InfluenzaPhase 2NCT05569239
Efficacy, Immunogenicity and Safety of OVX836 Influenza Vaccine 480μg
A Phase 2 study testing OVX836 480µg and Saline Solution in people with Influenza, run by Osivax at 16 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- OVX836 480µg and Saline Solution
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,891 participants
- Where
- 16 sitesin 4 countries
- Study dates
- 8 Sep 2025to 18 May 2026
- Phase
- Phase 2
- 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 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 28Show fewer
- 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.
- Females planning to become pregnant or planning to discontinue contraceptive precautions until the end of the trial.
- 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.
- Having participated or currently participating in an OVX836 study or in the OVX-FLU-002 study.
- 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.
- 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.
- 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.
- 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.
Trial locations and contacts
16 sites in 4 countries.
16 sites in 4 countries
Finland8 sites
Site FI-12
Espoo
Site FI-08
Helsinki
Site FI-13
Jarvenpaa
FI-14
Kokkola
Site FI-11
Oulu
Site FI-15
Seinäjoki
Site FI-09
Tampere
Site FI-10
Turku
Belgium4 sites
Site BE-02
Antwerp
Site BE-03
Antwerp
Site BE-01
Ghent
Site BE-04
Mechelen
About this study
Official title: Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Immunogenicity and Safety of One Dose of OVX836 Influenza Vaccine 480μg, After Intramuscular Administration in Healthy Subjects Aged 18-59 Years
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.
Read the detailed description
This Phase 2b proof-of-concept field efficacy study is designed as a randomized, double-blind, parallel groups, placebo-controlled, multi-country, multicenter clinical trial. This design of prospective interventional trial is the gold standard in evaluating absolute efficacy of a product in preventing a disease or an outcome. An adequate number of observations is ensured by the multicenter approach.
- Conditions
- Influenza
- Being tested
- OVX836 480µg, Saline Solution
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OVX836 480µgBiological
One single administration intramuscularly at Day 1.
Saline SolutionBiological
One single administration intramuscularly at Day 1.
| Study group | Role | What they receive |
|---|---|---|
| OVX836 480µg | Experimental | Adjuvant-free recombinant influenza candidate vaccine based on Nucleoprotein in the influenza virus. One single administration intramuscularly of 480µg dose on Day1. Receives: Biological: OVX836 480µg |
| Placebo | Placebo comparator | 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. Receives: Biological: Saline Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
First occurrence of RT-PCR-confirmed influenza Type A symptomatic disease
Measured: During the whole study duration, up to maximum 10 months
Secondary outcomes (16)
First occurrence of RT-PCR-confirmed influenza symptomatic disease irrespective of strain/type.
Measured: During the whole study duration, up to maximum 10 months.
First of occurrence of RT-PCR-confirmed influenza Type B symptomatic disease
Measured: During the whole study duration, up to maximum 10 months
Number of subtype of virus in RT-PCR-confirmed influenza Type A cases.
Measured: During the whole study duration, up to maximum 10 months
Severity and duration of Influenza Like Illness episodes
Measured: During the whole study duration, up to maximum 10 months
First occurence of clinical influenza-like disease irrespective of causal agent
Measured: During the whole study duration, up to maximum 10 months
Number of occurence of solicited local and systemic signs and symptoms
Measured: During 7 days after vaccine administration
Number of occurence of subjects reporting unsolicited AEs
Measured: During 29 days after vaccine administration
Number of occurence of subjects reporting Serious Adverse Events, Adverse Events of Special Interest, New Onset of Chronic Disease, Medical Attended Adverse Events
Measured: During the whole study period, maximum 10 months
Cell-mediated immune response in Peripheral Blood Mononuclear Cells, measured by Interferon Gamma Enzyme-Linked Immunospot Assay in a limited subset of 56 subjects.
Elispot
Measured: At Day 1 and Day 8
Number and percentage of subjects with NP-specific T-cell measured by Interferon Gamma Enzyme-Linked Immunospot Assay.
Elispot
Measured: At Day 1 and Day 8
Percentage of NP specific CD4+ and CD8+ T-cell measured by flow cytometry on PBMCs as expressing IL-2, TNFα and/or IFNγ at pre-injection baseline (Day 1)
ICS
Measured: At Day 1 and Day 8
Number and percentage of subjects with a percentage of NP specific CD4+ and CD8+ T-cell expressing IL-2, TNFα and/or IFNγ at Day 8 or Day 29 higher than the percentile 95 of the pre-injection baseline (Day 1)
ICS
Measured: At Day 1 and Day 8
Geometric Mean Titer of anti-Nucleoprotein immunoglobulin G (Enzyme-Linked Immunosorbent Assay, serum).
Elisa
Measured: At Day 1 and Day 8
Number and percentage of subjects with a four-fold increase of anti-Nucleoprotein immunoglobulin G (Enzyme-Linked Immunosorbent Assay, serum) titre with respect to pre-injection baseline (Day 1)
Elisa
Measured: At Day 1 and Day 8
Percentage of NP specific CD4+ and CD8+ T-cell measured by flow cytometry on PBMCs as expressing IL-2, TNFα and/or IFNγ in a limited subset of 56 subjects
ICS
Measured: At Day 1 and Day 8
Anti-Nucleoprotein immunoglobulin G measured by Enzyme-Linked Immunosorbent Assay in, serum in a limited subset of 56 subjects.
