A Prospective Epidemiological Study Evaluating Occurrences of Influenza-like Illness

NCT06779981 | Completed

• 1 other identifier: OVX-FLU-002
• Study Type: observational
• Target: 119
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Influenza

Outcome Measures

Primary Outcomes (3)

• Number and percentage of participants reporting ILI episodes (overall, laboratory confirmed or not), during the influenza season and during the whole study.

  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.

  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.

  Through study completion, an average of 6 months.

Study Arms (1)

Prospective epidemiological cohort

Urban population of healthy subjects aged 20-64 years, not vaccinated against influenza.

Other: Nasopharyngeal swabs

Interventions

Nasopharyngeal swabs OTHER

Completion of an electronic Diary (eDiary) and collection of nasopharyngeal swabs in case the subject experiences ILI symptoms

Also known as: eDiary

Prospective epidemiological cohort

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy subjects, men and women aged 20 to 64 years.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Osivax: lead
• Harmony Clinical Research BVBA: collaborator
• Inferential: collaborator
• University Hospital, Ghent: collaborator

Study Sites (1)

Centre for Vaccinology (CEVAC)

Ghent, 9000, Belgium

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Subjects experiencing influenza-like illness (ILI) symptoms will be asked to contact the investigational center to set up an additional visit within a maximum of 7 days of symptoms onset. During the additional visit, a nasopharyngeal swab will be collected to perform a reverse transcriptase-polymerase chain reaction (RT-PCR) assay to detect influenza A, influenza B, RSV, and/or SARS-CoV-2.

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: January 17, 2025
• Study Start: December 13, 2024
• Primary Completion: June 19, 2025
• Study Completion: June 19, 2025
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)