Trial · NCT06015282
The Celljuvant Study: A Phase 3 Immunogenicity and Safety Study of aQIVc Vaccine in Adults Aged 50 Years and Older
NCT06015282, Phase 3, Completed, Seqirus
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Celljuvant Study: A Phase 3 Immunogenicity and Safety Study of aQIVc Vaccine in Adults Aged 50 Years and Older. Trials, record NCT06015282. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06015282
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Celljuvant Study: A Phase 3 Immunogenicity and Safety Study of aQIVc Vaccine in Adults Aged 50 Years and Older
- NCT number
- NCT06015282
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 7,741 participants, actual
- Lead sponsor
- Seqirus
- Conditions
- Influenza, Human
- Interventions
- Investigational aQIVc, licensed QIVr, licensed aQIV
- First posted
- 2023-08-29
- Last updated
- 2025-04-27
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Immunogenicity Endpoint: Humoral immune responses of 3 lots of aQIVc compared in pairs in terms of Day 29 GMT ratio between each pair among the 3 lots, from antibody titers measured via HI assay. | Day 29 | HI assay will be measured using cell-derived target viruses for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains. |
| Primary | Immunogenicity Endpoint: Humoral immune responses of aQIVc in comparison with QIVr and aQIV vaccines in terms of Day 29 GMT and GMT ratio of antibodies measured via HI assay. | Day 29 | HI assay will be measured using cell-derived target viruses for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains. Noninferiority of aQIVc versus comparator (QIVr or aQIV) will be demonstrated if the lower limit (LL) of the 2-sided 97.5% CI for the Day 29 GMT ratio (aQIVc/comparator) is ≥0.67 for each of the 4 vaccine strains. |
| Primary | Immunogenicity Endpoint: Humoral immune responses of aQIVc in comparison with QIVr and aQIV vaccines in terms of Day 1 to Day 29 SCR and SCR difference, from antibody titers measured via HI assay. | Day 1 and Day 29 | HI assay will be measured using cell-derived target viruses for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains. SCR is the percentage of subjects with seroconversion (defined as either a prevaccination \[Day 1\] titer \<1:10 and a postvaccination \[Day 29\] titer ≥1:40, or a prevaccination titer ≥1:10 and a ≥4-fold increase in postvaccination titer). Noninferiority of aQIVc versus comparator (QIVr or aQIV) will be demonstrated if the lower limit (LL) of the 2-sided 97.5% CI for the difference in SCR (aQIVc minus comparator) is ≥-10% for each of the 4 vaccine strains. |
| Secondary | Immunogenicity Endpoint: Humoral immune responses of aQIVc in comparison with aQIV vaccine in terms of Day 29 SCR and SCR difference, GMT and GMT ratio of antibodies measured via HI assay in subjects 65 years and older. | Day 1 and Day 29 | HI assay will be measured using cell-derived target viruses for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains. Noninferiority will be demonstrated if the LL of the 2-sided adjusted CI for the Day 29 GMT ratio (aQIVc/comparator) is ≥0.67 for each of the 4 vaccine strains, and the LL of the 2-sided adjusted CI for the difference in SCR (aQIVc minus comparator) is ≥-10% for each of the 4 vaccine strains. |
| Secondary | Immunogenicity Endpoint: Humoral immune responses of aQIVc in comparison with QIVr and aQIV vaccines in terms of Day 29 GMT and GMT ratio of antibodies measured via HI assay. | Day 29 | HI assay will be measured using cell-derived target viruses for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains. Superiority of aQIVc versus comparator (QIVr and aQIV) will be demonstrated if the LL of the 2-sided 97.5% CI for the inter-group GMT ratio (aQIVc/comparator) is \>1.0 for each of the 4 vaccine strains. |
| Secondary | Immunogenicity Endpoints: For aQIVc, QIVr, and aQIV vaccines, Day 29 GMT, Day 1 to Day 29 GMFI, Percentage of subjects with HI titer ≥1:40 at Day 29, Day 1 to Day 29 SCR, SCR differences and GMT ratio of antibodies measured via HI assay. | Day 1 and Day 29 | HI assay will be measured using cell-derived target viruses for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains, overall and by age subgroup. |
| Secondary | Immunogenicity Endpoints: For aQIVc and aQIV vaccines, Day 29 GMT, Day 1 to Day 29 GMFI, Percentage of subjects with HI titer ≥1:40 at Day 29, Day 1 to Day 29 SCR, SCR differences, and GMT ratio of antibodies measured via HI assay. | Day 1 and Day 29 | HI assay will be measured using egg-derived target viruses for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains in the HI-egg subset of 2750 subjects, overall and by age subgroup. |
| Secondary | Immunogenicity Endpoints: For aQIVc, QIVr and aQIV vaccines, GMT, GMFI, Percentage of subjects with HI titer ≥1:40, SCR, SCR differences, and GMT ratio of antibodies measured via HI assay. | Day 1 up to Day 365 | HI assay will be measured using cell-derived target viruses for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains in the long-term subset of 770 subjects, overall and by age subgroup. |
| Secondary | Immunogenicity Endpoints: For aQIVc, QIVr and aQIV vaccines, GMT, GMFI, SCR, SCR difference, and GMT ratio of antibodies measured via MN assay. | Day 1 up to Day 365 | MN assay will be measured using cell-derived target viruses for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains in the long-term subset of 770 subjects, overall and by age subgroup. |
| Secondary | Safety endpoints: For aQIVc, QIVr and aQIV vaccines, the percentages of Subjects with Solicited Local Adverse Events, Solicited Systemic Adverse Events, and Severe Solicited Local and/or Systemic AEs. | Day 1 to Day 7 |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 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.
Papers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT06015282
GET https://conductscience.org/api/trials/v1/NCT06015282/registered