Elisa
Measured: At Day 1 and Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start8 Sep 2025
- Primary completion18 May 2026
- Study completion18 May 2026
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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total number of 2,850 subjects are planned to be randomized (in a 1:1 ratio) into 2 groups to receive a single intramuscular injection of either OVX836 (480μg) or placebo.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2,891 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osivax
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05569239
- Sponsor's protocol ID
- OVX836-005
- Status last verified
- Oct 2026
- First submitted
- 3 Oct 2022
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Immunogenicity and Safety of One Dose of OVX836 Influenza Vaccine 480μg, After Intramuscular Administration in Healthy Subjects Aged 18-59 Years
- ClinicalTrials.gov ID
- NCT05569239
- Acronym / sponsor ID
- OVX836-005
- Conditions
- Influenza
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,891 participants (actual)
- Lead sponsor
- OsivaxIndustry (pharma, biotech, devices)
- Study start
- 8 Sep 2025 (actual)
- Primary completion
- 18 May 2026 (actual)
- Study completion
- 18 May 2026 (actual)
- First posted
- 6 Oct 2022 (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.
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.
Detailed description
This Phase 2b proof-of-concept field efficacy study is designed as a randomized, double-blind, parallel groups, placebo-controlled, multi-country, multicenter clinical trial. This design of prospective interventional trial is the gold standard in evaluating absolute efficacy of a product in preventing a disease or an outcome. An adequate number of observations is ensured by the multicenter approach.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A total number of 2,850 subjects are planned to be randomized (in a 1:1 ratio) into 2 groups to receive a single intramuscular injection of either OVX836 (480μg) or placebo.
| Arm | Type | Receives |
|---|---|---|
| OVX836 480µg | Experimental | Biological: OVX836 480µgAdjuvant-free recombinant influenza candidate vaccine based on Nucleoprotein in the influenza virus. One single administration intramuscularly of 480µg dose on Day1. |
| Placebo | Placebo comparator | Biological: Saline SolutionSaline 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. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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 .
Key exclusion criteria (28 listed)
- 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.
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 |
|---|---|---|
| OVX836 480µgOne single administration intramuscularly at Day 1. | Biological | OVX836 480µg |
| Saline SolutionOne single administration intramuscularly at Day 1. | Biological | Placebo |
Primary outcome
First occurrence of RT-PCR-confirmed influenza Type A symptomatic disease
Time frame: During the whole study duration, up to maximum 10 months
16 secondary outcomes
First occurrence of RT-PCR-confirmed influenza symptomatic disease irrespective of strain/type.
Time frame: During the whole study duration, up to maximum 10 months.
First of occurrence of RT-PCR-confirmed influenza Type B symptomatic disease
Time frame: During the whole study duration, up to maximum 10 months
Number of subtype of virus in RT-PCR-confirmed influenza Type A cases.
Time frame: During the whole study duration, up to maximum 10 months
Severity and duration of Influenza Like Illness episodes
Time frame: During the whole study duration, up to maximum 10 months
First occurence of clinical influenza-like disease irrespective of causal agent
Time frame: During the whole study duration, up to maximum 10 months
Number of occurence of solicited local and systemic signs and symptoms
Time frame: During 7 days after vaccine administration
Number of occurence of subjects reporting unsolicited AEs
Time frame: During 29 days after vaccine administration
Number of occurence of subjects reporting Serious Adverse Events, Adverse Events of Special Interest, New Onset of Chronic Disease, Medical Attended Adverse Events
Time frame: During the whole study period, maximum 10 months
Cell-mediated immune response in Peripheral Blood Mononuclear Cells, measured by Interferon Gamma Enzyme-Linked Immunospot Assay in a limited subset of 56 subjects.
Time frame: At Day 1 and Day 8
Number and percentage of subjects with NP-specific T-cell measured by Interferon Gamma Enzyme-Linked Immunospot Assay.
Time frame: At Day 1 and Day 8
Percentage of NP specific CD4+ and CD8+ T-cell measured by flow cytometry on PBMCs as expressing IL-2, TNFα and/or IFNγ at pre-injection baseline (Day 1)
Time frame: At Day 1 and Day 8
Number and percentage of subjects with a percentage of NP specific CD4+ and CD8+ T-cell expressing IL-2, TNFα and/or IFNγ at Day 8 or Day 29 higher than the percentile 95 of the pre-injection baseline (Day 1)
Time frame: At Day 1 and Day 8
Geometric Mean Titer of anti-Nucleoprotein immunoglobulin G (Enzyme-Linked Immunosorbent Assay, serum).
Time frame: At Day 1 and Day 8
Number and percentage of subjects with a four-fold increase of anti-Nucleoprotein immunoglobulin G (Enzyme-Linked Immunosorbent Assay, serum) titre with respect to pre-injection baseline (Day 1)
Time frame: At Day 1 and Day 8
Percentage of NP specific CD4+ and CD8+ T-cell measured by flow cytometry on PBMCs as expressing IL-2, TNFα and/or IFNγ in a limited subset of 56 subjects
Time frame: At Day 1 and Day 8
Anti-Nucleoprotein immunoglobulin G measured by Enzyme-Linked Immunosorbent Assay in, serum in a limited subset of 56 subjects.
Time frame: At Day 1 and Day 8
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 16 Oct 2026.
- 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.
16 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OVX836 480µg and Saline Solution in people with Influenza, run by Osivax at 16 sites in 4 countries.
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 8 inclusion and 28 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 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Finland, Belgium, France, Germany. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
First occurrence of RT-PCR-confirmed influenza Type A symptomatic disease (time frame: During the whole study duration, up to maximum 10 months). 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 16 Oct 2026.