Study to Assess the Immunogenicity and Safety of an Investigational Influenza Vaccine in Children

Completed · Phase 3

Conditions studied: Influenza

In brief

The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational vaccine GSK1557482A.

Key facts

Study ID

NCT00980005

Run by

GlaxoSmithKline

People needed

2116

Starts

2009-10-13

Expected to finish

2010-06-17

Last updated by the study team

2018-09-21

Who can join

Age: 3 and older, up to 17. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Birmingham, Alabama, United States
• GSK Investigational Site — Benton, Arkansas, United States
• GSK Investigational Site — Huntington Beach, California, United States
• GSK Investigational Site — Paramount, California, United States
• GSK Investigational Site — West Covina, California, United States
• GSK Investigational Site — Marietta, Georgia, United States
• GSK Investigational Site — Woodstock, Georgia, United States
• GSK Investigational Site — DeKalb, Illinois, United States
• GSK Investigational Site — Newton, Kansas, United States
• GSK Investigational Site — Wichita, Kansas, United States
• GSK Investigational Site — Woburn, Massachusetts, United States
• GSK Investigational Site — Stevensville, Michigan, United States
• GSK Investigational Site — St Louis, Missouri, United States
• GSK Investigational Site — Henderson, Nevada, United States
• GSK Investigational Site — Cortland, New York, United States
• GSK Investigational Site — Syracuse, New York, United States
• GSK Investigational Site — Cary, North Carolina, United States
• GSK Investigational Site — Raleigh, North Carolina, United States
• GSK Investigational Site — Austintown, Ohio, United States
• GSK Investigational Site — Albany, Oregon, United States
• GSK Investigational Site — Erie, Pennsylvania, United States
• GSK Investigational Site — Hermitage, Pennsylvania, United States
• GSK Investigational Site — Charleston, South Carolina, United States
• GSK Investigational Site — Austin, Texas, United States
• GSK Investigational Site — Houston, Texas, United States

Full record on ClinicalTrials.gov

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