InfluenzaPhase 2NCT05734040
Immunogenicity and Safety of the Concomitant Administration of OVX836 Influenza Vaccine, Quadrivalent Inactivated Influenza Vaccines and Placebo in Healthy Subjects.
A Phase 2 study testing OVX836 480µg, Fluarix Tetra and Afluria Quad in people with Influenza, run by Osivax at 9 sites in Australia.
Trial summary
The present study OVX836-006 aims principally to: Confirm feasibility of the concomitant administration of the vaccines under normal clinical conditions, i.e. as two separate concomitant injections into opposite arms; Introduce an additional representative brand of Quadrivalent Inactivated Influenza Vaccines … Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- OVX836 480µg, Fluarix Tetra and Afluria Quad
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 478 participants
- Where
- 9 sitesAustralia
- Study dates
- 10 May 2023to 15 Jan 2024
- 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 60 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.
- Aged 18 to 60 years.
- Subjects who have received at least two doses of a licensed severe acute respiratory syndrome Coronavirus 2 vaccine.
- 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, and availability of a person who can complete the electronic diary/electronic patient reported outcome in case of illness.
Who cannot join
- Subjects with a body mass index ≤19 kg/m² or ≥40 kg/m² on the day of vaccination.
- Previous influenza vaccination within 6 months before the day of vaccination or planned to receive influenza vaccination during the whole study period.
- 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, recent (<6 months since completion) or ongoing gender reassignment during the study.
- Female subjects: pregnant, breast-feeding or of childbearing potential without appropriate contraceptive methods in place for 2 months before enrolment, or with positive pregnancy test on the day of vaccination. Appropriate contraceptive methods are to be maintained until the end of the trial. Appropriate contraceptive methods are defined by the Clinical Trial Facilitation Group as follow: "Contraceptive methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods. Such methods include: combined (estrogen- and progestogencontaining) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable intrauterine device, intrauterine hormone-releasing system), bilateral tubal occlusion, vasectomized partner and/or sexual abstinence (refraining from heterosexual intercourse)."
- Having received another vaccination within 3 months prior to the day of study vaccination for live attenuated vaccines, or within 1 month prior to the day of study vaccination for inactivated vaccines, except Coronavirus Disease 2019 vaccine.
- Planning to receive other vaccines during the first 28 days following the study vaccine administration.
- Having received a Coronavirus Disease 2019 vaccination within 2 weeks prior to the day of study vaccination.
- Planning to receive Coronavirus Disease 2019 vaccine during the first week (within 7 days) following the study vaccine administration. An interval of preferably 14 days is recommended.
- Administration of any investigational (including OVX836) or non-registered drug or vaccine within 3 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).
- Long Coronavirus Disease, either ongoing or recently recovered.
- 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.
- Presence of tattoos at the level of one of the deltoid muscle.
- Past or current history of any progressive or severe uncontrolled neurological disorder, seizure disorder or Guillain-Barré syndrome.
- 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.
- Past (stopped less than 6 months before enrolment) or current smoking habit above 10 cigarettes per day.
- Past (stopped less than 6 months before enrolment) or current history of alcohol abuse or use of recreational drugs.
- Treatment that can affect immune response such as systemic or high dose inhaled corticosteroids (>800μg/day beclomethasone or equivalent; occasional inhaled corticosteroids for asthma therapy are allowed), radiation treatment, cytotoxic drugs, or current or recent (within 30 days before study entry) chronic or prolonged (>10 days) use of systemic non-steroidal anti-inflammatory drugs, acetylsalicylic acid, paracetamol, ibuprofen, interferon, immunomodulators, allergy shots, as judged by the Investigator. Occasional, non-continuous use of acetylsalicylic acid, paracetamol, ibuprofen or non-steroidal anti-inflammatory drugs on an as-needed basis is allowed.
- Prophylactic or therapeutic use of any anti(retro)virals by systemic route during the study. Topical application is allowed.
- History of severe allergic reactions and/or anaphylaxis, or serious adverse reactions to vaccines or allergy to kanamycin, eggs (especially ovalbumin and chicken proteins), neomycin, polymyxin, formaldehyde and octoxinol-9 (triton-X-100).
- Any contraindication to intramuscular administration, as judged by the Investigator.
- 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.
- 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
9 sites in 1 country.
9 sites in 1 country
Australia9 sites
CMAX Fusion Clinical Research
Adelaide, South Australia, 5000
Paratus Clinical Research Brisbane
Brisbane, Queensland, 4010
Mater Misericordiae Limited
Brisbane, Queensland, 4101
Paratus Clinical Research Central Coast
Kanwal, New South Wales, 2259
Emeritus
Melbourne, Victoria, 3124
UniSC Clinical Trials Moreton Bay
Morayfield, Queensland, 4506
University of Sunshine Coast
Sippy Downs, Queensland, 4556
Emeritus Research Sydney
Sydney, New South Wales, 2019
Paratus Clinical Research Western Sydney
Sydney, New South Wales, 2148
About this study
Official title: Phase 2a, Randomized, Double-blind (Double-dummy), Double Placebo-controlled, Parallel-group Study to Evaluate the Immunogenicity and the Safety of the Concomitant Administration of OVX836 Influenza Vaccine and Quadrivalent Inactivated Influenza Vaccines (QIVs: Fluarix Tetra and Afluria Quad) Given Intramuscularly as 2 Separate Injections Into Opposite Arms, in Comparison to the Concomitant Administration of Quadrivalent Inactivated Influenza Vaccines and Placebo, and OVX836 and Placebo Given the Same Way in Healthy Subjects Aged 18 to 60 Years.
The present study OVX836-006 aims principally to:
- Confirm feasibility of the concomitant administration of the vaccines under normal clinical conditions, i.e. as two separate concomitant injections into opposite arms;
- Introduce an additional representative brand of Quadrivalent Inactivated Influenza Vaccines ;
- Demonstrate the absence of interaction between OVX836 and Quadrivalent Inactivated Influenza Vaccines on the Hemagglutinin response;
- Demonstrate the absence of interaction between OVX836 and Quadrivalent Inactivated Influenza Vaccines on the nucleoprotein response;
- Evaluate the absolute vaccine efficacy of OVX836 compared to placebo in order to corroborate the efficacy signals previously detected in the OVX836 previous studies;
- Evaluate the combined vaccine efficacy of OVX836 + Quadrivalent Inactivated Influenza Vaccines versus OVX836 + placebo, and versus double placebo.
Read the detailed description
Phase 2a, randomized, double-blind, double placebo-controlled, parallel-group study to evaluate the immunogenicity and the safety of the concomitant administration of :
- OVX836 influenza vaccine and Fluarix Tetra;
- OVX836 influenza vaccine and Afluria Quad;
- Fluarix Tetra and placebo;
- Afluria Quad and placebo;
- OVX836 influenza vaccine and placebo;
- Placebo and Placebo; given intramuscularly as 2 separate injections into opposite arms in healthy subjects.
- Conditions
- Influenza
- Being tested
- OVX836 480µg, Fluarix Tetra, Afluria Quad, Placebo
- 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
Fluarix TetraBiological
One single administration intramuscularly at Day 1
Afluria QuadBiological
One single administration intramuscularly at Day 1
PlaceboBiological
One single administration intramuscularly at Day 1
| Study group | Role | What they receive |
|---|---|---|
| OVX836 480µg + Fluarix Tetra at commercial dose | Experimental | OVX836: Adjuvant-free recombinant influenza candidate vaccine based on Nucleoprotein of the influenza virus. One single administration intramuscularly of 480µg dose on Day 1 AND Fluarix Tetra: Inactivated and purified split influenza vaccine. One single administration intramuscularly in the opposite arm on Day 1. Receives: Biological: OVX836 480µg; Biological: Fluarix Tetra |
| OVX836 480µg + Afluria Quad at commercial dose | Experimental | OVX836: Adjuvant-free recombinant influenza candidate vaccine based on Nucleoprotein of the influenza virus. One single administration intramuscularly of 480µg dose on Day 1 AND Afluria Quad: Inactivated and purified split influenza vaccine. One single administration intramuscularly in the opposite arm on Day 1. Receives: Biological: OVX836 480µg; Biological: Afluria Quad |
| Fluarix Tetra at commercial dose + Placebo | Active comparator | Fluarix Tetra: Inactivated and purified split influenza vaccine. One single administration intramuscularly in the opposite arm on Day 1.
AND Placebo Comparator: Saline solution (B. Braun Ecoflac Plus) Saline solution (NaCl 0,9%), B. Braun Ecoflac Plus 50 milliliter. One single administration intramuscularly of a 0.8 milliliter dose in the opposite arm on Day 1. Receives: Biological: Fluarix Tetra; Biological: Placebo |
| Afluria Quad at commercial dose + Placebo | Active comparator | Afluria Quad: Inactivated and purified split influenza vaccine. One single administration intramuscularly on Day 1.
AND Placebo Comparator: Saline solution (B. Braun Ecoflac Plus) Saline solution (NaCl 0,9%), B. Braun Ecoflac Plus 50 milliliter. One single administration intramuscularly of a 0.8 milliliter dose in the opposite arm on Day 1. Receives: Biological: Afluria Quad; Biological: Placebo |
| OVX836 480µg + Placebo | Placebo comparator | OVX836: Adjuvant-free recombinant influenza candidate vaccine based on Nucleoprotein of the influenza virus. One single administration intramuscularly of 480µg dose on Day 1 AND Placebo Comparator: Saline solution (B. Braun Ecoflac Plus) Saline solution (NaCl 0,9%), B. Braun Ecoflac Plus 50 milliliter. One single administration intramuscularly of a 0.8 milliliter dose in the opposite arm on Day 1. Receives: Biological: OVX836 480µg; Biological: Placebo |
| Placebo + Placebo | Placebo comparator | Placebo Comparator: Saline solution (B. Braun Ecoflac Plus) Saline solution (NaCl 0,9%), B. Braun Ecoflac Plus 50 milliliter. One single administration intramuscularly of a 0.8 milliliter dose on Day 1 AND Placebo Comparator: Saline solution (B. Braun Ecoflac Plus) Saline solution (NaCl 0,9%), B. Braun Ecoflac Plus 50 milliliter. One single administration intramuscularly of a 0.8 milliliter dose in the opposite arm on Day 1. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of seroconversion determined using Hemagglutination-Inhibition assay, for the four influenza strains contained in the Quadrivalent Inactivated Influenza Vaccines.
Seroconversion is defined as a negative pre-vaccination Hemagglutination-Inhibition assay titer and post-vaccination Hemagglutination-Inhibition assay titer ≥1:40, or a fourfold increase in Hemagglutination-Inhibition assay titer between pre- and post-vaccination timepoints.
Measured: At Day 29 versus pre-injection baseline (Day 1)
Proportion of subjects achieving a titer ≥1:40 at Day 29 determined using Hemagglutination-Inhibition assay, for the four influenza strains contained in the Quadrivalent Inactivated Influenza Vaccine.
Measured: At Day 29
Number of Hemagglutination-Inhibition assay titers geometric mean ratios >2.5 for the four influenza strains contained in the Quadrivalent Inactivated Influenza Vaccines.
Measured: At Day 29 versus pre-injection baseline (Day 1)
Proportion of subjects reporting solicited local (Injection site redness, Injection site swelling, Injection site pain) and systemic signs and symptoms (Fatigue, Headache, Arthralgia, Malaise, Myalgia, Fever)
Measured: During 7 days after vaccine administration
Proportion of subjects reporting unsolicited Adverse Events
Measured: During 29 days after vaccine administration
Proportion of subjects reporting Serious Adverse Events
Measured: During the whole study duration, 180 days
Secondary outcomes (6)
Hemagglutination-Inhibition assay geometric mean titers for each of the four strains contained in the Quadrivalent Inactivated Influenza Vaccines.
Measured: At Day 1 (pre-injection baseline) and Day 29
Number of laboratory-confirmed influenza A or B cases.
Measured: During the whole study duration, 180 days
Severity scores of Influenza-Like-Illness cases (as per Flu-PRO questionnaire)
Measured: During the whole study duration, 180 days
Cell-mediated immune response in terms of change of Nucleoprotein-specific T-cell frequencies in Peripheral Blood Mononuclear Cells, measured by Interferon Gamma Enzyme-Linked Immunospot Assay.
Measured: At Day 8 versus pre-injection baseline (Day 1)
Geometric Mean Titer of anti-Nucleoprotein immunoglobulin G (Enzyme-Linked Immunosorbent Assay, serum).
Measured: At Day 1, Day 8 and Day 29
Proportion of subjects with an increase (four-fold) in anti-Nucleoprotein Immunoglobulin G (Enzyme-Linked Immunosorbent Assay, serum) titer.
Measured: At Day 29 with respect to pre-injection baseline (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start10 May 2023
- Primary completion10 Aug 2023
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Subjects will be randomized (1:1:1:1:1:1) into 6 groups of 100 subjects to receive: * First group: OVX836 480µg and Fluarix Tetra at commercial dose administered intramuscularly concomitantly into opposite arms. * Second group: OVX836 480µg and Afluria Quad at commercial dose administered intramuscularly concomitantly into opposite arms. * Third group: OVX836 480µg, concomitantly administered with placebo, intramuscularly into opposite arms. * Fourth group: Fluarix Tetra at commercial dose, concomitantly administered with placebo, intramuscularly into opposite arms. * Fifth group: Afluria Quad at commercial dose, concomitantly administered with placebo, intramuscularly into opposite arms. * Sixth group: placebo administered intramuscularly as two concomitant injections into opposite arms.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 478 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osivax
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited, Mater Misericordiae Limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05734040
- Sponsor's protocol ID
- OVX836-006
- Status last verified
- Jan 2024
- First submitted
- 9 Feb 2023
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Groth N, Bruhwyler J, Piat E, Tourneur J, Moris P, Penlington M, Nicolas F, Le Vert A. Double-Blind, Randomized, Phase 2a Study to Evaluate the Safety and Immunogenicity of OVX836, a Nucleoprotein-Based Universal Influenza Vaccine, Co-Administered with Fluarix Tetra(R) or Afluria Quad(R). Vaccines (Basel). 2026 Sep 28;14(10):860. doi: 10.3390/vaccines14100860.
PubMed 42931389
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2a, Randomized, Double-blind (Double-dummy), Double Placebo-controlled, Parallel-group Study to Evaluate the Immunogenicity and the Safety of the Concomitant Administration of OVX836 Influenza Vaccine and Quadrivalent Inactivated Influenza Vaccines (QIVs: Fluarix Tetra and Afluria Quad) Given Intramuscularly as 2 Separate Injections Into Opposite Arms, in Comparison to the Concomitant Administration of Quadrivalent Inactivated Influenza Vaccines and Placebo, and OVX836 and Placebo Given the Same Way in Healthy Subjects Aged 18 to 60 Years.
- ClinicalTrials.gov ID
- NCT05734040
- Acronym / sponsor ID
- OVX836-006
- Conditions
- Influenza
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 478 participants (actual)
- Lead sponsor
- OsivaxIndustry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited, Mater Misericordiae Limited
- Study start
- 10 May 2023 (actual)
- Primary completion
- 10 Aug 2023 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 17 Feb 2023 (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 OVX836-006 aims principally to:
- Confirm feasibility of the concomitant administration of the vaccines under normal clinical conditions, i.e. as two separate concomitant injections into opposite arms;
- Introduce an additional representative brand of Quadrivalent Inactivated Influenza Vaccines ;
- Demonstrate the absence of interaction between OVX836 and Quadrivalent Inactivated Influenza Vaccines on the Hemagglutinin response;
- Demonstrate the absence of interaction between OVX836 and Quadrivalent Inactivated Influenza Vaccines on the nucleoprotein response;
- Evaluate the absolute vaccine efficacy of OVX836 compared to placebo in order to corroborate the efficacy signals previously detected in the OVX836 previous studies;
- Evaluate the combined vaccine efficacy of OVX836 + Quadrivalent Inactivated Influenza Vaccines versus OVX836 + placebo, and versus double placebo.
Detailed description
Phase 2a, randomized, double-blind, double placebo-controlled, parallel-group study to evaluate the immunogenicity and the safety of the concomitant administration of :
- OVX836 influenza vaccine and Fluarix Tetra;
- OVX836 influenza vaccine and Afluria Quad;
- Fluarix Tetra and placebo;
- Afluria Quad and placebo;
- OVX836 influenza vaccine and placebo;
- Placebo and Placebo; given intramuscularly as 2 separate injections into opposite arms in healthy subjects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
- Model description
- Subjects will be randomized (1:1:1:1:1:1) into 6 groups of 100 subjects to receive: * First group: OVX836 480µg and Fluarix Tetra at commercial dose administered intramuscularly concomitantly into opposite arms. * Second group: OVX836 480µg and Afluria Quad at commercial dose administered intramuscularly concomitantly into opposite arms. * Third group: OVX836 480µg, concomitantly administered with placebo, intramuscularly into opposite arms. * Fourth group: Fluarix Tetra at commercial dose, concomitantly administered with placebo, intramuscularly into opposite arms. * Fifth group: Afluria Quad at commercial dose, concomitantly administered with placebo, intramuscularly into opposite arms. * Sixth group: placebo administered intramuscularly as two concomitant injections into opposite arms.
| Arm | Type | Receives |
|---|---|---|
| OVX836 480µg + Fluarix Tetra at commercial dose | Experimental | Biological: OVX836 480µg, Biological: Fluarix TetraOVX836: Adjuvant-free recombinant influenza candidate vaccine based on Nucleoprotein of the influenza virus. One single administration intramuscularly of 480µg dose on Day 1 AND Fluarix Tetra: Inactivated and purified split influenza vaccine. One single administration intramuscularly in the opposite arm on Day 1. |
| OVX836 480µg + Afluria Quad at commercial dose | Experimental | Biological: OVX836 480µg, Biological: Afluria QuadOVX836: Adjuvant-free recombinant influenza candidate vaccine based on Nucleoprotein of the influenza virus. One single administration intramuscularly of 480µg dose on Day 1 AND Afluria Quad: Inactivated and purified split influenza vaccine. One single administration intramuscularly in the opposite arm on Day 1. |
| Fluarix Tetra at commercial dose + Placebo | Active comparator | Biological: Fluarix Tetra, Biological: PlaceboFluarix Tetra: Inactivated and purified split influenza vaccine. One single administration intramuscularly in the opposite arm on Day 1. AND Placebo Comparator: Saline solution (B. Braun Ecoflac Plus) Saline solution (NaCl 0,9%), B. Braun Ecoflac Plus 50 milliliter. One single administration intramuscularly of a 0.8 milliliter dose in the opposite arm on Day 1. |
| Afluria Quad at commercial dose + Placebo | Active comparator | Biological: Afluria Quad, Biological: PlaceboAfluria Quad: Inactivated and purified split influenza vaccine. One single administration intramuscularly on Day 1. AND Placebo Comparator: Saline solution (B. Braun Ecoflac Plus) Saline solution (NaCl 0,9%), B. Braun Ecoflac Plus 50 milliliter. One single administration intramuscularly of a 0.8 milliliter dose in the opposite arm on Day 1. |
| OVX836 480µg + Placebo | Placebo comparator | Biological: OVX836 480µg, Biological: PlaceboOVX836: Adjuvant-free recombinant influenza candidate vaccine based on Nucleoprotein of the influenza virus. One single administration intramuscularly of 480µg dose on Day 1 AND Placebo Comparator: Saline solution (B. Braun Ecoflac Plus) Saline solution (NaCl 0,9%), B. Braun Ecoflac Plus 50 milliliter. One single administration intramuscularly of a 0.8 milliliter dose in the opposite arm on Day 1. |
| Placebo + Placebo | Placebo comparator | Biological: PlaceboPlacebo Comparator: Saline solution (B. Braun Ecoflac Plus) Saline solution (NaCl 0,9%), B. Braun Ecoflac Plus 50 milliliter. One single administration intramuscularly of a 0.8 milliliter dose on Day 1 AND Placebo Comparator: Saline solution (B. Braun Ecoflac Plus) Saline solution (NaCl 0,9%), B. Braun Ecoflac Plus 50 milliliter. One single administration intramuscularly of a 0.8 milliliter dose in the opposite arm on Day 1. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Written informed consent.
- Healthy male or female subjects, as determined by medical history and medical examination.
- Aged 18 to 60 years.
- Subjects who have received at least two doses of a licensed severe acute respiratory syndrome Coronavirus 2 vaccine.
- Reliable and willing to make themselves available for the duration of the study, and willing and able to follow study procedures.
Key exclusion criteria (28 listed)
- Subjects with a body mass index ≤19 kg/m² or ≥40 kg/m² on the day of vaccination.
- Previous influenza vaccination within 6 months before the day of vaccination or planned to receive influenza vaccination during the whole study period.
- 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 + Afluria Quad at commercial dose, OVX836 480µg + Fluarix Tetra at commercial dose, OVX836 480µg + Placebo |
| Fluarix TetraOne single administration intramuscularly at Day 1 | Biological | Fluarix Tetra at commercial dose + Placebo, OVX836 480µg + Fluarix Tetra at commercial dose |
| Afluria QuadOne single administration intramuscularly at Day 1 | Biological | Afluria Quad at commercial dose + Placebo, OVX836 480µg + Afluria Quad at commercial dose |
| PlaceboOne single administration intramuscularly at Day 1 | Biological | Afluria Quad at commercial dose + Placebo, Fluarix Tetra at commercial dose + Placebo, OVX836 480µg + Placebo, Placebo + Placebo |
Primary outcome
Number of seroconversion determined using Hemagglutination-Inhibition assay, for the four influenza strains contained in the Quadrivalent Inactivated Influenza Vaccines.
Time frame: At Day 29 versus pre-injection baseline (Day 1)
Seroconversion is defined as a negative pre-vaccination Hemagglutination-Inhibition assay titer and post-vaccination Hemagglutination-Inhibition assay titer ≥1:40, or a fourfold increase in Hemagglutination-Inhibition assay titer between pre- and post-vaccination timepoints.
Proportion of subjects achieving a titer ≥1:40 at Day 29 determined using Hemagglutination-Inhibition assay, for the four influenza strains contained in the Quadrivalent Inactivated Influenza Vaccine.
Time frame: At Day 29
Number of Hemagglutination-Inhibition assay titers geometric mean ratios >2.5 for the four influenza strains contained in the Quadrivalent Inactivated Influenza Vaccines.
Time frame: At Day 29 versus pre-injection baseline (Day 1)
Proportion of subjects reporting solicited local (Injection site redness, Injection site swelling, Injection site pain) and systemic signs and symptoms (Fatigue, Headache, Arthralgia, Malaise, Myalgia, Fever)
Time frame: During 7 days after vaccine administration
Proportion of subjects reporting unsolicited Adverse Events
Time frame: During 29 days after vaccine administration
Proportion of subjects reporting Serious Adverse Events
Time frame: During the whole study duration, 180 days
6 secondary outcomes
Hemagglutination-Inhibition assay geometric mean titers for each of the four strains contained in the Quadrivalent Inactivated Influenza Vaccines.
Time frame: At Day 1 (pre-injection baseline) and Day 29
Number of laboratory-confirmed influenza A or B cases.
Time frame: During the whole study duration, 180 days
Severity scores of Influenza-Like-Illness cases (as per Flu-PRO questionnaire)
Time frame: During the whole study duration, 180 days
Cell-mediated immune response in terms of change of Nucleoprotein-specific T-cell frequencies in Peripheral Blood Mononuclear Cells, measured by Interferon Gamma Enzyme-Linked Immunospot Assay.
Time frame: At Day 8 versus pre-injection baseline (Day 1)
Geometric Mean Titer of anti-Nucleoprotein immunoglobulin G (Enzyme-Linked Immunosorbent Assay, serum).
Time frame: At Day 1, Day 8 and Day 29
Proportion of subjects with an increase (four-fold) in anti-Nucleoprotein Immunoglobulin G (Enzyme-Linked Immunosorbent Assay, serum) titer.
Time frame: At Day 29 with respect to pre-injection baseline (Day 1)
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 25 Jan 2024.
- Derived from this study: PubMed 42931389Groth N, Bruhwyler J, Piat E, Tourneur J, Moris P, Penlington M, Nicolas F, Le Vert A. Double-Blind, Randomized, Phase 2a Study to Evaluate the Safety and Immunogenicity of OVX836, a Nucleoprotein-Based Universal Influenza Vaccine, Co-Administered with Fluarix Tetra(R) or Afluria Quad(R). Vaccines (Basel). 2026 Sep 28;14(10):860. doi: 10.3390/vaccines14100860.
- 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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OVX836 480µg, Fluarix Tetra and Afluria Quad in people with Influenza, run by Osivax at 9 sites in Australia.
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 6 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 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Australia. 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?
Number of seroconversion determined using Hemagglutination-Inhibition assay, for the four influenza strains contained in the Quadrivalent Inactivated Influenza Vaccines. (time frame: At Day 29 versus pre-injection baseline (Day 1)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05734040, which also lists 1 linked publication.
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 25 Jan 2024.