Immunogenicity and Safety of the Concomitant Administration of OVX836 Influenza Vaccine, Quadrivalent Inactivated Influenza Vaccines and Placebo in Healthy Subjects.
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): OVX836 480µg; Fluarix Tetra; Afluria Quad; Placebo
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomized (1:1:1:1:1:1) into 6 groups of 100 subjects to receive:
First group: OVX836 480µg and Fluarix Tetra at commercial dose administered intramuscularly concomitantly into opposite arms.
Second group: OVX836 480µg and Afluria Quad at commercial dose administered intramuscularly concomitantly into opposite arms.
Third group: OVX836 480µg, concomitantly administered with placebo, intramuscularly into opposite arms.
Fourth group: Fluarix Tetra at commercial dose, concomitantly administered with placebo, intramuscularly into opposite arms.
Fifth group: Afluria Quad at commercial dose, concomitantly administered with placebo, intramuscularly into opposite arms.
Sixth group: placebo administered intramuscularly as two concomitant injections into opposite arms.
Masking: Double (Participant, Investigator)
Primary purpose: Prevention