Safety and Immunogenicity of MF59C.1 Adjuvanted Trivalent Subunit Influenza Vaccine in Elderly Subjects
| Status: | Archived |
|---|---|
| Conditions: | Influenza |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | August 2010 |
| End Date: | December 2011 |
A Phase III, Randomized, Controlled, Observer-Blind, Multicenter Study to Evaluate the Safety and Immunogenicity and the Consistency of Three Consecutive Lots of a MF59C.1 Adjuvanted Trivalent Subunit Influenza Vaccine in Elderly Subjects Aged 65 Years and Older
The present phase III study aims to evaluate the safety and immunogenicity of
MF59-adjuvanted subunit seasonal influenza vaccine and to evaluate the consistency in the
manufacturing process of three consecutive lots of MF59-adjuvanted subunit seasonal
influenza vaccine with respect to immunogenicity in subjects aged 65 years and older. The
active comparator non-adjuvanted seasonal influenza vaccine is approved for use in this age
group in the United States and will be used to provide a comparative assessment for
immunogenicity and safety.
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