A phase II, controlled, single centre, open study to evaluate the safety, reactogenicity and immunogenicity of a second vaccination with the low dose influenza vaccine adjuvanted with a reduced dose of AS03, compared to a second dose of Fluarix™ (GlaxoSmithKline Biologicals) administered intramuscularly in subjects 18-60 years previously vaccinated in FLU-LD-004 clinical trial. - FLU-LD-010 EXT: 004 Y1

• Conditions: Re-vaccination against influenza in male and female subjects aged 18-60 years old.

• Registration Number: EUCTR2007-002783-10-BE
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-20
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

•A male or female aged 18-60 years old at the time of vaccination, who previously received either the low dose influenza vaccine adjuvanted with AS03 (whatever the adjuvant dose), or Fluarix during the FLU-LD-004 clinical trial.
•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.
•Written informed consent obtained from the subject.
•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, i.e. either surgically sterilized or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions (i.e. intrauterine contraceptive device; oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream or foam; Norplant® or DepoProvera®) for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.

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 (drug or vaccine) other than the study vaccine within 30 days preceding the administration of the study vaccine, or planned use during the study period.
•Planned administration of an influenza vaccine other than the study vaccines during the entire study period
•Previous vaccination against influenza since January 2007.
•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. (For corticosteroids, this will mean prednisone, or equivalent, = 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
•Administration of immunoglobulins and/or any blood products within three months preceding the dose of study vaccine or planned administration during the study period.
•History of hypersensivity to a previous dose of influenza vaccine.
•History of confirmed influenza infection within the last 12 months.
•Pregnancy.
•History of allergy or reactions likely to be exacerbated by any component of the vaccine(s) including egg, chicken protein, gelatine, formaldehyde, gentamicin sulphate, thimerosal or sodium deoxycholate and adjuvant AS03 (containing squalene, alpha-tocopherol and Tween 80).
•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 diarrhea, 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)).

Study & Design

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