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NCT06015282 · ClinicalTrials.gov registry record · Phase 3
The Celljuvant Study: A Phase 3 Immunogenicity and Safety Study of aQIVc Vaccine in Adults Aged 50 Years and Older
A Phase 3 study, sponsored by Seqirus.
- Completed
- Registry status
- Phase 3
- Development phase
- 7,741
- Enrollment target
NCT06015282 is a Phase 3 study that has completed, run by Seqirus. The registered enrollment target is 7,741 participants.
The verdict
NCT06015282, a Phase 3 study, has completed, sponsored by Seqirus.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 7,741 participants
- Enrollment target
Study Summary
This is a Phase 3, randomized, parallel-group, comparator-controlled, observer-blind, multicenter study of immunogenicity and safety in approximately 7700 male and female adults aged 50 years and older (approximately equally split between two age groups: 50-64 years; 65 years and older), who are healthy or have stable comorbidities that increase their risk of complications from influenza infection. Three lots of aQIVc will be evaluated for consistency and pooled for the comparison with the 2 control vaccines. Subjects will be randomly assigned to receive 1 of 3 lots of aQIVc, QIVr, or aQIV in a 1:1:1:2:2 ratio (for a 3:2:2 ratio for aQIVc, QIVr, and aQIV). The study will have a treatment period (Day 1 to Day 29) and a follow-up period (Day 30 up to Day 181); a subset of 770 subjects will be followed up up to Day 365.
Interventions
- BIOLOGICAL Investigational aQIVc
- BIOLOGICAL licensed QIVr
- BIOLOGICAL licensed aQIV
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7,741 participants |
| Start Date | 2023-11-03 |
| Est. Completion | 2025-01-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06015282
The ClinicalTrials.gov registry entry for NCT06015282 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 7,741 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Seqirus, which has 25 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Investigational aQIVc is the first listed.
NCT06015282 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06015282 about?
NCT06015282 is a clinical study titled "The Celljuvant Study: A Phase 3 Immunogenicity and Safety Study of aQIVc Vaccine in Adults Aged 50 Years and Older". This is a Phase 3, randomized, parallel-group, comparator-controlled, observer-blind, multicenter study of immunogenicity and safety in approximately 7700 male and female adults aged 50 years and older (approximately equally split between two age groups: 50-64 years; 65 years and older), who are hea...
What is the current status of trial NCT06015282?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 7,741 participants. The study started on 2023-11-03. Estimated completion is 2025-01-30.
What interventions are being tested in trial NCT06015282?
The interventions under investigation include: Investigational aQIVc (BIOLOGICAL), licensed QIVr (BIOLOGICAL), licensed aQIV (BIOLOGICAL).
Who is sponsoring clinical trial NCT06015282?
This trial is sponsored by Seqirus, which has 25 total clinical trials registered on ClinicalTrials.gov.
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