drugset / Trial / NCT06582277
Safety and Immunogenicity of Two Dose Levels of OVX836 Influenza Vaccine as a Booster on Participants Previously Administered With OVX836
Phase 2
Completed
117 enrolled
Osivax
Clinfidence · collabHarmony Clinical Research BVBA · collabInferential · collabKCAS Bio · collabUniversity Hospital, Ghent · collab
RandomizedParallel-groupDouble-blindPrevention
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.
Timeline
- Start
- 2024-10-22
- Primary completion
- 2025-06-02
- Completion
- 2025-06-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | OVX836 | Vaccine | 180 ug | Intramuscular |
| Subject | OVX836 | Vaccine | 480 ug | Intramuscular |