NCT06582277

Safety and Immunogenicity of Two Dose Levels of OVX836 Influenza Vaccine as a Booster on Participants Previously Administered With OVX836

Phase 2a, Single Center, Randomized, Double-blind, Study to Evaluate the Immunogenicity and Safety of One Single Administration of OVX836 Influenza Vaccine at Two Dose Levels (180µg or 480μg) Given Intramuscularly (IM), Either as a Booster or a Primary Vaccination in Healthy Adults Previously Administered With OVX836, Influvac Tetra® or Placebo in the OVX836-002 (EudraCT Number: 2019-002939-28) and OVX836-003 (EudraCT Number: 2021-002535-39) Studies.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: Osivax · Industry
• Sex: All
• Age: 20 Years – 64 Years
• Healthy volunteers: Accepted

Summary

This phase 2a is designed to evaluate the anamnestic response of a booster dose (either 180 µg or 480 µg) of OVX836 influenza vaccine administered intramuscularly to participants vaccinated three to five years ago in OVX836-002 or OVX836-003 studies. Participants who had received a placebo or Influvac Tetra® in previous studies would serve as controls and would receive the highest dose of OVX836 vaccine (480 µg) as a primary vaccination.

Detailed description

This is a phase 2a, single center, randomized, double-blind study designed to evaluate the immunogenicity and safety of one single administration of OVX836 influenza vaccine at two dose levels (180μg or 480μg) given intramuscularly, either as a booster or a primary vaccination in approximately 160 to 220 healthy participants (aged 20-64 years) previously administered with OVX836, Influvac Tetra® or placebo in the OVX836-002 (EudraCT number: 2019-002939-28) and OVX836-003 (EudraCT number: 2021-002535-39) studies. This includes OVX836-002 participants who had received 180μg OVX836 during the influenza season 2019-2020 and OVX836-003 participants who had received 180μg, 300μg or 480μg OVX836 before the influenza season 2021-2022. Volunteers who received either Influvac Tetra® in the OVX836-002 study or a placebo in the OVX836-003 study will serve as controls and will receive a primary single dose of OVX836 480μg.

Conditions

• Vaccine-Preventable Diseases
• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	OVX836 shot	One single administration intramuscularly at Day 1.

Timeline

• Start date: 2024-10-22
• Primary completion: 2025-06-02
• Completion: 2025-06-02
• First posted: 2024-09-03
• Last updated: 2025-06-06

Locations

1 site across 1 country: Belgium