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

GlaxoSmithKline Biologicals0 sites120 target enrollmentApril 28, 2006

Overview

No summary available.

Registry

who.int

Start Date

April 28, 2006

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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

•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)