The objective of this study is to evaluate the safety of the vaccine and the immune response to the vaccine in healthy adult volunteers 65 years of age or older. Volunteers will be assigned by randomization to receive either the vaccine or an inactive substance (placebo) by injections in the arm on two occasions over one month. The study will last approximately 10 months and will have a total of 7 visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
28
Johnson County Clin-Trials
Lenexa, Kansas, United States
Evaluate the safety of AVX502 in healthy adult volunteers 65 years of age or older via the frequency of systemic reactogenicity events, local vaccine reactions and Adverse Events
Time frame: 28 weeks
Evaluate the immunogenicity of AVX502 in healthy adult volunteers 65 years of age and older via serum antibody concentration
Time frame: 4 weeks after second dose of vaccine
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2 doses of placebo given at T=0 and T=4 weeks via the SC route