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NCT06602531 · ClinicalTrials.gov registry record · Phase 1
Safety and Immunogenicity Study of Self-Amplifying RNA Pandemic Influenza Vaccine in Adults
A Phase 1 study, sponsored by Arcturus Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 212
- Enrollment target
NCT06602531 is a Phase 1 study that has completed, run by Arcturus Therapeutics. The registered enrollment target is 212 participants.
The verdict
NCT06602531, a Phase 1 study, has completed, sponsored by Arcturus Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 212 participants
- Enrollment target
Study Summary
The goal of this clinical trial is to evaluate the safety and immune responses of three different dose levels a self-amplifying RNA pandemic influenza vaccine (ARCT-2304) in adults. The key objectives of the study are: * To evaluate safety and reactogenicity of different dose levels of the ARCT-2304 vaccine * To describe the Immune responses of different dose levels of the ARCT-2304 vaccine as measured by hemagglutination inhibition (HAI) and neuraminidase enzyme-linked lectin (ELLA) antibody responses Researchers will compare the results with licensed influenza vaccines to select the most optimal dose level and schedule for vaccine administration in terms of safety and immunogenicity for further development of the vaccine. Participants will receive 2 doses of the ARCT-2304 vaccine or 1 dose of licensed influenza vaccine and 1 dose of placebo. They will be asked: * to complete a daily diary for 7 days after each vaccination, answering questions how they have been feeling on that day. * to provide blood samples at each visit in the clinic * to comply with all study visits and procedures (e.g., be available for planned telephone contacts and unscheduled clinic visits, if required)
Interventions
- BIOLOGICAL ARCT-2304
- BIOLOGICAL Control vaccine (licensed seasonal influenza vaccine) younger adults
- BIOLOGICAL Control vaccine (licensed seasonal influenza vaccine) older adults
- OTHER Placebo Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 212 participants |
| Start Date | 2024-12-10 |
| Est. Completion | 2025-12-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06602531
The ClinicalTrials.gov registry entry for NCT06602531 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 212 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Arcturus Therapeutics, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which ARCT-2304 is the first listed.
NCT06602531 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06602531 about?
NCT06602531 is a clinical study titled "Safety and Immunogenicity Study of Self-Amplifying RNA Pandemic Influenza Vaccine in Adults". The goal of this clinical trial is to evaluate the safety and immune responses of three different dose levels a self-amplifying RNA pandemic influenza vaccine (ARCT-2304) in adults. The key objectives of the study are: * To evaluate safety and reactogenicity of different dose levels of the ARCT-230...
What is the current status of trial NCT06602531?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 212 participants. The study started on 2024-12-10. Estimated completion is 2025-12-05.
What interventions are being tested in trial NCT06602531?
The interventions under investigation include: ARCT-2304 (BIOLOGICAL), Control vaccine (licensed seasonal influenza vaccine) younger adults (BIOLOGICAL), Control vaccine (licensed seasonal influenza vaccine) older adults (BIOLOGICAL), Placebo Vaccine (OTHER).
Who is sponsoring clinical trial NCT06602531?
This trial is sponsored by Arcturus Therapeutics, which has 6 total clinical trials registered on ClinicalTrials.gov.
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