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This is a Phase I/IIa randomized, double-blind, placebo-controlled study to evaluate the safety, reactogenicity, and immunogenicity of 3 potencies (dosages) of H5N1 VLP vaccine or placebo in healthy adults 18 to 40 years of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose H5N1 VLP Vaccine | Experimental |
| |
| Mid dose H5N1 VLP Vaccine | Experimental |
| |
| High dose H5N1 VLP Vaccine | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| H5N1 VLP Vaccine | Biological | Two doses - Day 0 & Day 28 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and reactogenicity of H5N1 VLP Vaccine | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity of H5N1 VLP Influenza vaccine | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George Atiee, M.D. | Healthcare Discoveries, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Healthcare Discoveries, Inc. | San Antonio | Texas | 78209 | United States |
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| Placebo | Biological | Two doses - Day 0 & Day 28 |
|