The virus strains responsible for influenza vary in an unpredictable fashion, therefore the type of virus as well as the magnitude of influenza activity changes from one winter to the other. Therefore it?s necessary continuous monitoring of the influenza epidemic by national surveillance systems. Following the recommendations of these surveillance systems, every year anti-influenza vaccines are produced ad hoc and distributed worldwide according to the new variants of the influenza virus. MedDR
Conditions
Sponsors
NOVARTIS VACCINES AND DIAGNOSTICS S.R.L.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects eligible for enrollment into this study are male and female elderly volunteers who are: 1. 65 years of age or older, mentally competent, willing and able to give written informed consent prior to study entry; 2. able to comply with all the study requirements; 3. in general good health as determined by: - medical history; - physical examination; - clinical judgment of the investigator; Written informed consent must be obtained for all the subjects before enrollment into the study after the nature of the study has been explained 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: 1. They have any serious chronic or acute disease disease (in the judgment of the investigator), including but not limited to: a. Cancer, except for localized skin cancer; b. Advanced congestive heart failure; c. Chronic obstructive pulmonary disease (COPD); d. Autoimmune disease (including rheumatoid arthritis); e. Acute or progressive hepatic disease; f. Acute or progressive renal disease; g. Severe neurological or psychiatric disorder; h. Severe asthma. 2. They have history of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a proven hypersensitivity to any component of the study vaccine (e.g. to ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and neomycin sulphate); 3. They have a known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age) resulting, for example, from: - recipt of immunosuppressive therapy (any parenteral or oral corticosteroid or cancer chemotherapy/radiotherapy) within the past 60 days and for the full length of the study; - recipt of immunostimulants; - recipt of parenteral immunoglobulin preparation, blood products and/or plasma derivates within the past 3 months and for the full length of the study; - suspected or known HIV infection or HIV-related disease; 4. They have a known or suspected history of drug or alcohol abuse; 5. They have a bleeding diathesis or conditions associated with prolonged bleeding time that in the investigator?s opinion would interfere with the safety of the subject; 6. Within the past 12 months, they have: - received more than one injection of influenza vaccine; 7. Within the past 6 months, they have: - had laboratory confirmed influenza disease; - received influenza vaccine; 8. Within the past 4 weeks they have received: - another vaccine; - any investigational agent; 9. They have any acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the last 7 days; 10. They have experienced fever (i.e., axillary temperature ≥ 38C) within the last 3 days; 11. They are taking part in another clinical study; 12. They have any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives; 13. They are severely obese with Body Mass Index (BMI) > 35 Site personnel involved in the evaluation of safety and their immediate relatives are excluded from participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) at 21 days post-immunization in elderly subjects in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines. Antibodies maybe additionally quantified using the hemagglutination inhibition (HI) test for confirmation purposes (Note for Guidance on Harmonisation of Requirements for Influenza Vaccines, CPMP/BWP/214/96: 12 March 1997).;Secondary Objective: Valutare la sicurezza di una singola iniezione intramuscolare (IM) di FLUAD in soggetti anziani in conformita` con i requisiti delle attuali raccomandazioni UE per gli studi clinici in relazione all?approvazione annuale dei vaccini influenzali. (CPMP/BWP/214/96).;Primary end point(s): The following serological assessments should be considered for each strain in elderly subjects, aged over 65, and at least one of the assessments should meet the indicated requirements: ▫ The proportion of subjects achieving seroconversion or significant increase in anti-HA antibody titer should be > 30% ▫ Mean geometric increase should be > 2.0 ▫ The proportion of subjects achieving an HI titer ≥ 40 or SRH titer ≥ 25 mm2 should be > 60%. | — |
Countries
Italy
Outcome results
None listed