A Phase II, Open-Label, Uncontrolled, Single Center Study to Evaluate Safety and Immunogenicity of FLUVIRIN® Surface Antigen, Inactivated Influenza Vaccine, Formulation 2006-2007, when Administered to Non-Elderly Adult and Elderly Subjects - FLUVIRIN® 2006/2007 Seasonal Trial
- Conditions
- Prophylaxis of influenza
- Registration Number
- EUCTR2006-000787-88-GB
- Lead Sponsor
- Chiron Vaccines Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
Subjects eligible for enrollment into this study are male and female adult volunteers who are:
1.18 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;
Informed consent must be obtained for all the subjects before enrollment in the study.
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) yes
F.1.3.1 Number of subjects for this age range
Individuals are not to be enrolled into the study if:
1.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.women who are pregnant, or women able to bear children but not willing to practice acceptable contraception for the duration of the trial (21 days);
8.within the past 12 months, they have:
· received more than one injection of influenza vaccine;
9.within the past 6 months, they have:
· had laboratory confirmed influenza disease;
· received influenza vaccine;
10.within the past 4 weeks they have received:
· another vaccine;
· any investigational agent;
11.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);
12.they have experienced an acute exacerbation of a COPD (chronic obstructive pulmonary disease) within the past 14 days;
13.within the past 3 days, they have experienced:
· fever (i.e., body temperature = 38°C);
14.they are taking part in another clinical study;
15.they have any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objective.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method