InfluenzaNCT06779981
A Prospective Epidemiological Study Evaluating Occurrences of Influenza-like Illness
An observational study of Influenza, run by Osivax at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Nasopharyngeal swabs
- Type of treatment
- Vaccines
- How many people
- 119 participants
- Where
- 1 siteBelgium
- Study dates
- 13 Dec 2024to 19 Jun 2025
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy subjects, men and women aged 20 to 64 years.
Who may be able to join
- 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.
Who cannot join
- 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.
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- Past or current history of significant autoimmune diseases, as judged by the Investigator.
- Current history of uncontrolled medical illness such as diabetes, hypertension, heart, renal or hepatic diseases.
- Known or suspected infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV).
- Planned administration of any investigational or non-registered product during the entire study period.
- History of receiving blood, blood components, or immunoglobulins within 3 months prior to the first study visit or planned to receive such product during the whole study period.
- Behavioral or cognitive impairment, or psychiatric disease that, in the opinion of the Investigator, may interfere with the subject's ability to participate in the study.
- History of alcohol or drug abuse that ceased less than 6 months before enrolment, current alcohol or drug abuse according to the Investigator's judgement), smoking habit of more than 10 cigarettes/day, or current vaping (nicotine consumption corresponding to more than 10 cigarettes/day).
- Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months before the study vaccine administration. For corticosteroids, this will mean prednisone equivalent ≥20 mg/day. Inhaled, topical and intra-articular steroids are allowed.
- Individuals with a history of any illness that, in the opinion of the Investigator, could potentially interfere with the results of the study or pose additional risk to the subjects by participating in the study.
- Sponsor employees or Investigator site personnel directly affiliated with this study and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted, including children of newly composed families.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Epidemiological Cohort Study Evaluating Occurrences of Influenza-like Illness in an Urban Population of Healthy Subjects Aged 20-64 Years, Not Vaccinated Against Influenza.
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.
- Conditions
- Influenza
- Being tested
- Nasopharyngeal swabs
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasopharyngeal swabsOther
Also called eDiary
Completion of an electronic Diary (eDiary) and collection of nasopharyngeal swabs in case the subject experiences ILI symptoms
| Study group | Role | What they receive |
|---|---|---|
| Prospective epidemiological cohort | Urban population of healthy subjects aged 20-64 years, not vaccinated against influenza. Receives: Other: Nasopharyngeal swabs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and percentage of participants reporting ILI episodes (overall, laboratory confirmed or not), during the influenza season and during the whole study.
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start13 Dec 2024
- Primary completion19 Jun 2025
- Study completion19 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 119 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Osivax
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Harmony Clinical Research BVBA, Inferential, University Hospital, Ghent
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06779981
- Sponsor's protocol ID
- OVX-FLU-002
- Status last verified
- Jun 2025
- First submitted
- 14 Jan 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Epidemiological Cohort Study Evaluating Occurrences of Influenza-like Illness in an Urban Population of Healthy Subjects Aged 20-64 Years, Not Vaccinated Against Influenza.
- ClinicalTrials.gov ID
- NCT06779981
- Acronym / sponsor ID
- OVX-FLU-002
- Conditions
- Influenza
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- OsivaxIndustry (pharma, biotech, devices)
- Collaborators
- Harmony Clinical Research BVBA, Inferential, University Hospital, Ghent
- Study start
- 13 Dec 2024 (actual)
- Primary completion
- 19 Jun 2025 (actual)
- Study completion
- 19 Jun 2025 (actual)
- First posted
- 17 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective epidemiological cohort | – | Other: Nasopharyngeal swabsUrban population of healthy subjects aged 20-64 years, not vaccinated against influenza. |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy subjects, men and women aged 20 to 64 years.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasopharyngeal swabsAlso: eDiaryCompletion of an electronic Diary (eDiary) and collection of nasopharyngeal swabs in case the subject experiences ILI symptoms | Other | Prospective epidemiological cohort |
Primary outcome
Number and percentage of participants reporting ILI episodes (overall, laboratory confirmed or not), during the influenza season and during the whole study.
Time frame: 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.
Time frame: 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.
Time frame: Through study completion, an average of 6 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza, run by Osivax at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and percentage of participants reporting ILI episodes (overall, laboratory confirmed or not), during the influenza season and during the whole study. (time frame: Through study completion, an average of 6 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.