Immunogenicity and Safety of the Concomitant Administration of OVX836 Influenza Vaccine, Quadrivalent Inactivated Influenza Vaccines and Placebo in Healthy Subjects.

Number of seroconversion determined using Hemagglutination-Inhibition assay, for the four influenza strains contained in the Quadrivalent Inactivated Influenza Vaccines.,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.,Number of Hemagglutination-Inhibition assay titers geometric mean ratios 2.5 for the four influenza strains contained in the Quadrivalent Inactivated Influenza Vaccines.,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),Proportion of subjects reporting unsolicited Adverse Events,Proportion of subjects reporting Serious Adverse Events

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 in two strata of subjects aged either
 18-44 years or 45-60 years;
 
 - 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.