Efficacy, Immunogenicity and Safety of OVX836 Influenza Vaccine 480μg
NCT ID: NCT05569239
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE2
2850 participants
INTERVENTIONAL
2025-09-08
2026-05-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
OVX836 480µg
Adjuvant-free recombinant influenza candidate vaccine based on Nucleoprotein in the influenza virus. One single administration intramuscularly of 480µg dose on Day1.
OVX836 480µg
One single administration intramuscularly at Day 1.
Placebo
Saline solution (B. Braun Ecoflac Plus) Saline solution (Nacl 0.9%), B. Braun Ecoflac Plus 50mL. One single administration intramuscularly of a 0.8mL dose on Day1.
Saline Solution
One single administration intramuscularly at Day 1.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
OVX836 480µg
One single administration intramuscularly at Day 1.
Saline Solution
One single administration intramuscularly at Day 1.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Healthy male or female subjects, as determined by medical history and medical examination.
3. Between the ages of 18 and 59 years, inclusive.
4. 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.
5. Subjects compliant with the reproductive criteria for male and female participants .
6. Reliable and willing to make themselves available for the duration of the study, and willing and able to follow study procedures
7. Able to read, understand and complete an electronic Diary and electronic Patient Reported Outcome.
8. Able to read and sign the subject information sheet and informed consent form (ICF).
Exclusion Criteria
2. 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.
3. Any known or suspected immunodeficient conditions.
4. Past or current history of significant autoimmune diseases, as judged by the Investigator.
5. Known or suspected infection with human immunodeficiency virus, hepatitis C virus, or hepatitis B virus.
6. Current history of significant uncontrolled medical illness such as diabetes, hypertension, heart, renal or hepatic diseases, as judged by the Investigator.
7. Planned absences without access to the investigational site, i.e. vacation or business trips, for more than 7 consecutive days during the study period
8. Pregnant or lactating woman.
9. Females planning to become pregnant or planning to discontinue contraceptive precautions until the end of the trial.
10. Having received another vaccine within 1 month prior to the day of study vaccination, except COVID-19 vaccines for which the minimum time period should be two weeks prior to study vaccination.
11. Having participated or currently participating in an OVX836 study or in the OVX-FLU-002 study.
12. Planning to receive any other vaccines during the first 28 days following the study vaccine administration, except COVID-19 vaccines which can be administered from 14 days following the study vaccine administration.
13. Administration of any investigational or non-registered drug or vaccine within 1 months prior to the administration of study vaccines, or planned administration of any such product during the whole study period.
14. History of receiving blood, blood components or immunoglobulins within 3 months prior to the day of vaccination, or planned to receive such product during the whole study period.
15. Presence of an acute febrile illness on the day of planned vaccination (oral temperature \>38.0°C; temporary exclusion criterion).
16Diagnosed long COVID-19 subjects. 17. Presence of a condition in the ear-nose-throat area, such as nasal septum deviation, atrophic rhinitis, etc…, that could render nasal and nasopharyngeal swabs more difficult to perform, or increase the risk of bleeding; to be confirmed by medical history question and inspection of nasal passage.
18\. Past or current history of any progressive or severe uncontrolled neurological disorder, seizure disorder or Guillain-Barré syndrome.
19\. 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.
20\. Past (stopped less than 6 months before enrolment) or current smoking habit above 10 cigarettes per day.
21\. Past (stopped less than 6 months before enrolment) or current history of heavy alcohol use, defined as follows: for men, consumption of more than 4 standard drinks on any day or more than 14 standard drinks per week, and for women, consumption of more than 3 standard drinks on any day or more than 7 standard drinks per week.
22\. Past (stopped less than 6 months before enrolment) or current use of recreational drugs, which could interfere with the adherence to the protocol procedures.
23\. Chronic or prolonged treatment (\>10 consecutive days) that can affect immune response, such as systemic (≥ 20 mg/day prednisone or equivalent or dexamethasone \>4 mg/day), high dose inhaled corticosteroids (\>800 μg/day beclomethasone or equivalent; occasional inhaled, topical or localized injections \[intra-articular or intra-bursal\] of corticosteroids for asthma therapy are allowed), or immunomodulators/suppressors (certain monoclonal antibodies can be approved on a case by case basis) within 28 days before study entry or during the whole study duration.
24\. Chronic or prolonged (\>10 days) use of systemic non-steroidal anti-inflammatory drugs, acetylsalicylic acid, or paracetamol within 7 days before study entry and up to 28 days post-vaccination.
25\. Prophylactic or therapeutic use of influenza antivirals within 7 days prior to the day of study vaccination or during the whole study duration.
26\. History of severe allergic reactions and/or anaphylaxis, or serious adverse reactions to vaccines or allergy to kanamycin or any other component of the OVX836 vaccine.
27\. Any contraindication to intramuscular administration, as judged by the Investigator.
28\. Presence of extended tattoos on both deltoid muscles. 29. Individuals with history of any illness that, in the opinion of the Investigator, might interfere with the results of the study, or pose additional risk to the subjects due to participation in the study, either directly or through any treatments administered for that illness.
30\. Sponsor employees or Investigator site personnel directly affiliated with this study, and their immediate families. Immediate family is defined as a spouse (or assimilated), parent, child or sibling, whether biological or legally adopted.
18 Years
59 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Osivax
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Site BE-02
Antwerp, , Belgium
Site BE-03
Antwerp, , Belgium
Site BE-01
Ghent, , Belgium
Site BE-04
Mechelen, , Belgium
Site FI-12
Espoo, , Finland
Site FI-08
Helsinki, , Finland
Site FI-13
Järvenpää, , Finland
FI-14
Kokkola, , Finland
Site FI-11
Oulu, , Finland
Site FI-15
Seinäjoki, , Finland
Site FI-09
Tampere, , Finland
Site FI-10
Turku, , Finland
Site FR-05
Lyon, , France
Site FR-07
Paris, , France
Site FR-06
Rennes, , France
Site DE-16
München, , Germany
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
OVX836-005
Identifier Type: -
Identifier Source: org_study_id