Safety and Immunogenicity of Two Adjuvanted and One Non-adjuvanted H5N1 Influenza Vaccine in Adults
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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 micrograms of H5N1 influenza antigen, and of a non-adjuvanted influenza vaccine containing 15 micrograms of H5N1 influenza antigen, in adults
A Phase II, Randomized, Controlled, Observer-blind, Single-Center Study to Evaluate Safety and Immunogenicity of Two Doses, Administered Three Weeks Apart, and a Six Month Booster Dose of Two Surface Antigen Adjuvanted With MF59C.1 Influenza Vaccines Containing 7.5 Micrograms or 15 Micrograms of A/H5N1 Influenza Antigen and of a Non-adjuvanted Influenza Vaccine Containing 15 Micrograms of A/H5N1 Influenza Antigen, in Adults
Study Start Date
Actual Primary Completion Date
Actual Study Completion Date
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Ages Eligible for Study:
18 Years to 60 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Male and female volunteers 18-60 years of age
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