Efficacy, Immunogenicity and Safety of OVX836 Influenza Vaccine 480μg

NCT05569239 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2850

Last updated 2025-12-17

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

OVX836 480µg

One single administration intramuscularly at Day 1.

BIOLOGICAL

Saline Solution

One single administration intramuscularly at Day 1.

Sponsors & Collaborators

  • Osivax

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-08
Primary Completion
2026-05-29
Completion
2026-05-29
FDA Drug
Yes

Countries

  • Belgium
  • Finland
  • France
  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05569239 on ClinicalTrials.gov