Active influenza immunoprofilaxis MedDRA version: 9.1 Level: LLT Classification code 10059429 Term: Influenza immunisation
Conditions
Interventions
Trade Name: FLUAD*1SIR 0,5ML 2006-2007
Pharmaceutical Form: Powder for suspension for injection
INN or Proposed INN: Influenza, purified antigen
Concentration unit: µg microgram(s)
Concentration type:
Sponsors
NOVARTIS VACCINES AND DIAGNOSTICS S.R.L.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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: (i)medical history; (ii)physical examination; (iii)clinical judgment of the investigator; 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 F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.any serious disease such as: ?cancer (leukemia, lymphomas, neoplasm) except for benign or localized skin cancer and non metastatic prostate cancer not presently treated with chemotherapy; ?autoimmune disease (including rheumatoid arthritis); ?advanced arteriosclerotic disease or insulin dependent diabetes mellitus; ?chronic obstructive pulmonary disease (COPD) that requires oxygen therapy; ?acute or progressive hepatic disease; ?acute or progressive renal disease; ?congestive heart failure; 2.hypersensitive to ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and neomycin sulphate or any other component of the vaccine; 3. they have a history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine; 4. 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: ?receipt of immunosuppressive therapy (any parenteral or oral cortical steroid or cancer chemotherapy/radiotherapy) within the past 60 days and/or for the full length of the study; ?receipt of immunostimulants; ?receipt 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; 5. they have a known or suspected history of drug or alcohol abuse; 6. 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; 7. within the past 12 months, they have: ?received more than one injection of influenza vaccine; 8. within the past 6 months, they have: ?had laboratory confirmed influenza disease; ?received influenza vaccine, 9. within the past 4 weeks they have received: ?another vaccine; ?any investigational agent; 10. within the past 7 days, they have experienced: ?any acute disease; ?infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable); 11. they have experienced an acute exacerbation of a COPD (chronic obstructive pulmonary disease) within the past 14 days; 12. within the past 3 days, they have experienced: ?fever (i.e., axillary temperature >= 38?C); 13.they are taking part in another clinical study.
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-vaccination in elderly subjects in compliance with the requirements of the current EU recommendations for the evaluation of the immunogenicity for a new formulation of a licensed flu vaccine (CPMP/BWP/214/96).;Secondary Objective: Valutare la sicurezza della somministrazione di una singola iniezione intramuscolare (IM) di FLUAD in soggetti anziani.;Primary end point(s): For each strain at least one of the following assessments should meet the indicated requirements : - number of seroconversions1 or significant increase in antibody titer2 > 30% - mean geometric increase > 2.0 - the proportion of subjects achieving an SRH area ? 25 mm2 should be > 60% | — |
Countries
Italy
Outcome results
None listed