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The objective of this study is to assess the safety and immunogenicity of inactivated influenza vaccine (whole virion, Vero cell derived). Subjects will be randomly assigned to receive a single injection of whole virion, Vero cell derived or egg derived influenza vaccine on Day 0. Subjects will return to the study site for safety evaluation at predetermined intervals for 180 days after vaccination. Subjects will also have blood drawn at predetermined intervals to measure their immunologic response to vaccination.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inactivated influenza vaccine (whole virion, Vero cell-derived) | Biological | |||
| Inactivated influenza vaccine (egg derived) [licensed control vaccine] | Biological |
Inclusion Criteria:
Male and female subjects who
Exclusion Criteria:
Subjects who
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| Name | Affiliation | Role |
|---|---|---|
| Markus Müller, MD | Allgemeines Krankenhaus Wien (General Hospital Vienna) | Principal Investigator |
| Kasra Shakeri-Nejad, MD | Klinikum Westend, Berlin | Principal Investigator |
| Bernhard Schmitt, MD | Internistische Gemeinschaftspraxis (Group practice for internal medicine) Dr. Regner & Dr. Schmitt, Mainz | Principal Investigator |
| Alen Jambrecina, MD | MDS Pharma Services Germany GmbH, Hamburg | Principal Investigator |
| Stephan De la Motte, MD | Harrison Clinical Research / Clinical Unit, Munich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allgemeines Krankenhaus Wien (General Hospital Vienna) | Vienna | 1090 | Austria | |||
| Klinikum Westend, Haus 18 |
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| Berlin |
| 14050 |
| Germany |
| Internistische Gemeinschaftspraxis Dr. Regner & Dr. Schmitt (Group practice for internal medicine) | Mainz | 55116 | Germany |
| 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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