A Prospective Epidemiological Study Evaluating Occurrences of Influenza-like Illness (NCT06779981) | Clinical Trial Compass
CompletedNot Applicable
A Prospective Epidemiological Study Evaluating Occurrences of Influenza-like Illness
Belgium119 participantsStarted 2024-12-13
Plain-language summary
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.
Who can participate
Age range20 Years – 64 Years
SexALL
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Inclusion criteria
✓. Written informed consent.
✓. Healthy male or female participants, as determined by medical history and medical examination (as needed).
✓. Between the ages of 20 and 64 years, inclusive.
✓. Reliable and willing to make themselves available for the duration of the study, and willing and able to follow study procedures.
✓. Ability and technical possibility for completing an eDiary.
Exclusion criteria
✕. Subjects with a body mass index (BMI) ≤18 kg/m² or ≥35 kg/m²
✕. Previous influenza vaccination within 6 months before the day of enrollment or planned to receive during the study duration.
✕. Previous vaccination with an mRNA-based influenza vaccine including NP in its composition.
✕. Previous administration of OVX836.
✕. Pregnant or lactating woman.
✕. Females planning to become pregnant or planning to discontinue contraceptive precautions until the end of the trial. Women of childbearing potential (WOCBP) should have appropriate contraceptive methods in place for 2 months before enrolment. Appropriate contraceptive methods are to be maintained until the end of the trial. Please also refer to Appendix A.
✕. Past or current history of significant autoimmune diseases, as judged by the Investigator.
What they're measuring
1
Number and percentage of participants reporting ILI episodes (overall, laboratory confirmed or not), during the influenza season and during the whole study.
Timeframe: Through study completion, an average of 6 months.
2
Number and percentage of participants presenting RT-PCR confirmed influenza A or B cases, during the influenza season and during the whole study.
Timeframe: Through study completion, an average of 6 months.
3
Number and percentage of participants presenting RT-PCR confirmed SARS-CoV-2 cases, during the influenza season and during the whole study.
Timeframe: Through study completion, an average of 6 months.