A Phase II, Open-Label, Uncontrolled, Single Center Study to Evaluate Safety and Immunogenicity of FLUVIRIN® [Influenza Vaccine (Surface Antigen, Inactivated) Ph.Eur], Formulation 2008-2009, when Administered to Non-Elderly Adult and Elderly Subjects - FLUVIRIN® 2008-2009 seasonal trial
- Conditions
- Prophylaxis of influenza
- Registration Number
- EUCTR2008-000939-17-GB
- Lead Sponsor
- ovartis Vaccines and Diagnostics Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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. available for all the visits scheduled in the study and able to comply with all study requirements
3. in general good health as determined by:
a) medical history
b) physical examination
c) clinical judgment of the investigator
Written informed consent must be obtained from all the subjects before enrollment in the study after the nature of the study has been explained.
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
Subjects are not to be enrolled into the study if at least one of the following criteria is fulfilled:
1. Any serious (in the judgment of the investigator) disease including, but not limited to:
a. Cancer, except for localized skin cancer
b. Advanced congestive heart failure
c. Chronic Obstructive Pulmonary Disease (COPD)
d. Autoimmune disease (including rheumatoid arthritis)
e. Acute or progressive hepatic disease
f. Acute or progressive renal disease
g. Severe neurological or psychiatric disorder
h. Severe asthma
2. History of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a proven hypersensitivity to any component of the study vaccine (e.g. to ovalbumin, chicken protein, chicken feathers, influenza viral protein, neomycin, polymixin)
3. 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:
a. Receipt of immunosuppressive therapy (any parenteral or oral corticosteroid or cancer chemotherapy/radiotherapy) within the past 60 days and for the full length of the study
b. Receipt of immunostimulants,
c. Receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 3 months and for the full length of the study,
d. Suspected or known HIV infection or HIV-related disease.
4. Known or suspected history of drug or alcohol abuse.
5. The subject has a bleeding diathesis or condition associated with prolonged bleeding time that in the investigator’s opinion would interfere with the safety of the subject.
6. Women who are pregnant or woman of child-bearing potential unwilling to practice acceptable contraception for the duration of the study (21 days).
7. Influenza vaccination or laboratory confirmed influenza within the last 6 months and more than one influenza vaccination within the past 12 months
8. Within the past 4 weeks, the subject has received:
- another vaccine
- any investigational agent
9.Any acute or chronic infection requiring systemic antibiotic treatment or antiviral therapy within the last 7 days.
10. The subject has experienced an acute exacerbation of a COPD within the past 14 days
11. The subject has experienced fever (i.e. axillary temperature =38.0°C) within the last 3 days
12. Severely obese with Body Mass Index (BMI) > 35 kg/m2
13. Any condition, which, in the opinion of the investigator, might prevent the subject from participation or interfere with the evaluation of the study objectives
Site personnel involved in evaluation of safety and their immediate relatives are excluded from participation.
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