Immunization against influenza in male and female subjects aged 50 years and over
Conditions
Interventions
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)/millilitre
Concentra
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A male or female age 50 years and over at the time of the first vaccination. Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g., return for follow-up visits, disease reporting by phone, and completion of PRO instrument (questionnaire) should be enrolled in the study. Written informed consent obtained from the subject. Availability to follow up by phone during the study period. Subjects with residence status allowing free mixing with general community. 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. Acute disease at the time of enrolment/ vaccination. 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 diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature 0.5 mg/kg/day. Inhaled and topical steroids are allowed.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: During the influenza season and during the surveillance period, in subjects >= 50 years, after vaccination with Fluarix™: To evaluate the incidence of laboratory confirmed influenza; laboratory confirmation will be by detection of influenza A and /or B by virus culture and/or RT-PCR in nasal and throat swab specimens To evaluate the incidence of hospitalizations, emergency room visits, or unscheduled medical office visits due to ILI To evaluate the incidence of hospitalizations, emergency room visits or unscheduled medical office visits due to laboratory confirmed influenza To evaluate the frequency of hospitalization or emergency room visit for any cause To evaluate the incidence of pneumonia, ischemic heart disease (unstable angina or myocardial infarction), congestive heart failure, acute cerebrovascular disease and COPD exacerbation To evaluate the mortality due to laboratory confirmed influenza infection To evaluate all-cause mortality in the study cohort ;Secondary Objective: During the influenza season and during the surveillance period, in subjects >= 50 years, after vaccination with Fluarix™: To evaluate the incidence of hospitalizations, emergency room visits, or unscheduled medical office visits due to pneumonia, ischemic heart disease (unstable angina or myocardial infarction), congestive heart failure, acute cerebrovascular disease and COPD exacerbation To evaluate the incidence of laboratory confirmed RSV infection; laboratory confirmation will be by detection of RSV by RT-PCR in nasal and throat swab specimens To assess the baseline functional status and health related quality of life (EQ-5D health questionnaire). To compare it with the one observed at the onset of ILI episode and at Day 30 post ILI episode onset To provide related health economics measures To evaluate the safety of one dose of Fluarix in terms of occurrence of serious adverse events To evaluate the immune response in terms of HI antibody in a subset of subjects >= 50 | — |
Countries
Germany
Outcome results
None listed