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This is a double-blind, placebo controlled, safety and immunogenicity study of GelVac™ nasal powder H5N1 influenza vaccine. Healthy male and female subjects between 18 and 49 years of age who are eligible for study participation will be enrolled in the trial. It is expected that 10 subjects will be screened to obtain 7 subjects who will be eligible for study participation.
The primary objective is to determine the frequency and severity of local and systemic adverse events of vaccine.
The secondary objective is to assess the immunogenicity of the vaccine based on geometric mean titers (GMT) of serum HAI, serum neutralizing, and nasal wash IgA antibodies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| of GelVac™ nasal powder H5N1 influenza vaccine. | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GelVac™ nasal powder H5N1 influenza vaccine. | Drug | subjects will be randomized to either 30 µg of Inactivated H5N1 Influenza Vaccine Administered in GelVac™ Nasal Powder given as two doses of 15 μg in one nostril or placebo vaccine given as two doses administered in GelVac™ Nasal Powder in one nostril |
| Measure | Description | Time Frame |
|---|---|---|
| The primary objective is to determine the frequency of adverse events of the vaccine. | up to 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary objective is to assess the immunogenicity of the vaccine based on geometric mean titers (GMT) of serum HAI. | up to 26 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Research Network, LLC | Gainesville | Florida | 32605 | United States |
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| Placebo | Drug | subjects will be randomized to either 30 µg of Inactivated H5N1 Influenza Vaccine Administered in GelVac™ Nasal Powder given as two doses of 15 μg in one nostril or placebo vaccine given as two doses administered in GelVac™ Nasal Powder in one nostril |
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