Active — Not RecruitingPhase 2

Efficacy, Immunogenicity and Safety of OVX836 Influenza Vaccine 480μg

Belgium, Finland2,850 participantsStarted 2025-09-08

Plain-language summary

The present study will evaluate the efficacy, immunogenicity and safety of one dose of OVX836 influenza vaccine 480μg, after intramuscular administration in healthy subjects aged 18-59 years.

Who can participate

Age range18 Years – 59 Years

SexALL

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Inclusion criteria

✓. Written informed consent
✓. Healthy male or female subjects, as determined by medical history and medical examination.
✓. Between the ages of 18 and 59 years, inclusive.
✓. Subject socially active: living in a family with children or with other house-hold members, having frequent social contacts at university, work, in public places such as restaurants, theaters, public transportation, etc.
✓. Subjects compliant with the reproductive criteria for male and female participants .
✓. Reliable and willing to make themselves available for the duration of the study, and willing and able to follow study procedures
✓. Able to read, understand and complete an electronic Diary and electronic Patient Reported Outcome.
✓. Able to read and sign the subject information sheet and informed consent form (ICF).

Exclusion criteria

✕. Previous vaccination with an authorized or experimental seasonal, zoonotic or pandemic influenza vaccine within 6 months before the day of vaccination or planned to receive it during the whole study period.
✕. Formal indication for influenza vaccination on an individual basis according to local recommendations, for example based on occupational risk, or underlying medical conditions. An informed subject who would refuse to get the regular influenza vaccination would be allowed to participate in this study.
✕. Any known or suspected immunodeficient conditions.
✕. Past or current history of significant autoimmune diseases, as judged by the Investigator.
✕. Known or suspected infection with human immunodeficiency virus, hepatitis C virus, or hepatitis B virus.
✕. Current history of significant uncontrolled medical illness such as diabetes, hypertension, heart, renal or hepatic diseases, as judged by the Investigator.
✕. Planned absences without access to the investigational site, i.e. vacation or business trips, for more than 7 consecutive days during the study period
✕. Pregnant or lactating woman.

What they're measuring

First occurrence of RT-PCR-confirmed influenza Type A symptomatic disease

Timeframe: During the whole study duration, up to maximum 10 months

Trial details

NCT IDNCT05569239

SponsorOsivax

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-05-29

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