A Phase III, open, non-randomized, multi-centric, single dose study to assess immunogenicity and safety of Fluarix™ (Influsplit SSW®) 2007/2008 injected intramuscularly in young adults (18 to 60 years) and in elderly (over 60 years). - Fluarix-064

• Conditions: Immunization against influenza of healthy adults; MedDRA version: 9.1Level: LLTClassification code 10016794Term: Flu vaccination

• Registration Number: EUCTR2007-001828-12-DE
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04-16
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

All subjects must satisfy the following criteria at study entry:
•Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) 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, i.e. have a current tubal ligation, hysterectomy, ovariectomy or be post-menopausal, 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 the duration of the study

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. (For corticosteroids, this will mean prednisone, or equivalent, ? 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
•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 disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature <37.5°C / Axillary temperature <37.5°C)
•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