Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose | Experimental |
| |
| High dose | Experimental | Investigational Influenza VLP Vaccine 60ug/strain |
|
| TIV | Active Comparator | Trivalent Influenza Vaccine 15ug/strain, Commercially Licenced |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza VLP Vaccine | Biological | Single dose; 0.5mL |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (AEs) | 0-21 days | |
| Immunogenicity by HAI | 21 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity by HAI compared to commercially licensed TIV vaccine | 21 days | |
| Immunogenicity Against drifted strains by HAI | 21 days | |
| Immunogenicity by neuraminidase activity inhibition (NAI) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universtity Clinical Research | Pembroke Pines | Florida | 33024 | United States | ||
| Mayo Clinic |
Not provided
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| TIV |
| Biological |
Trivalent Influenza Vaccine 15ug/strain, commercially licensed |
|
| 21 Days |
| Rochester |
| Minnesota |
| 55905 |
| United States |
| Brown University | Providence | Rhode Island | 02908 | United States |
| Coastal Carolina Research Center | Mt. Pleasant | South Carolina | 29464 | United States |
| Research Across America | Dallas | Texas | 75234 | United States |
| Clinical Trials of Texas, Inc. | San Antonio | Texas | 78229 | United States |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |