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| Name | Class |
|---|---|
| University 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) as a target for immune response.
The present 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) as a target for immune response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prospective epidemiological cohort | Urban and suburban population of healthy subjects aged 18-55 years, not vaccinated against influenza |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood samples | Other | Collection of blood samples and completion of an electronic Diary (eDiary) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of overall subjects reporting Influenza-Like-Illness cases as per Flu-PRO® questionnaire. | Through study completion, an average of 8 months. | |
| Proportion of subjects reporting Influenza-Like-Illness cases as per Flu-PRO® questionnaire with laboratory-confirmed influenza. | Through study completion, an average of 8 months. | |
| Proportion of subjects reporting Influenza-Like-Illness cases as per Flu-PRO® questionnaire with non-laboratory-confirmed influenza. | Through study completion, an average of 8 months. | |
| Severity scores of overall Influenza-Like-Illness cases as per Flu-PRO® questionnaire. | Through study completion, an average of 8 months. | |
| Severity scores of Influenza-Like-Illness cases as per Flu-PRO® questionnaire with laboratory-confirmed influenza. | Through study completion, an average of 8 months. | |
| Severity scores of Influenza-Like-Illness cases as per Flu-PRO® questionnaire with non-laboratory-confirmed influenza. | Through study completion, an average of 8 months. | |
| Duration of overall Influenza-Like-Illness cases as per Flu-PRO® questionnaire. | Through study completion, an average of 8 months. | |
| Duration of Influenza-Like-Illness cases as per Flu-PRO® questionnaire with laboratory-confirmed influenza. | Through study completion, an average of 8 months. | |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy subjects, men and women aged 18 to 55 years.
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| Name | Affiliation | Role |
|---|---|---|
| Isabel Leroux-Roels, MD, PhD | Centre for Vaccinology (CEVAC), Ghent University Hospital | Principal Investigator |
| 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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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Serum samples (total volume approximately 10 mL of whole blood per visit) obtained at study entry (before onset of the influenza season) and 6 months after, upon completion of the influenza season, will serve as alternative method for case confirmation and detection of unrecognized or asymptomatic infections.
| Duration of Influenza-Like-Illness cases as per Flu-PRO® questionnaire with non-laboratory-confirmed influenza. |
| Through study completion, an average of 8 months. |
| Anti-NP immunoglobulin G (IgG) titers by ELISA at each time point. | Through study completion, an average of 8 months. |
| Symptomatic and asymptomatic flu cases based on the abovementioned variables/parameters. | Through study completion, an average of 8 months. |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |