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| Name | Class |
|---|---|
| Novotech (Australia) Pty Limited | INDUSTRY |
| Mater Misericordiae Limited | UNKNOWN |
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The present study OVX836-006 aims principally to:
Phase 2a, randomized, double-blind, double placebo-controlled, parallel-group study to evaluate the immunogenicity and the safety of the concomitant administration of :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OVX836 480µg | Biological | One single administration intramuscularly at Day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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 Adverse Events | During 29 days after vaccine administration | |
| Proportion of subjects reporting Serious Adverse Events | 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 Inactivated Influenza Vaccines. | At Day 1 (pre-injection baseline) and Day 29 | |
| Number of laboratory-confirmed influenza A or B cases. | During the whole study duration, 180 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Paratus Clinical Research Central Coast | Kanwal | New South Wales | 2259 | Australia | ||
| Emeritus Research Sydney |
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Subjects will be randomized (1:1:1:1:1:1) into 6 groups of 100 subjects to receive:
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Double-blind
|
| 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. |
|
| 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. |
|
| Fluarix Tetra | Biological | One single administration intramuscularly at Day 1 |
|
| Afluria Quad | Biological | One single administration intramuscularly at Day 1 |
|
| Placebo | Biological | One single administration intramuscularly at Day 1 |
|
| Severity scores of Influenza-Like-Illness cases (as per Flu-PRO questionnaire) | 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. | 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) |
| Sydney |
| New South Wales |
| 2019 |
| Australia |
| Paratus Clinical Research Western Sydney | Sydney | New South Wales | 2148 | Australia |
| Paratus Clinical Research Brisbane | Brisbane | Queensland | 4010 | Australia |
| Mater Misericordiae Limited | Brisbane | Queensland | 4101 | Australia |
| UniSC Clinical Trials Moreton Bay | Morayfield | Queensland | 4506 | Australia |
| University of Sunshine Coast | Sippy Downs | Queensland | 4556 | Australia |
| CMAX Fusion Clinical Research | Adelaide | South Australia | 5000 | Australia |
| Emeritus | Melbourne | Victoria | 3124 | Australia |
| 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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