A randomized, observer-blind, active-controlled phase III study to demonstrate the superior efficacy of GSK Biologicals’ adjuvanted influenza candidate vaccine [GSK2186877A], administered intramuscularly in elderly aged 65 years or above, as compared to Fluarix™. - FLU NG-006 PRI

• Conditions: Immunization against influenza in male and female subjects aged 65 years or older.

• Registration Number: EUCTR2008-000872-25-EE
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-04
• Last Update Posted: 17 July 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 43614

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. return for follow-up visits, disease reporting by phone, and completion of questionnaires) should be enrolled in the study. Specific attention should be given to the compliance potential of subjects with suspected drug or alcohol abuse.
•A man or woman aged 65 years or older at the time of the vaccination.
•Written informed consent obtained from the subject.
•Subjects with residence status allowing free mixing with general community.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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

The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:
•Bedridden subjects
•Previous vaccination against influenza since February 2008.
•Previous vaccination in the last three years with an investigational adjuvanted candidate seasonal or pandemic influenza vaccine.
•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.
•Any contra-indication to intramuscular administration of the influenza vaccines.
•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 and chicken protein.
•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 (99.5°F).

Study & Design

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