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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06279871 | Immunogenicity and Safety Study of Self-amplifying mRNA COVID-19 Vaccine Administered With Influenza Vaccines in Adults | PHASE3 | COMPLETED | 1,514 | — | — | Mar 27, 2024 | Nov 21, 2024 | Dec 12, 2025 | 29 | Australia, Costa Rica +2 |
Seroconversion was defined as either a pre-vaccination titer below the lower limit of quantitation (LLOQ) and a postvaccination titer ≥4xLLOQ; or a pre-vaccination titer ≥LLOQ and a ≥4-fold increase in post-vaccination titer.
Influenza vaccine strains were A/H1N1, A/H3N2, B/Victoria, and B/Yamagata.
| Arm | Type | Description |
|---|---|---|
| Group 1a (ARCT-2303/Influenza vaccine) | EXPERIMENTAL | Participants will receive one 0.5-mL IM (intramuscular) dose of ARCT-2303 and one 0.5-mL IM dose of influenza vaccine on Day 1 followed by a 0.5-mL IM dose of placebo on Day 29. |
| Group 2a (ARCT-2303) | EXPERIMENTAL | Participants will receive one 0.5-mL IM dose of ARCT-2303 and one 0.5-mL IM dose of placebo on Day 1 followed by a 0.5-mL IM dose of influenza vaccine on Day 29. |
| Group 3a (Influenza vaccine) | ACTIVE_COMPARATOR | Participants will receive one 0.5-mL IM dose of influenza vaccine and one 0.5-mL IM dose of placebo on Day 1 followed by a 0.5-mL IM dose of ARCT-2303 on Day 29. |
| Group 1b (ARCT-2303/ Influenza vaccine) | EXPERIMENTAL | Participants will receive one 0.5-mL IM dose of ARCT-2303 and one 0.5-mL IM dose of influenza vaccine on Day 1 followed by a 0.5-mL IM dose of placebo on Day 29. |
| Group 2b (ARCT-2303) | EXPERIMENTAL | Participants will receive one 0.5-mL IM dose of ARCT-2303 and one 0.5-mL IM dose of placebo on Day 1 followed by a 0.5-mL IM dose of influenza vaccine on Day 29. |
| Group 3b (Influenza vaccine) | ACTIVE_COMPARATOR | Participants will receive one 0.5-mL IM dose of influenza vaccine and one 0.5-mL IM dose of placebo on Day 1 followed by a 0.5-mL IM dose of ARCT-2303 on Day 29. |
| Name | Type | Description |
|---|---|---|
| ARCT-2303 | BIOLOGICAL | Self-Amplifying RNA COVID-19 vaccine (Omicron XBB.1.5) |
| Influenza vaccine | BIOLOGICAL | Licensed cell-based influenza vaccine |
| Influenza vaccine, adjuvanted | BIOLOGICAL | Licensed influenza vaccine, adjuvanted |
| Placebo | OTHER | 0.9% saline |
Inclusion Criteria: 1, Individuals are male, female, or transgender adults ≥18 years of age. 2\. Healthy participants or participants with pre-existing stable medical conditions. 3\. Participant or legally authorized representatives must freely provide documented informed consent prior to study p...