Status:
COMPLETED
Safety and Immunogenicity of Two Doses, Administered Three Weeks Apart, of Two(Surface Antigen Adjuvanted With MF59C.1) Influenza Vaccines in Non-Elderly Adult and Elderly Subjects
Lead Sponsor:
Novartis
Collaborating Sponsors:
Novartis Vaccines
Conditions:
Pandemic Influenza Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The present study aims to evaluate safety and immunogenicity of two doses, administered three weeks apart, of two influenza vaccines containing 7.5 micrograms or 15 micrograms of H5N1 influenza antige...
Eligibility Criteria
Inclusion
- Male and female volunteers 18 years of age or older
Exclusion
- any auto-immune disease or other serious acute, chronic or progressive disease
- hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine.
- history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine.
- within the past 7 days, they have experienced: any acute disease, infections requiring systemic antibiotic or antiviral therapy.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
520 Patients enrolled
Trial Details
Trial ID
NCT00311480
Start Date
March 1 2006
Last Update
March 13 2007
Active Locations (4)
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1
G. D'Annunzio University
Chieti, Italy, 66100
2
Department of Health Sciences
Genoa, Italy, 16129
3
ASL Lanciano-Vasto
Lanciano, Italy, 66034
4
University Hospital of Siena
Siena, Italy, 53100