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.
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.