Status:
COMPLETED
Immunogenicity, Safety and Tolerability of Two Doses of FLUAD-H5N1 Influenza Vaccine in Adult and Elderly Subjects
Lead Sponsor:
Novartis
Collaborating Sponsors:
Novartis Vaccines
Conditions:
Influenza
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- Healthy Subjects 18 years of age who signed the informed consent
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
4400 Patients enrolled
Trial Details
Trial ID
NCT00434733
Start Date
January 1 2007
Last Update
April 24 2008
Active Locations (1)
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1
Centrum Badań Farmakologii Klinicznej monipol
Krakow, Poland, 30-969