CompletedPhase 2

Safety and Immunogenicity of Two Dose Levels of OVX836 Influenza Vaccine as a Booster on Participants Previously Administered With OVX836

Belgium117 participantsStarted 2024-10-22

Plain-language summary

This phase 2a is designed to evaluate the anamnestic response of a booster dose (either 180 µg or 480 µg) of OVX836 influenza vaccine administered intramuscularly to participants vaccinated three to five years ago in OVX836-002 or OVX836-003 studies. Participants who had received a placebo or Influvac Tetra® in previous studies would serve as controls and would receive the highest dose of OVX836 vaccine (480 µg) as a primary vaccination.

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

. Subject who voluntarily provides written informed consent to participate in the study.
. Healthy male or female subjects, as determined by medical history and medical examination
. Subject compliant with the reproductive criteria for female participants
. Subjects who participated in the OVX836-002 or OVX836-003 studies.
. Subjects aged 20 and 64 years, inclusive.
. Reliable and willing to commit to participating for the duration of the study, and capable of following study procedures diligently.
. Ability and technical capability to complete an eDiary.

Exclusion criteria

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

Safety evaluation of OVX836 (180µg and 480µg)

Timeframe: From enrollment to the end of trial at 180 days.

Trial details

NCT IDNCT06582277

SponsorOsivax

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-06-02

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