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| Name | Class |
|---|---|
| Harmony Clinical Research BVBA | OTHER |
| Inferential | INDUSTRY |
| University Hospital, Ghent | OTHER |
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This prospective epidemiological cohort study is being conducted in order to generate epidemiological data in support of Osivax's clinical development of a broad-spectrum influenza vaccine based upon the internal influenza nucleoprotein (NP), i.e., OVX836.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prospective epidemiological cohort | Urban population of healthy subjects aged 20-64 years, not vaccinated against influenza. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasopharyngeal swabs | Other | Completion of an electronic Diary (eDiary) and collection of nasopharyngeal swabs in case the subject experiences ILI symptoms |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number and percentage of participants reporting ILI episodes (overall, laboratory confirmed or not), during the influenza season and during the whole study. | Through study completion, an average of 6 months. | |
| Number and percentage of participants presenting RT-PCR confirmed influenza A or B cases, during the influenza season and during the whole study. | Through study completion, an average of 6 months. | |
| Number and percentage of participants presenting RT-PCR confirmed SARS-CoV-2 cases, during the influenza season and during the whole study. | Through study completion, an average of 6 months. |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy subjects, men and women aged 20 to 64 years.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Vaccinology (CEVAC) | Ghent | 9000 | Belgium |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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Subjects experiencing influenza-like illness (ILI) symptoms will be asked to contact the investigational center to set up an additional visit within a maximum of 7 days of symptoms onset. During the additional visit, a nasopharyngeal swab will be collected to perform a reverse transcriptase-polymerase chain reaction (RT-PCR) assay to detect influenza A, influenza B, RSV, and/or SARS-CoV-2.
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |