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The study is to assess whether the influenza vaccine Inflexal V for season 2013/2014 fulfills the EMA requirements for re-registration of influenza vaccines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elderly subjects aged over 60 years | Experimental |
| |
| Adults from 18 to 60 years old inclusive | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inflexal V | Biological | Intramuscular administration (M. deltoideus) of a single dose of 0.5 mL Inflexal V |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with seroconversion, seroprotection, and fold increase in geometric mean titer (GMT) | Immunogenicity variables are analyzed according to the EMA re-licensing criteria; at least one of the criteria has to be fulfilled for each vaccine strain:
| Day 22 +/- 2 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of solicited local adverse events | Days 1 to 4 inclusive | |
| Incidence of solicited systemic adverse events | Days 1 to 4 inclusive | |
| Incidence of unsolicited adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Milko Radicioni, MD | Cross Research S.A. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CROSS Research S.A. - Phase I Unit | Arzo | 6864 | Switzerland |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C475022 | Inflexal V |
| D000954 | Antigens, Surface |
| D022701 | Virosomes |
| ID | Term |
|---|---|
| D000941 | Antigens |
| D001685 | Biological Factors |
| D008567 | Membranes, Artificial |
| D001697 | Biomedical and Dental Materials |
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|
| Days 1 to 22 inclusive |
| D012140 | Respiratory Tract Diseases |
| D004337 |
| Drug Carriers |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D040761 | Biomimetic Materials |