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The study will assess the safety, reactogenicity, and tolerability of VAX102 when given with Trivalent Inactivated Influenza Vaccine (TIV) delivered in the same arm as two separate IM injections in healthy adults 18 to 49 years. The investigators will measure the immunogenicity of the VAX102 when given with TIV and the antibody response to TIV when given with VAX102 compared to TIV alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VAX102 | Active Comparator | Simultaneous administration of VAX102 1 ug i.m. plus TIV |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VAX102 | Biological | All subjects receive TIV, one half of the subjects are randomized to receive VAX102 1 ug and one half are randomized to receive placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| Immune response | 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David N Taylor, MD | VaxInnate Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johnson County Clin Trials | Lenexa | Kansas | 66219 | United States | ||
| Vanderbilt Clinical Trials Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21203437 | Derived | Talbot HK, Rock MT, Johnson C, Tussey L, Kavita U, Shanker A, Shaw AR, Taylor DN. Immunopotentiation of trivalent influenza vaccine when given with VAX102, a recombinant influenza M2e vaccine fused to the TLR5 ligand flagellin. PLoS One. 2010 Dec 28;5(12):e14442. doi: 10.1371/journal.pone.0014442. |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C559063 | VAX102 vaccine |
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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|
| Placebo | Biological | All subjects receive TIV, one half of the subjects are randomized to receive VAX102 1 ug and one half are randomized to receive placebo |
|
| Nashville |
| Tennessee |
| 37212 |
| United States |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |