A phase II, controlled, randomized, single centre, single blind study to evaluate the immunogenicity, safety and reactogenicity of the low dose influenza vaccine with various doses of AS03 adjuvant compared to Fluarix™ (GlaxoSmithKline Biologicals) administered intramuscularly in subjects aged 18-59 years old. - FLU-LD-004

• Conditions: Immunization against influenza in male and female subjects aged 18-59 years old.

• Registration Number: EUCTR2006-003769-15-BE
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08-03
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

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

Inclusion Criteria

A male or female aged 18-59 years old at the time of the vaccination.

Free of obvious health problems 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
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) no
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 or chronic 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 three months preceding the dose of study vaccine or planned administration during the study period.
•Administration of other licensed vaccines within 30 days prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol during the study period.
•History of hypersensivity to a previous dose of influenza vaccine.
•Previous vaccination against influenza in 2006.
•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
•Pregnancy.
•Acute disease at the time of enrolment. History of administration of an experimental/licensed vaccine containing squalene and/or tocopherol (Vitamin E) within the last 12 Months.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the humoral immune response (anti-haemagglutinin antibody titres) elicited by the low dose influenza vaccine adjuvanted with AS03 (full or half dose of AS03) and by Fluarix given intramuscularly in subjects aged 18-59 years old, 21 days following vaccination. ;Secondary Objective: To assess the safety and reactogenicity of the low dose influenza vaccine adjuvanted with AS03 (full or half dose of AS03) and Fluarix during 30 days following the intramuscular administration of the vaccines in subjects aged 18-59 years old. ;Primary end point(s): •At days 0 and 21: serum haemagglutination-inhibition (HI) antibody titre, against each of the three vaccine strains, in each group.