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ACTIVE NOT RECRUITING
NCT05569239
PHASE2

Efficacy, Immunogenicity and Safety of OVX836 Influenza Vaccine 480μg

Sponsor: Osivax

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 59 Years

Study Type

INTERVENTIONAL

Enrollment

2850

Start Date

2025-09-08

Completion Date

2026-05-29

Last Updated

2025-12-17

Healthy Volunteers

Yes

Conditions

Interventions

BIOLOGICAL

OVX836 480µg

One single administration intramuscularly at Day 1.

BIOLOGICAL

Saline Solution

One single administration intramuscularly at Day 1.

Locations (16)

Site BE-02

Antwerp, Belgium

Site BE-03

Antwerp, Belgium

Site BE-01

Ghent, Belgium

Site BE-04

Mechelen, Belgium

Site FI-12

Espoo, Finland

Site FI-08

Helsinki, Finland

Site FI-13

Jarvenpaa, Finland

FI-14

Kokkola, Finland

Site FI-11

Oulu, Finland

Site FI-15

Seinäjoki, Finland

Site FI-09

Tampere, Finland

Site FI-10

Turku, Finland

Site FR-05

Lyon, France

Site FR-07

Paris, France

Site FR-06

Rennes, France

Site DE-16

München, Germany