current (2008-09) flu season.
• Administration of immunoglobulins and/or blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.

Where it is running

• GSK Investigational Site — Birmingham, Alabama, United States
• GSK Investigational Site — Dothan, Alabama, United States
• GSK Investigational Site — Benton, Arkansas, United States
• GSK Investigational Site — Conway, Arkansas, United States
• GSK Investigational Site — Fayetteville, Arkansas, United States
• GSK Investigational Site — Jonesboro, Arkansas, United States
• GSK Investigational Site — Little Rock, Arkansas, United States
• GSK Investigational Site — Huntington Beach, California, United States
• GSK Investigational Site — Long Beach, California, United States
• GSK Investigational Site — Paramount, California, United States
• GSK Investigational Site — Sacramento, California, United States
• GSK Investigational Site — San Francisco, California, United States
• GSK Investigational Site — West Covina, California, United States
• GSK Investigational Site — Longmont, Colorado, United States
• GSK Investigational Site — Norwich, Connecticut, United States
• GSK Investigational Site — Nampa, Idaho, United States
• GSK Investigational Site — DeKalb, Illinois, United States
• GSK Investigational Site — New Albany, Indiana, United States
• GSK Investigational Site — Arkansas City, Kansas, United States
• GSK Investigational Site — Newton, Kansas, United States
• GSK Investigational Site — Wichita, Kansas, United States
• GSK Investigational Site — Bardstown, Kentucky, United States
• GSK Investigational Site — Louisville, Kentucky, United States
• GSK Investigational Site — Bossier City, Louisiana, United States
• GSK Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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