A Study for Evaluation of Immunogenicity and Reactogenicity of Fluarix™ / Influsplit SSW® 2008/2009 in Adults

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Influenza

Treatments

Biological: Fluarix™

Study type

Interventional

Funder types

Industry

Identifiers

NCT00706563

111631

Details and patient eligibility

About

This study is designed to test the immunogenicity and reactogenicity of the Fluarix™/Influsplit SSW® influenza vaccine containing the influenza strains recommended for the 2008-2009 season.

Enrollment

120 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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 (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 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 1 year 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 1 year 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