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 range

20 Years – 64 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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.

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.

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.

Trial details

NCT IDNCT06779981

SponsorOsivax

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-06-19

View on ClinicalTrials.gov More Influenza trials

Who can participate

Age range

20 Years – 64 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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.

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.

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.