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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
478
One single administration intramuscularly at Day 1
One single administration intramuscularly at Day 1
One single administration intramuscularly at Day 1
One single administration intramuscularly at Day 1
Paratus Clinical Research Central Coast
Kanwal, New South Wales, Australia
Emeritus Research Sydney
Sydney, New South Wales, Australia
Paratus Clinical Research Western Sydney
Sydney, New South Wales, Australia
Paratus Clinical Research Brisbane
Brisbane, Queensland, Australia
Mater Misericordiae Limited
Brisbane, Queensland, Australia
UniSC Clinical Trials Moreton Bay
Morayfield, Queensland, Australia
University of Sunshine Coast
Sippy Downs, Queensland, Australia
CMAX Fusion Clinical Research
Adelaide, South Australia, Australia
Emeritus
Melbourne, Victoria, Australia
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.
Time frame: 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.
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
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)
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