The Flu vaccine is used for active prophilaxisys for the influenza, in subjects with chronic diseases (Hypertension, cardiopatie, BOCD, asthma,renal or hepatic insufficiency, arteriosclerosis and diabetes insulindependent) MedDRA version: 9.1 Level: LLT Classification code 10059429 Term: Influenza immunisation
Conditions
Interventions
Trade Name: FLUAD*1SIR 0,5ML 2006-2007
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Influenza, purified antigen
Concentration unit: µg microgram(s)
Concentration type: equal
Conc
Sponsors
NOVARTIS VACCINES AND DIAGNOSTICS S.R.L.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 18-64- years of age, mentally competent, willing and able to give written informed consent prior to study entry; 2. able to comply with all the study requirements; 3. suffering from at least one of the following chronic diseases: · hypertension · hearth diseases · chronic obstructive pulmonary disease (COPD) or asthma hepatic or renal insufficiency · arteriosclerotic disease or insulin dependent diabetes mellitus 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: Individuals are not to be enrolled into the study if: 1. they are hypersensitive to ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and neomycin sulphate or any other component of the vaccine; 2. they have a history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine; 3. they have a known or suspected (or have a high risk of developing) impairment/ alteration of immune function resulting, for example, from: · receipt of parenteral immunoglobulin preparation, blood products and/or plasma derivates within the past 3 months and/or for the full length of the study; · suspected or known HIV infection or HIV-related disease women who are pregnant, or women who are breast-feeding, or women able to bear children but not willing to practice acceptable contraception for the duration of the trial (21 days); 7. within the past 12 months, they have: · received more than one injection of influenza vaccine;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Immunogenicity Objectives To evaluate the antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) at 21 days post-vaccination in at risk adult 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). Safety Objectives To evaluate the safety of the administration of a single intramuscular (IM) injection of FLUAD in at risk adult subjects. ;Secondary Objective: Not Applicable;Primary end point(s): The measures of immunogenicity for each antigen are: - the geometric mean area (GMA) on Day 0 and Day 21 - the Day 21/Day 0 geometric mean area ratio (GMR) - the percentage of subjects achieving seroconversion1 or significant increase in antibody titer2 - the percentage of subjects achieving an SRH area >= 25 mm2 on Day 0 and Day 21 | — |
Countries
Italy
Outcome results
None listed