Safety and Immunogenicity Study of GSK Biologicals' Seasonal Influenza Candidate Vaccine (GSK2321138A)

Completed · Phase 3

Conditions studied: Influenza

In brief

This study is designed to assess the safety and immunogenicity of a GSK Biologicals' investigational vaccine GSK2321138A in adults 18 years old and older. This study is also designed to assess the lot-to-lot consistency of vaccine GSK2321138A. The blinding will be double blind for all groups except for the GSK2604409A Group which will be open.

Key facts

Study ID

NCT01204671

Run by

GlaxoSmithKline

People needed

4659

Starts

2010-10-04

Expected to finish

2011-06-06

Last updated by the study team

2018-09-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• A male or female 18 years of age or older at the time of the first vaccination
• Subjects who the investigator believes can and will comply with the requirements of the protocol.
• Written informed consent obtained from the subject.
• Healthy subjects or those with chronic well-controlled disease as established by physical 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 urine 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 vaccine within 30 days preceding the dose of the study vaccine or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period.
• Administration of an influenza vaccine during the 6 months preceding entry into the study.
• Planned administration / administration of a vaccine not foreseen by the study protocol within 30 days before vaccination and up to Day 21.
• Any contra-indication to intramuscular administration of the influenza vaccines.
• History of hypersensitivity/anaphylaxis to a previous dose of influenza vaccine, history of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
• Any administration of a long-acting immune-modifying drug within 3 months before study start, or planned administration during the study period.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• Acute disease and/or fever at the time of enrolment.
• Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
• History of Guillain-Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
• Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study.
• History of chronic alcohol consumption and/or drug abuse.
• Any condition which, in the opinion of the investigator, prevents the subject from participating in the study
• Pregnant or lactating female.

Where it is running

• GSK Investigational Site — Chandler, Arizona, United States
• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — Newton, Kansas, United States
• GSK Investigational Site — Lexington, Kentucky, United States
• GSK Investigational Site — Columbia, Maryland, United States
• GSK Investigational Site — Milford, Massachusetts, United States
• GSK Investigational Site — Las Vegas, Nevada, United States
• GSK Investigational Site — Salisbury, North Carolina, United States
• GSK Investigational Site — Erie, Pennsylvania, United States
• GSK Investigational Site — Nashville, Tennessee, United States
• GSK Investigational Site — Tübingen, Baden-Wurttemberg, Germany
• GSK Investigational Site — Augsburg, Bavaria, Germany
• GSK Investigational Site — Haag, Bavaria, Germany
• GSK Investigational Site — Finsterwalde, Brandenburg, Germany
• GSK Investigational Site — Frankfurt am Main, Hesse, Germany
• GSK Investigational Site — Mainz, Rhineland-Palatinate, Germany
• GSK Investigational Site — Dresden, Saxony, Germany
• GSK Investigational Site — Dresden, Saxony, Germany
• GSK Investigational Site — Dresden, Saxony, Germany
• GSK Investigational Site — Freiberg, Saxony, Germany
• GSK Investigational Site — Berlin, Germany
• GSK Investigational Site — Berlin, Germany
• GSK Investigational Site — Brasov, Romania
• GSK Investigational Site — Brăila, Romania
• GSK Investigational Site — Bucharest, Romania

Full record on ClinicalTrials.gov

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