A Study for Evaluation of Immunogenicity and Reactogenicity of FluarixTM / Influsplit SSW® 2009/2010 in Adults

A Phase III Study for Evaluation of Immunogenicity and Reactogenicity of FluarixTM / Influsplit SSW® 2009/2010 in People Aged 18 Years or Above

This study is designed to test the immunogenicity and reactogenicity of the FluarixTM/Influsplit SSW® influenza vaccine containing the influenza strains recommended for the 2009-2010 season.

Inclusion Criteria:

• Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
• A male or female aged 18 years or above at the time of the vaccination.
• Written informed consent obtained from the subject.
• Healthy subjects or with well-controlled chronic diseases as established by medical history and clinical examination before entering into the study.
• If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.

Exclusion Criteria:

• Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the vaccination or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.
• Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned during the study.
• Administration of an influenza vaccine within 6 months preceding the study start.
• Administration of an influenza vaccine other than the study vaccine during the entire study
• Clinically or virologically confirmed influenza infection within 6 months preceding the study start
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• Acute disease at the time of enrolment.
• Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
• Not stabilized or clinically serious chronic underlying disease.
• Lactating female.
• History of chronic alcohol consumption and/or drug abuse.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.