NCT05569239

Efficacy, Immunogenicity and Safety of OVX836 Influenza Vaccine 480μg

Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Immunogenicity and Safety of One Dose of OVX836 Influenza Vaccine 480μg, After Intramuscular Administration in Healthy Subjects Aged 18-59 Years

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2,850 (estimated)
• Sponsor: Osivax · Industry
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

Summary

The present study will evaluate the efficacy, immunogenicity and safety of one dose of OVX836 influenza vaccine 480μg, after intramuscular administration in healthy subjects aged 18-59 years.

Detailed description

This Phase 2b proof-of-concept field efficacy study is designed as a randomized, double-blind, parallel groups, placebo-controlled, multi-country, multicenter clinical trial. This design of prospective interventional trial is the gold standard in evaluating absolute efficacy of a product in preventing a disease or an outcome. An adequate number of observations is ensured by the multicenter approach.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	OVX836 480µg	One single administration intramuscularly at Day 1.
BIOLOGICAL	Saline Solution	One single administration intramuscularly at Day 1.

Timeline

• Start date: 2025-09-08
• Primary completion: 2026-05-29
• Completion: 2026-05-29
• First posted: 2022-10-06
• Last updated: 2025-12-17

Locations

16 sites across 4 countries: Belgium, Finland, France, Germany

Regulatory

• FDA-regulated drug study