Trial · NCT06028347
Safety, Reactogenicity, and Immunogenicity Study of a Self-Amplifying MRNA Influenza Vaccine in Healthy Adults
NCT06028347, Phase 1, Completed, Seqirus
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety, Reactogenicity, and Immunogenicity Study of a Self-Amplifying MRNA Influenza Vaccine in Healthy Adults. Trials, record NCT06028347. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06028347
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety, Reactogenicity, and Immunogenicity Study of a Self-Amplifying MRNA Influenza Vaccine in Healthy Adults
- NCT number
- NCT06028347
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 96 participants, actual
- Lead sponsor
- Seqirus
- Conditions
- Influenza, Human
- Interventions
- sa-mRNA vaccine Dose 1, sa-mRNA vaccine Dose 2, sa-mRNA vaccine Dose 3, Placebo
- First posted
- 2023-09-08
- Last updated
- 2024-11-27
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number and percentage of subjects with clinically significant abnormal vital signs and/or acute reactions | up to 60 minutes or within 6 hours post vaccination | |
| Primary | Number and percentage of subjects reporting reactogenicity: Solicited local and systemic AEs | Day 1 to Day 14 of each post vaccination period | |
| Primary | Number and percentage of subjects reporting unsolicited AEs | Day 1 to Day 43 | |
| Primary | Number and percentage of subjects reporting AEs leading to study withdrawal, Adverse Events of Special Interest (AESIs), medically attended AEs (MAAEs), and serious adverse events (SAEs). | Day 1 to Day 202 | |
| Primary | Number and percentage of subjects with Grade 3 or greater abnormal clinically significant hematology and chemistry laboratory values | Day 3 to Day 43 | |
| Primary | Number and percentage of subjects with grading shifts in hematology and chemistry laboratory assessments | Day 3 to Day 43 | |
| Primary | Serum antibody titer against the HA glycoprotein in terms of GMT, GMFI, and GMT ratio measured via HI assay | Day 1, Day 22, Day 43 | |
| Primary | Number and percentage of subjects with HAI titer ≥1:10 and <1:10 (lower limit of quantification [LLOQ]) | Day 1, Day 22, Day 43 | |
| Primary | Number and percentage of subjects with HAI titer ≥1:40, ≥1:80, ≥1:160 and ≥1:320 | Day 1, Day 22, Day 43 | |
| Primary | Seroconversion rate (SCR) by HAI assay | Day 1, Day 22, Day 43 | SCR defined as the percentage of subjects with either a prevaccination HAI titer \<1:10 and a post-vaccination HAI titer ≥1:40, or a prevaccination HAI titer ≥1:10 and a ≥4-fold increase in post-vaccination |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes0
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/NCT06028347
GET https://conductscience.org/api/trials/v1/NCT06028347/registered