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.
Study Type
OBSERVATIONAL
Enrollment
66
Collection of blood samples and completion of an electronic Diary (eDiary)
Centre for Vaccinology (CEVAC)
Ghent, Belgium
Proportion of overall subjects reporting Influenza-Like-Illness cases as per Flu-PRO® questionnaire.
Time frame: 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.
Time frame: 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.
Time frame: Through study completion, an average of 8 months.
Severity scores of overall Influenza-Like-Illness cases as per Flu-PRO® questionnaire.
Time frame: Through study completion, an average of 8 months.
Severity scores of Influenza-Like-Illness cases as per Flu-PRO® questionnaire with laboratory-confirmed influenza.
Time frame: 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.
Time frame: Through study completion, an average of 8 months.
Duration of overall Influenza-Like-Illness cases as per Flu-PRO® questionnaire.
Time frame: Through study completion, an average of 8 months.
Duration of Influenza-Like-Illness cases as per Flu-PRO® questionnaire with laboratory-confirmed influenza.
Time frame: Through study completion, an average of 8 months.
Duration of Influenza-Like-Illness cases as per Flu-PRO® questionnaire with non-laboratory-confirmed influenza.
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Time frame: Through study completion, an average of 8 months.
Anti-NP immunoglobulin G (IgG) titers by ELISA at each time point.
Time frame: Through study completion, an average of 8 months.
Symptomatic and asymptomatic flu cases based on the abovementioned variables/parameters.
Time frame: Through study completion, an average of 8 months.