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The present study will evaluate the safety and immunogenicity in healthy people (non-elderly adult and elderly subjects) after one intramuscular (IM) dose of trivalent subunit inactivated flu vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Other | No comparator is administered, only one IM single dose of trivalent subunit inactivated influenza vaccine is administered during the vaccination visit |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trivalent subunit inactivated flu vaccine, Formulation 2010-2011 | Biological | This phase II is performed as a multicenter study site in non-elderly 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: till day 22). |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the antibody response to each influenza vaccine antigen at 21 days post-immunization in non-elderly adult and elderly subjects | 22 days, including the follow-up period |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety of a single IM injection of trivalent subunit inactivated FLU vaccine in non-elderly adult and elderly subjects | 22 days, including the follow-up period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Vaccines | Novartis Vaccines | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G. D'Annunzio, Via dei Vestini | Chieti | 66100 | Italy | |||
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| Dipartimento di Medicina Clinica e Sperimentale - Sezione di Igiene e Medicina Preventiva, Via Fossato di Mortara, 64/b |
| Ferrara |
| 44100 |
| Italy |
| Dipartimento di Scienze della Salute Università di Genova Via Pastore, 1 | Genova | 16132 | Italy |
| Centro Satellite. ASL Lanciano - Vasto, sede legale Via S. Spaventa, 37 | Lanciano | 66034 | Italy |
| Vaccine and Immunotherapy Research Center Department of Infectious and Tropical Diseases San Raffaele Scientific Institute Via Stamira d'Ancona, 20 | Milan | 20127 | Italy |