Trial · NCT06125691
Safety and Immunogenicity First-in-human Dose-ranging Study of Self-Amplifying RNA Seasonal Influenza Vaccine in Adults
NCT06125691, Phase 1, Completed, Arcturus Therapeutics, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Immunogenicity First-in-human Dose-ranging Study of Self-Amplifying RNA Seasonal Influenza Vaccine in Adults. Trials, record NCT06125691. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06125691
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Immunogenicity First-in-human Dose-ranging Study of Self-Amplifying RNA Seasonal Influenza Vaccine in Adults
- NCT number
- NCT06125691
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 139 participants, actual
- Lead sponsor
- Arcturus Therapeutics, Inc.
- Conditions
- Influenza, Human
- Interventions
- ARCT-2138, Licensed Quadrivalent Vaccine for younger adults, Licensed Quadrivalent Vaccine for older adults
- First posted
- 2023-11-09
- Last updated
- 2025-10-03
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of participants reporting local Adverse Events | 14 Days following study vaccination | Solicited local AEs include injection-site pain, erythema and swelling |
| Primary | Percentage of participants reporting systemic Adverse Events | 14 Days following study vaccination | Solicited systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills, and fever. |
| Primary | Percentage of participants reporting unsolicited Adverse Events | 29 Days following study vaccination | Spontaneously reported adverse events and as elicited by investigational site staff |
| Primary | Percentage of participants reporting laboratory or vital signs abnormalities | 29 Days following study vaccination | Abnormal clinically significant values |
| Primary | Percentage of participants reporting serious adverse events, medically attended adverse events adverse events of special interest and adverse events leading early termination | 29 Days following study vaccination | Spontaneously reported adverse events and as elicited by investigational site staff |
| Primary | Serum hemagglutination inhibition (HAI) antibody levels against the HA glycoprotein. | 29 days following study vaccination | HAI antibody levels expressed as GMT, GMFI, SCRs and HAI titers. |
| Primary | Serum neuraminidase enzyme-linked lectin (ELLA) assay antibody levels against the NA glycoproteins. | 29 days following study vaccination | ELLA antibody levels expressed as GMT, GMFI, SCRs and HAI titers. |
| Secondary | Percentage of participants reporting serious adverse events, medically attended adverse events adverse events of special interest and adverse events leading early termination | 181 days following study vaccination | Spontaneously reported adverse events and as elicited by investigational site staff |
| Secondary | Serum hemagglutination inhibition (HAI) antibody levels against the HA glycoprotein. | 181 days following study vaccination | HAI antibody levels expressed as GMT, GMFI, SCRs and HAI titers. |
| Secondary | Serum neuraminidase enzyme-linked lectin (ELLA) assay antibody levels against the NA glycoproteins. | 181 days following study vaccination | ELLA antibody levels expressed as GMT, GMFI, SCRs and HAI titers. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06125691
GET https://conductscience.org/api/trials/v1/NCT06125691/registered