A Phase II, Open Label, Uncontrolled, Multi-Center Study to support annual strain update and to Evaluate Safety and Immunogenicity of FLUAD Surface Antigen, Inactivated, (Adjuvanted with MF59C.1) Influenza Vaccine, Formulation 2007-2008, when Administered to Subjects aged 18-64 years affected by chronic diseases - ND

• Conditions: 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: 9.1Level: LLTClassification code 10059429Term: Influenza immunisation

• Registration Number: EUCTR2007-000964-26-IT
• Lead Sponsor: OVARTIS VACCINES AND DIAGNOSTICS S.R.L.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06-07
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br><br><br>;Secondary Objective: Not Applicable;Primary end point(s): The measures of immunogenicity for each antigen are:<br><br>-the geometric mean area (GMA) on Day 0 and Day 21<br><br>-the Day 21/Day 0 geometric mean area ratio (GMR)<br><br>-the percentage of subjects achieving seroconversion1 or significant increase in antibody titer2<br><br>-the percentage of subjects achieving an SRH area >= 25 mm2 on Day 0 and Day 21