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| Name | Class |
|---|---|
| Quintiles, Inc. | INDUSTRY |
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Immunogenicity and safety of a cell-derived influenza vaccine in adults aged >= 18 and <= 64 years, plus revaccination
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cell-Derived Trivalent Subunit Influenza Vaccine | Biological | surface antigen, inactivated, prepared in cell cultures |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the immunogenicity of the cell-derived subunit vaccine three weeks after vaccination, by applying the FDA requirement for influenza vaccines. | 3 weeks | |
| To assess after the first vaccination the safety and tolerability of the cell-derived subunit vaccine compared to placebo. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the long-term immunogenicity (6 months) of the cell-derived subunit vaccine. | 6 months | |
| To assess the immunogenicity of the cell-derived subunit vaccine three weeks after revaccination. | 3 weeks |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Hanka de Voogd, MD | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 45690 | Jacksonville | Florida | 32216 | United States | ||
| Site Reference ID/Investigator# 45687 |
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| Placebo | Biological | Placebo |
|
| To assess after the second vaccination the safety and tolerability of the cell-derived subunit vaccine. | 6 months |
| Pembroke Pines |
| Florida |
| 33024 |
| United States |
| Site Reference ID/Investigator# 45697 | South Miami | Florida | 33143 | United States |
| Site Reference ID/Investigator# 45691 | Lenexa | Kansas | 66219 | United States |
| Site Reference ID/Investigator# 45689 | Overland Park | Kansas | 66212 | United States |
| Site Reference ID/Investigator# 45694 | Wichita | Kansas | 67207 | United States |
| Site Reference ID/Investigator# 45682 | Lexington | Kentucky | 40509 | United States |
| Site Reference ID/Investigator# 45684 | Kansas City | Missouri | 64114 | United States |
| Site Reference ID/Investigator# 45685 | Omaha | Nebraska | 68134 | United States |
| Site Reference ID/Investigator# 45686 | Las Vegas | Nevada | 89104 | United States |
| Site Reference ID/Investigator# 45688 | Raleigh | North Carolina | 27612 | United States |
| Site Reference ID/Investigator# 45696 | Nashville | Tennessee | 37203 | United States |
| Site Reference ID/Investigator# 45683 | Austin | Texas | 78705 | United States |
| Site Reference ID/Investigator# 45695 | Fort Worth | Texas | 76135 | United States |
| Site Reference ID/Investigator# 45692 | Salt Lake City | Utah | 84124 | United States |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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