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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-024400-98 | EudraCT Number |
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This study will evaluate safety and immunogenicity of a sub-unit Influenza vaccine when administered to adult and elderly subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other | No comparator is administered, only one IM single dose of trivalent subunit inactivated influenza vaccine is administered during the vaccination visit |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Seasonal Influenza Vaccine | Biological | This phase II is performed as a multicenter study in adult and elderly subjects. Enrolled subjects received one single IM dose of trivalent subunit inactivated flu vaccine during the vaccination visit, according to the study protocol (follow-up period: until day 22) . |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the antibody response to each influenza vaccine antigen at 21 days post-immunization in adult and elderly | To evaluate the antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) and/or HI at 21 days post-immunization in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines. | 22 days including follow-up period |
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Inclusion Criteria:
Healthy, adult and elderly volunteers over 18 years
Exclusion Criteria:
Individuals with any serious chronic or acute disease or known or suspected impairment of the immune system.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G. D'Annunzio | Via Dei Vestini | Cheiti | 66100 | Italy | ||
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| Dipartimento di Scienze della Salute Università di Genova |
| Via Pastore |
| Genova |
| 16132 |
| Italy |
| Distretto Sanitario di Base di Fossacesia | Via Polidoro-Vasto | Lanciano | Italy |
| ASL Lanciano - Vasto, | Via S. Spaventa | Lanciano | 66034 | Italy |
| Vaccine and Immunotherapy Research Center Department of Infectious and Tropical Diseases San Raffaele Scientific Institute | Via Stamira d'Ancona | Milano | 20127 | Italy |
| Dipartimento di malattie infettive Ospedale San Gerardo | Via Pergolesi 33 | Monza | 20052 | Italy |
| 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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