NCT05060887

Immunogenicity and Safety of Three Dose Levels of OVX836 Candidate Vaccine Against Influenza in Healthy Volunteers.

Phase 2a, Single Center, Randomized, Double-blind, Controlled Study to Evaluate the Immunogenicity and the Safety of One Single Administration of OVX836 Influenza Vaccine at Two Dose Levels (300μg and 480μg) Given Intramuscularly (IM), in Comparison to OVX836 Influenza Vaccine at 180μg and Placebo Given IM in Healthy Subjects Aged 18-55 Years and in Healthy Subjects Aged 65 Years and Older.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 239 (actual)
• Sponsor: Osivax · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This Phase 2a clinical trial is designed to evaluate the immunogenicity and the safety of one administration of OVX836 influenza vaccine at different dose levels (180µg, 300μg and 480μg) in order to assess the dose response of the OVX836 influenza vaccine.

Detailed description

This trial is a Phase 2a, randomized, double-blind, controlled study in 138 adult subjects to compare the immunogenicity and the safety of OVX836 influenza vaccine at two dose levels (300μg and 480μg) to lower dose level (180µg) and to placebo. One single dose of OVX836 influenza vaccine (180µg or 300µg or 480µg) or of placebo will be administered intramuscularly in healthy subjects aged 18-55 years and in healthy subjects aged 65 years and older.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	OVX836-003	One single administration intramuscularly at Day 1.
BIOLOGICAL	Saline solution	One single administration intramuscularly at Day 1.

Timeline

• Start date: 2021-11-15
• Primary completion: 2022-02-01
• Completion: 2022-12-07
• First posted: 2021-09-29
• Last updated: 2023-08-31

Locations

1 site across 1 country: Belgium