A Phase II, Open-Label, Uncontrolled, Single Center Study to Evaluate Safety and Immunogenicity of FLUVIRIN® Surface Antigen, Inactivated Influenza Vaccine, Formulation 2005-2006, when administered to Non-Elderly Adult and Elderly Subjects
- Conditions
- Prophylaxis of influenza
- Registration Number
- EUCTR2005-000659-14-GB
- Lead Sponsor
- Chiron Vaccines Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
Subjects eligible for enrollment into this study are male and female adult volunteers who are:
1.18 years of age or older, mentally competent, and able to give the written
informed consent prior to study entry;
2.able to comply with all the study requirements;
3.in 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 (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 complicated 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 eggs, chicken protein, chicken feathers,
influenza viral protein, thiomersal, 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 in:
·receipt of immunosuppressive therapy (any parenteral or oral
cortical steroid or cancer chemotherapy/radiotherapy)
·receipt of immunostimulants
·receipt of parenteral immunoglobulin preparation, blood
products and/or plasma derivates within the past 3 months
·suspected or known HIV infection or HIV-related disease
5.they have a bleeding diathesis or conditions associated with prolonged
bleeding time;
6.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);
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.within the past 3 days they have experienced:
·fever (i.e., axillary temperature = 38°C);
12.they are taking part in another clinical study;
13.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