EUCTR2006-000610-20-ITActive, not recruitingNot Applicable
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 2006-2007, when Administered to Elderly Subjects - ND
CHIRO0 sitesStarted: July 12, 2007Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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;
- •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
- •they have 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. they are hypersensitive to ovalbumin, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin 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 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., body temperature >= 38?C);
- •13.they are taking part in another clinical study;
- •14.they have any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objective.
Investigators
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