Immunization against influenza in male and female subjects aged 18 to 64 years
Conditions
Interventions
Trade Name: Fluarix
Product Name: Fluarix
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Haemagglutinin from A/New Caledonia/20/99 (IVR-116)
Concentration unit: µg/ml microgram(s)/
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •A male or female age between, and including, 18 and 64 years of age at the time of the vaccination. •Written informed consent obtained from the subject. •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
Exclusion criteria: •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding vaccination or planned use during the study period. •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, chicken protein, formaldehyde, thimerosal, gentamicin sulfate or sodium deoxycholate. •Acute disease at the time of enrollment. (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). •Administration of any other influenza vaccine for the season 2006-2007. •Pregnancy. •Chronic disorders of the pulmonary or cardiovascular system, including asthma. •History of requiring regular medical follow-up or hospitalization during the preceding year because of chronic metabolic diseases (including diabetes mellitus), renal dysfunction, hemoglobinopathies, asthma or immunosuppression (including immunosuppression caused by medications or by human immunodeficiency virus). •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to vaccination (for corticosteroids, this will mean prenisone, or equivalent, ? 0.5mg/kg/day). •Administration of immunoglobulins and/or any blood products within three months prior to vaccination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the efficacy of Fluarix™ in the prevention of culture confirmed influenza A and/or B cases, for vaccine antigenically matched strains, when compared to the placebo group.;Secondary Objective: To evaluate the efficacy of Fluarix: - in the prevention of culture confirmed influenza A and/or B cases, for any influenza strain compared to placebo - in the prevention of all influenza like illness - in the prevention of laboratory confirmed influenza cases, for any influenza strain - in the prevention of laboratory confirmed influenza cases, for vaccine antigenically matched strains - in the prevention of culture confirmed influenza cases, for vaccine antigenically matched strains, for each lot of vaccine administered To evaluate the severity of culture confirmed influenza To evaluate the incidence of pneumonia related to influenza To evaluate the incidence of any pneumonia To evaluate the immunogenicity of Fluarix approximately 21 days post-vaccination, in a subset of subjects To evaluate the safety of Fluarix in terms of unsolicited symptoms during 21 days post-vaccination in a subset of subjects and serious adverse events in all subjects ;Primary end point(s): Occurrence of culture confirmed influenza A and/or B, for vaccine antigenically matched strains | — |
Countries
Czech Republic, Finland
Outcome results
None listed