A phase II, open, controlled study to evaluate the reactogenicity and the immunogenicity of GlaxoSmithKline Biologicals AS25 adjuvanted influenza vaccine (FluAS25) in elderly adults (=67 years) previously vaccinated in the FluAS25-014 clinical trial with the same candidate vaccine. Fluarix™ (known as a-Rix® in Belgium) will be used as reference. - FluAS25-018 EXT 001 Y3

GlaxoSmithKline Biologicals0 sites74 target enrollmentAugust 24, 2007

ConditionsImmunization against influenza in male and female subjects aged 67 years and older.

DrugsFluarix/Alpha-Rix

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Immunization against influenza in male and female subjects aged 67 years and older.
Sponsor: GlaxoSmithKline Biologicals
Enrollment: 74
Status: Active, not recruiting
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 24, 2007

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

GlaxoSmithKline Biologicals

Eligibility Criteria

Inclusion Criteria

•Subjects who were previously vaccinated with GlaxoSmithKline Biologicals Fluarix™ or FluAS25 vaccines in the FluAS25\-014 study.
•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, reporting by phone) should be enrolled in the study.
•A male or female aged 67 years or older at the time of re\-vaccination; who previously received FluAS25 or Fluarix™ during FluAS25\-014 clinical trial.
•Written informed consent obtained from the subject.
•Free of an acute aggravation of the health status as established by clinical evaluation (medical history and medical history directed 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

Exclusion Criteria

•Use of any investigational or non\-registered product (drug or vaccine) other than the study vaccines within 30 days prior to vaccination, or planned use 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 21 days after vaccination.
•History of confirmed influenza infection since the date of previous vaccination.
•Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
•Vaccination against influenza since January 2007 with the Northern Hemisphere 2007/2008 influenza vaccine or 2006/2007 influenza vaccine.
•Chronic administration (defined as more than 14 days) of immunosuppressants or other immune\-modifying drugs within six months prior to the administration of the study vaccine. (For corticosteroids, this will mean prednisone, or equivalent, 0\.5 mg/kg/day or more. 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).
•History of hypersensivity to a previous dose of influenza vaccine.
•History of allergy or reactions likely to be exacerbated by any component of the vaccine(s) including egg, chicken protein, formaldehyde, gentamicin sulphate, thiomersal or sodium deoxycholate and adjuvant AS25 (containing squalene, alpha\-tocopherol, Tween 80 and MPL).
•Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by clinical evaluation (medical history and medical history directed physical examination) or pre\-existing laboratory screening tests.