An observational study to investigate the incidence of influenza and influenza-related complications, in adults between 50-64 years and elderly adults 65 years and over vaccinated with GSK Biologicals’ influenza vaccine (Fluarix™) administered intramuscularly - EPI-FLUAS25-002

• Conditions: Immunization against influenza in male and female subjects aged 50 years and over

• Registration Number: EUCTR2006-002897-23-DE
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07-26
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

A male or female age 50 years and over at the time of the first vaccination.
Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g., return for follow-up visits, disease reporting by phone, and completion of PRO instrument (questionnaire) should be enrolled in the study.
Written informed consent obtained from the subject.
Availability to follow up by phone during the study period.
Subjects with residence status allowing free mixing with general community.
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

History of hypersensitivity to a previous dose of influenza vaccine.
History of allergy or reactions likely to be exacerbated by any component of the vaccine including egg, chicken protein, formaldehyde, thimerosal, gentamicin sulfate or sodium deoxycholate.
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Acute disease at the time of enrolment/ vaccination. 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 (99.5°F) / Axillary temperature <37.5°C (99.5°F) / Tympanic temperature on oral setting <37.5°C (99.5°F) / Tympanic temperature on rectal setting <38°C (100.4°F).
Any contra-indication to intramuscular administration of Fluarix™.
Pregnancy
For subjects enrolled in the immunogenicity subset only: Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 7 days prior to the vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, > 0.5 mg/kg/day. Inhaled and topical steroids are allowed.).

Study & Design

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