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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Nasal Aerosol Immunization | Placebo Comparator |
| |
| Nasal Droplet Immunization | Placebo Comparator |
| |
| Intramuscular Immunization | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluzone | Drug | 0.5 ml/15 micrograms |
| |
| Fluzone |
| Measure | Description | Time Frame |
|---|---|---|
| Change in hemagglutinin antibody titers from baseline to Day 28 in serum and mucosal secretions. | Assessments will include hemagglutination inhibition and antibody isotypes determination. | Baseline to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events. | Baseline to Day 28 | |
| Comparison of hemagglutinin antibody titers between intranasal and intramuscular route of administration, from baseline to Day 28. | Baseline to Day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Sundy, MD, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Drug |
0.5 ml/60 micrograms |
|