Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06582277 | Safety and Immunogenicity of Two Dose Levels of OVX836 Influenza Vaccine as a Booster on Participants Previously Administered With OVX836 | PHASE2 | COMPLETED | 117 | — | — | Oct 22, 2024 | Jun 2, 2025 | Jun 6, 2025 | 1 | Belgium |
Description: Proportion of subjects reporting: - solicited local and systemic symptoms within 7 days after vaccine administration - unsolicited AEs within 29 days after vaccine administration - SAEs during the entire study duration - ILIs and RT-PCR confirmed influenza A or B (overall and occurring more than 14 days post-vaccination, i.e., vaccine failure), RSV and/or SARS-CoV-2.
| Arm | Type | Description |
|---|---|---|
| OVX836 - 180μg dose level | EXPERIMENTAL | 180 µg dose of an adjuvant-free recombinant influenza candidate vaccine based on the Nucleoprotein (NP) of the influenza virus. |
| OVX836 - 480μg dose level | EXPERIMENTAL | 480 µg dose of an adjuvant-free recombinant influenza candidate vaccine based on the Nucleoprotein (NP) of the influenza virus. |
| Name | Type | Description |
|---|---|---|
| OVX836 shot | BIOLOGICAL | One single administration intramuscularly at Day 1. |
Inclusion Criteria: 1. Subject who voluntarily provides written informed consent to participate in the study. 2. Healthy male or female subjects, as determined by medical history and medical examination 3. Subject compliant with the reproductive criteria for female participants 4. Subjects who part...