A phase IIb, controlled, randomized, multicenter, observer blinded study to evaluate the immunogenicity, safety and reactogenicity of a second vaccination with the low dose influenza vaccine adjuvanted with AS03 compared to a second dose of Fluarix™ (GlaxoSmithKline Biologicals) administered intramuscularly in elderly >=60 years previously vaccinated in FLU-LD-002 clinical trial. - FLU-LD-007

Phase 1

• Conditions: Re-vaccination against influenza in male and female subjects aged 60 years and older.

• Registration Number: EUCTR2006-003815-31-NO
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08-09
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

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

Inclusion Criteria

A male or female age 60 years or older at the time of the revaccination, who previously received either the low dose adjuvanted (AS03) influenza vaccine or Fluarix during the FLU-LD-002; FLU-LD-006 EXT-002 (D180) clinical trial.

Free of an acute aggravation of the health status as established by clinical examination before entering into the study.

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

•Use of any investigational or non-registered product within 30 days preceding the administration of the study vaccine, or planned use during the study period.
•Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
•Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
•Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
•Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 30 days after vaccination.
•History of hypersensivity to a previous dose of influenza vaccine.
•History of confirmed influenza infection within the last 12 months.
•History of allergy or reactions likely to be exacerbated by any component of the vaccines.
•Acute disease at the time of enrolment.

Study & Design

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