NCT05734040

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

Phase 2a, Randomized, Double-blind (Double-dummy), Double Placebo-controlled, Parallel-group Study to Evaluate the Immunogenicity and the Safety of the Concomitant Administration of OVX836 Influenza Vaccine and Quadrivalent Inactivated Influenza Vaccines (QIVs: Fluarix Tetra and Afluria Quad) Given Intramuscularly as 2 Separate Injections Into Opposite Arms, in Comparison to the Concomitant Administration of Quadrivalent Inactivated Influenza Vaccines and Placebo, and OVX836 and Placebo Given the Same Way in Healthy Subjects Aged 18 to 60 Years.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 478 (actual)
• Sponsor: Osivax · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	OVX836 480µg	One single administration intramuscularly at Day 1
BIOLOGICAL	Fluarix Tetra	One single administration intramuscularly at Day 1
BIOLOGICAL	Afluria Quad	One single administration intramuscularly at Day 1
BIOLOGICAL	Placebo	One single administration intramuscularly at Day 1

Timeline

• Start date: 2023-05-10
• Primary completion: 2023-08-10
• Completion: 2024-01-15
• First posted: 2023-02-17
• Last updated: 2024-01-25

Locations

9 sites across 1 country: Australia