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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05155319 | Universal Influenza A Vaccine in Healthy Adults | PHASE1 | COMPLETED | 27 | — | — | Dec 1, 2021 | Oct 10, 2023 | Jan 20, 2025 | 2 | Australia |
Incidence of AEs up to 4 weeks after last dose. Incidence of SAEs up to 48 weeks of study follow-up. Incidence of AESIs up to 48 weeks of study follow-up. Incidence of MAAEs up to 48 weeks of study follow-up.
Incidences of local reactogenicity events up to 7 days after each vaccination. Incidences of systemic reactogenicity events up to 7 days after each vaccination.
| Arm | Type | Description |
|---|---|---|
| Cohort 1, 1A | ACTIVE_COMPARATOR | Low dose (Day 1) plus placebo (Day 22) |
| Cohort 1, 1B | ACTIVE_COMPARATOR | Low dose (Day 1) plus low dose (Day 22) |
| Cohort 1, 1C | PLACEBO_COMPARATOR | Placebo (Day 1) plus Placebo (Day 22) |
| Cohort 2, 2A | ACTIVE_COMPARATOR | High dose (Day 1) plus placebo (Day 22) |
| Cohort 2, 2B | ACTIVE_COMPARATOR | High dose (Day 1) plus high dose (Day 22) |
| Cohort 2, 2C | PLACEBO_COMPARATOR | Placebo (Day 1) plus Placebo (Day 22) |
| Name | Type | Description |
|---|---|---|
| UFluA 20 µg each antigen/dose | BIOLOGICAL | Low dose |
| UFluA 60 µg each antigen/dose | BIOLOGICAL | High Dose |
| Placebo | BIOLOGICAL | Placebo |
Inclusion Criteria: * Male and female adults (18-45 years of age, inclusive) at the Screening visit. * Body mass index of 18.5-32.0 kg/m\^2 (inclusive) at the Screening visit. * Healthy, based on medical history (no chronic disease, no chronic therapy, no ongoing acute condition within four weeks p...