The purpose of this study is to determine the safety and effectiveness of the influenza vaccine when administered nasally and intra-muscular (a "shot" of medicine given into a muscle). The investigators will measure the systemic (through out the body) and mucosal immune responses (how your body recognizes and defends itself against bacteria) to nasally administered influenza vaccine, and determine if nasal immunization results in immunity (your body's ability to avoid infections) within multiple mucosal compartments (ocular (eye), oral and reproductive), in comparison with intramuscular administration and placebo (inactive substance given in the same form as the active drug).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
60
0.5 ml/15 micrograms
0.5 ml/60 micrograms
Duke University Medical Center
Durham, North Carolina, United States
Change in hemagglutinin antibody titers from baseline to Day 28 in serum and mucosal secretions.
Assessments will include hemagglutination inhibition and antibody isotypes determination.
Time frame: Baseline to Day 28
Number of subjects with adverse events.
Time frame: Baseline to Day 28
Comparison of hemagglutinin antibody titers between intranasal and intramuscular route of administration, from baseline to Day 28.
Time frame: Baseline to Day 28
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