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| Name | Class |
|---|---|
| Quintiles, Inc. | INDUSTRY |
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A phase 3 study to obtain additional safety and immunogenicity data on Solvay's cell-derived seasonal trivalent subunit influenza vaccine in adult and elderly subjects without significant illnesses and to demonstrate consistency of the immunogenicity of the three lots of the same vaccine, comparison of cell-derived vaccine to Solvay's egg-derived vaccine including assessment of non-inferior immunogenicity
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Experimental |
| |
| 4 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza Vaccine | Biological | surface antigen, inactivated, prepared in cell cultures |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-HA antibody titers and derived parameters seroprotection, seroconversion and fold increase | 3 weeks |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Hanka de Voogd, MD | Abbott Healthcare Products B.V. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 44652 | Adelaide | 5000 | Australia | |||
| Site Reference ID/Investigator# 44662 |
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| Influenza Vaccine |
| Biological |
surface antigen, inactivated, prepared in egg (influvac ®) |
|
| Influenza Vaccine | Biological | surface antigen, inactivated, prepared in cell cultures |
|
| Influenza Vaccine | Biological | surface antigen, inactivated, prepared in cell cultures |
|
| Auchenflower |
| 4066 |
| Australia |
| Site Reference ID/Investigator# 44651 | Blacktown | 2148 | Australia |
| Site Reference ID/Investigator# 44659 | Blacktown | 2148 | Australia |
| Site Reference ID/Investigator# 44647 | Broadmeadow | 2292 | Australia |
| Site Reference ID/Investigator# 44649 | Caboolture | 4510 | Australia |
| Site Reference ID/Investigator# 44646 | Carina Heights | 4152 | Australia |
| Site Reference ID/Investigator# 44650 | Herston | 4006 | Australia |
| Site Reference ID/Investigator# 44663 | Hornsby | 2077 | Australia |
| Site Reference ID/Investigator# 44645 | Kippa-Ring | 4020 | Australia |
| Site Reference ID/Investigator# 44644 | Malvern East | 3145 | Australia |
| Site Reference ID/Investigator# 44648 | Maroubra Junction | 2035 | Australia |
| Site Reference ID/Investigator# 44643 | Sherwood | 4075 | Australia |
| Site Reference ID/Investigator# 44653 | Christchurch | New Zealand |
| Site Reference ID/Investigator# 44658 | Dunedin | 9012 | New Zealand |
| Site Reference ID/Investigator# 44656 | Grafton | 1150 | New Zealand |
| Site Reference ID/Investigator# 44655 | Rotorua | 3010 | New Zealand |
| Site Reference ID/Investigator# 44654 | Tauranga | 3110 | New Zealand |
| Site Reference ID/Investigator# 44657 | Wellington | 6035 | New Zealand |
| 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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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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