A Phase III study for evaluation of immunogenicity and reactogenicity of Fluarix™ (Influspit SSW®) 2006/2007 in people aged 18 years or above - Flu-063

• Conditions: immunization against influenza of healthy adults

• Registration Number: EUCTR2006-001918-33-DE
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04-28
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

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-stabilized 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the vaccination or planned use during the study period.
•Chronic administration (defined as more than 14 days) 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 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
•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 (such as cancer, chronic obstructive pulmonary disease under oxygen therapy, insuline-dependent diabetes Mellitus)
•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 (no laboratory testing required).
•Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified