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| Name | Class |
|---|---|
| Northern Beaches Clinical Research | UNKNOWN |
| Novotech (Australia) Pty Limited | INDUSTRY |
| Harmony Clinical Research BVBA | OTHER |
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The present study will evaluate the concomitant administration of a Quadrivalent Inactivated Influenza Vaccine with the highest dose level of OVX836 (480µg) tested in the clinic to date, for which the likelihood for interference with Quadrivalent Inactivated Influenza Vaccine is considered the highest.
This trial is a Phase 2a, randomized, double-blind, controlled study in 180 adult subjects to compare the immunogenicity and the safety of the concomitant administration (given intramuscularly, in healthy subjects, as 2 separate injections in the same arm) of:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OVX836 480µg + Quadrivalent Inactivated Influenza Vaccine (Fluarix® Tetra) at commercial dose | Experimental | OVX836: Adjuvant-free recombinant influenza candidate vaccine based on Nucleoprotein of the incluenza virus. One single administration intramuscularly of 480µg dose on Day 1 AND Fluarix® Tetra (GlaxoSmithKline Biologicals): Inactivated and purified split influenza vaccine. |
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| Quadrivalent Inactivated Influenza Vaccine (Fluarix® Tetra) at commercial dose + Placebo | Active Comparator | Fluarix® Tetra (GlaxoSmithKline Biologicals): Inactivated and purified split influenza vaccine. AND Placebo Comparator: Saline solution (B. Braun Ecoflac Plus) Saline solution (NaCl 0,9%), B. Braun Ecoflac Plus 50mL. One single administration intrumuscularly of a 0.8mL dose on Day 1 |
|
| OVX836 480µg + Placebo | Placebo Comparator | OVX836: Adjuvant-free recombinant influenza candidate vaccine based on Nucleoprotein of the incluenza 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 50mL. One single administration intrumuscularly of a 0.8mL dose on Day 1 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OVX836 480µg | Biological | One single administration intramuscularly at Day 1 |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of seroconversion determined using Hemagglutination-Inhibition assay, for the four influenza strains contained in the Quadrivalent Influenza Vaccine. | 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. | 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 Influenza Vaccine. | At Day 29 | |
| Number of Hemagglutination-Inhibition assay titers geometric mean ratios >2.5 for the four influenza strains contained in the Quadrivalent Influenza Vaccine. | 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) | During 7 days after vaccine administration | |
| Proportion of subjects reporting unsolicited AEs | During 29 days after vaccine administration | |
| Proportion of subjects with Influenza-Like-Illness cases | During the whole study duration, 180 days | |
| Severity scores of Influenza-Like-Illness cases (as per Flu-PRO questionnaire) | During the whole study duration, 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| Hemagglutination-Inhibition assay geometric mean titers for each of the four strains contained in the Quadrivalent Influenza Vaccine. | At Day 1 (pre-injection baseline) and Day 29 | |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ross Aldrich, MBBS | Northern Beaches Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northern Beaches Clinical Research | Brookvale | New South Wales | 2100 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40573889 | Derived | Groth N, Bruhwyler J, Tourneur J, Piat E, Moris P, Le Vert A, Nicolas F. Safety and Immunogenicity of OVX836, a Nucleoprotein-Based Universal Influenza Vaccine, Co-Administered with Fluarix(R) Tetra, a Seasonal Hemagglutinin-Based Vaccine. Vaccines (Basel). 2025 May 23;13(6):558. doi: 10.3390/vaccines13060558. |
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Randomized assignment (1:1:1) into 3 groups of 60 subjects to receive:
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Double-blind
| Quadrivalent Inactivated Influenza Vaccine (Fluarix® Tetra) | Biological | One single administration intramuscularly at Day 1 |
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| Placebo | Biological | One single administration intramuscularly at Day 1 |
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| Proportion of subjects reporting Serious Adverse Events | During the whole study duration, 180 days |
| At Day 8 versus pre-injection baseline (Day 1) |
| Geometric Mean Titer of anti-Nucleoprotein immunoglobulin G (Enzyme-Linked Immunosorbent Assay, serum). | 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. | At Day 29 with respect to pre-injection baseline (Day 1) |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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