Immunogenicity, Safety and Tolerability of Two Doses of FLUAD-H5N1 Influenza Vaccine in Adult and Elderly Subjects
Phase 3
Completed
- Conditions
- Influenza
- Registration Number
- NCT00434733
- Lead Sponsor
- Novartis
- Brief Summary
This study is designed to evaluate the immunogenicity, safety and tolerability of 2 doses of FLUAD-H5N1 vaccine compared to 2 doses of trivalent, interpandemic FLUAD, each administered 3 weeks apart.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4400
Inclusion Criteria
- Healthy Subjects 18 years of age who signed the informed consent
Exclusion Criteria
- Receipt of another investigational agent within 4 weeks
- Receipt of influenza vaccination for current season 2006/2007.
- any acute disease or infection, history of neurological symptoms or signs, known or suspected impairment of immune function, any serious disease, bleeding diathesis
- fever (defined as axillary temperature ³38.0°C) within 3 days (prior to Visit 1)
- Pregnant or breastfeeding or females of childbearing potential who refuse to use an acceptable method of birth control
- Surgery planned during the study period
- Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the study vaccine
- Receipt of another vaccine within 3 weeks prior to Visit 1 or planned vaccination within 3 weeks following the last study vaccination
- History of (or current) drug or alcohol abuse
- Any condition, which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Adverse event rate
- Secondary Outcome Measures
Name Time Method Seroconversion and seroprotection after two doses of H5N1 vaccine
Trial Locations
- Locations (1)
Centrum Badań Farmakologii Klinicznej monipol
🇵🇱Kraków, Poland