Efficacy, Immunogenicity and Safety of OVX836 Influenza Vaccine 480μg

NCT05569239 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: OVX836-005
• Study Type: interventional
• Target: 2,850
• Locations: 4 countries
• Sites: 16

Brief 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

Influenza

Outcome Measures

Primary Outcomes (1)

• First occurrence of RT-PCR-confirmed influenza Type A symptomatic disease

  During the whole study duration, up to maximum 10 months

Secondary Outcomes (16)

• First occurrence of RT-PCR-confirmed influenza symptomatic disease irrespective of strain/type.

  During the whole study duration, up to maximum 10 months.

• First of occurrence of RT-PCR-confirmed influenza Type B symptomatic disease

  During the whole study duration, up to maximum 10 months

• Number of subtype of virus in RT-PCR-confirmed influenza Type A cases.

  During the whole study duration, up to maximum 10 months

• Severity and duration of Influenza Like Illness episodes

  During the whole study duration, up to maximum 10 months

• First occurence of clinical influenza-like disease irrespective of causal agent

  During the whole study duration, up to maximum 10 months

Study Arms (2)

OVX836 480µg

EXPERIMENTAL

Adjuvant-free recombinant influenza candidate vaccine based on Nucleoprotein in the influenza virus. One single administration intramuscularly of 480µg dose on Day1.

Biological: OVX836 480µg

Placebo

PLACEBO COMPARATOR

Saline solution (B. Braun Ecoflac Plus) Saline solution (Nacl 0.9%), B. Braun Ecoflac Plus 50mL. One single administration intramuscularly of a 0.8mL dose on Day1.

Biological: Saline Solution

Interventions

OVX836 480µg BIOLOGICAL

One single administration intramuscularly at Day 1.

OVX836 480µg

Saline Solution BIOLOGICAL

One single administration intramuscularly at Day 1.

Placebo

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Written informed consent
• Healthy male or female subjects, as determined by medical history and medical examination.
• Between the ages of 18 and 59 years, inclusive.
• Subject socially active: living in a family with children or with other house-hold members, having frequent social contacts at university, work, in public places such as restaurants, theaters, public transportation, etc.
• Subjects compliant with the reproductive criteria for male and female participants .
• Reliable and willing to make themselves available for the duration of the study, and willing and able to follow study procedures
• Able to read, understand and complete an electronic Diary and electronic Patient Reported Outcome.
• Able to read and sign the subject information sheet and informed consent form (ICF).

You may not qualify if:

• Previous vaccination with an authorized or experimental seasonal, zoonotic or pandemic influenza vaccine within 6 months before the day of vaccination or planned to receive it during the whole study period.
• Formal indication for influenza vaccination on an individual basis according to local recommendations, for example based on occupational risk, or underlying medical conditions. An informed subject who would refuse to get the regular influenza vaccination would be allowed to participate in this study.
• Any known or suspected immunodeficient conditions.
• Past or current history of significant autoimmune diseases, as judged by the Investigator.
• Known or suspected infection with human immunodeficiency virus, hepatitis C virus, or hepatitis B virus.
• Current history of significant uncontrolled medical illness such as diabetes, hypertension, heart, renal or hepatic diseases, as judged by the Investigator.
• Planned absences without access to the investigational site, i.e. vacation or business trips, for more than 7 consecutive days during the study period
• Pregnant or lactating woman.
• Females planning to become pregnant or planning to discontinue contraceptive precautions until the end of the trial.
• Having received another vaccine within 1 month prior to the day of study vaccination, except COVID-19 vaccines for which the minimum time period should be two weeks prior to study vaccination.
• Having participated or currently participating in an OVX836 study or in the OVX-FLU-002 study.
• Planning to receive any other vaccines during the first 28 days following the study vaccine administration, except COVID-19 vaccines which can be administered from 14 days following the study vaccine administration.
• Administration of any investigational or non-registered drug or vaccine within 1 months prior to the administration of study vaccines, or planned administration of any such product during the whole study period.
• History of receiving blood, blood components or immunoglobulins within 3 months prior to the day of vaccination, or planned to receive such product during the whole study period.
• Diagnosed long COVID-19 subjects. 17. Presence of a condition in the ear-nose-throat area, such as nasal septum deviation, atrophic rhinitis, etc…, that could render nasal and nasopharyngeal swabs more difficult to perform, or increase the risk of bleeding; to be confirmed by medical history question and inspection of nasal passage.

Sponsors & Collaborators

• Osivax: lead

Study Sites (16)

Site BE-02

Antwerp, Belgium

Location

Site BE-03

Antwerp, Belgium

Location

Site BE-01

Ghent, Belgium

Location

Site BE-04

Mechelen, Belgium

Location

Site FI-12

Espoo, Finland

Location

Site FI-08

Helsinki, Finland

Location

Site FI-13

Jarvenpaa, Finland

Location

FI-14

Kokkola, Finland

Location

Site FI-11

Oulu, Finland

Location

Site FI-15

Seinäjoki, Finland

Location

Site FI-09

Tampere, Finland

Location

Site FI-10

Turku, Finland

Location

Site FR-05

Lyon, France

Location

Site FR-07

Paris, France

Location

Site FR-06

Rennes, France

Location

Site DE-16

München, Germany

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A total number of 2,850 subjects are planned to be randomized (in a 1:1 ratio) into 2 groups to receive a single intramuscular injection of either OVX836 (480μg) or placebo.

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: October 6, 2022
• Study Start: September 8, 2025
• Primary Completion: May 29, 2026
• Study Completion: May 29, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FI (8); DE (1); FR (3); BE (4)