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NCT05501561 · ClinicalTrials.gov registry record · Phase 2
Safety and Immunogenicity of Different Formulations of an MF59-Adjuvanted Influenza Vaccine in Older Adults ≥50 Years of Age
A Phase 2 study, sponsored by Seqirus.
- Completed
- Registry status
- Phase 2
- Development phase
- 1,056
- Enrollment target
NCT05501561 is a Phase 2 study that has completed, run by Seqirus. The registered enrollment target is 1,056 participants.
The verdict
NCT05501561, a Phase 2 study, has completed, sponsored by Seqirus.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1,056 participants
- Enrollment target
Study Summary
This Phase 2, randomized, observer-blind, dose-confirmation clinical study evaluated different formulations of MF59-Adjuvanted Quadrivalent Subunit Inactivated Influenza Vaccine. Approximately 1000 subjects were randomized into 1 of 4 possible treatment groups with approximately 250 participants per group. Every participant received an influenza vaccine injection on Day 1 and were to be followed up for approximately 6 months following injection. The primary immunogenicity analysis is based on Day 29 serology data.
Interventions
- BIOLOGICAL Experimental: IIV-A Investigational IIV-A administered as a single dose intramuscularly on Day 1
- BIOLOGICAL Experimental: aIIV-B Investigational aIIV-B administered as a single dose intramuscularly on Day 1
- BIOLOGICAL Experimental: aIIV-C Investigational aIIV-C administered as a single dose intramuscularly on Day 1
- BIOLOGICAL Active Comparator: Licensed IIV IIV administered as a single dose intramuscularly on Day 1
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,056 participants |
| Start Date | 2022-08-25 |
| Est. Completion | 2023-03-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05501561
The ClinicalTrials.gov registry entry for NCT05501561 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 1,056 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 4 interventions - of which Experimental: IIV-A Investigational IIV-A administered as a single dose intramuscularly on Day 1 is the first listed.
NCT05501561 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05501561 about?
NCT05501561 is a clinical study titled "Safety and Immunogenicity of Different Formulations of an MF59-Adjuvanted Influenza Vaccine in Older Adults ≥50 Years of Age". This Phase 2, randomized, observer-blind, dose-confirmation clinical study evaluated different formulations of MF59-Adjuvanted Quadrivalent Subunit Inactivated Influenza Vaccine. Approximately 1000 subjects were randomized into 1 of 4 possible treatment groups with approximately 250 participants per...
What is the current status of trial NCT05501561?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,056 participants. The study started on 2022-08-25. Estimated completion is 2023-03-31.
What interventions are being tested in trial NCT05501561?
The interventions under investigation include: Experimental: IIV-A Investigational IIV-A administered as a single dose intramuscularly on Day 1 (BIOLOGICAL), Experimental: aIIV-B Investigational aIIV-B administered as a single dose intramuscularly on Day 1 (BIOLOGICAL), Experimental: aIIV-C Investigational aIIV-C administered as a single dose intramuscularly on Day 1 (BIOLOGICAL), Active Comparator: Licensed IIV IIV administered as a single dose intramuscularly on Day 1 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05501561?
This trial is sponsored by Seqirus, which has 25 total clinical trials registered on ClinicalTrials.gov.
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