A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of FLUAD Surface Antigen, Inactivated, (Adjuvanted with MF59C.1) Influenza Vaccine, Formulation 2007-2008, when Administered to Elderly Subjects - ND

Conditions: MedDRA version: 9.1Level: LLTClassification code 10059429Term: Influenza immunisation
Active influenza immunoprofilaxis

Registration Number: EUCTR2007-000966-19-IT

Lead Sponsor: OVARTIS VACCINES AND DIAGNOSTICS S.R.L.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 :<br><br>- number of seroconversions1 or significant increase in antibody titer2 > 30%<br><br>- mean geometric increase > 2.0<br><br>- the proportion of subjects achieving an SRH area ? 25 mm2 should be > 60%

Secondary Outcome Measures

Name	Time	Method