Status:
COMPLETED
Safety and Immunogenicity of Two Adjuvanted and One Non-adjuvanted H5N1 Influenza Vaccine in Adults
Lead Sponsor:
Novartis Vaccines
Conditions:
Influenza
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
The present study aims to evaluate safety and immunogenicity of two doses, administered three weeks apart, and a 6 month booster dose, of two influenza vaccines containing 7.5 micrograms or 15 microgr...
Eligibility Criteria
Inclusion
- Male and female volunteers 18-60 years of age
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 or infections requiring systemic antibiotic or antiviral therapy
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00382187
Start Date
November 1 2006
End Date
January 1 2008
Last Update
December 1 2016
Active Locations (1)
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1
Presidio Distrettuale N. 8, Azienda USL 7 di Siena, Via Savina Petrilli, 3
Siena, Siena, Italy, 53100