Safety and Immunogenicity Study of Self-Amplifying RNA Pandemic Influenza Vaccine in Adults
← catalyst calendarSponsored by Arcturus Therapeutics, Inc. (industry) · ARCT — their whole pipeline →. With Biomedical Advanced Research and Development Authority.
Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Randomized · Quadruple · Prevention
Enrollment
212actual
Sites
4
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-12-10 | actual | When the study began enrolling |
| Primary completion | 2025-06-13 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-12-05 | actual | The whole study's end, after follow-up |
| First posted | 2024-09-19 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-04-03 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Influenza, Human
Interventions
- Biological: ARCT-2304 — also filed as Self-Amplifying mRNA pandemic Influenza vaccine
- Biological: Control vaccine (licensed seasonal influenza vaccine) younger adults — also filed as Influenza vaccine
- Biological: Control vaccine (licensed seasonal influenza vaccine) older adults — also filed as Influenza vaccine
- Other: Placebo Vaccine — also filed as saline
Primary outcomes
what the primary-completion date above is the date OFPercentage of participants reporting local Adverse Events
measured For 7 days following each study vaccination
Percentage of participants reporting systemic Adverse Events
measured For 7 days following each study vaccination
Percentage of participants reporting unsolicited Adverse Events
measured For 28 days following each study vaccination
Percentage of participants reporting laboratory or vital signs abnormalities
measured For 28 days following each study vaccination
Percentage of participants reporting serious adverse events, medically attended adverse events, adverse events of special interest, and adverse events leading to early termination
measured For 28 days following each study vaccination
Serum hemagglutination inhibition (HAI) antibody levels against the HA glycoprotein
measured For 28 days following study second vaccination
Serum neuraminidase enzyme-linked lectin (ELLA) assay antibody levels against the NA glycoproteins
measured For 28 days following study second vaccination
Posted documents
hosted by the registry — we link, never re-serveInformed Consent Formposted 2024-12-04 · 534 KB · ICF_000.pdf
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