Immunogenicity and Safety of Three Dose Levels of OVX836 Candidate Vaccine Against Influenza in Healthy Volunteers.
NCT05060887 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 239
Last updated 2023-08-31
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.
Conditions
Interventions
- BIOLOGICAL
-
OVX836-003
One single administration intramuscularly at Day 1.
- BIOLOGICAL
-
Saline solution
One single administration intramuscularly at Day 1.
Sponsors & Collaborators
-
Center for vaccinology (CEVAC), University of Ghent
collaborator UNKNOWN -
Osivax
lead INDUSTRY
Principal Investigators
-
Isabel Leroux-Roels, MD, PhD · Centre for Vaccinology (CEVAC), Ghent University Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-11-15
- Primary Completion
- 2022-02-01
- Completion
- 2022-12-07
Countries
- Belgium
Study Locations
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