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NCT05875961 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate Immunogenicity, Safety and Tolerability of Adjuvanted and Non-Adjuvanted H2N3 Influenza Vaccines in Adults
A Phase 1 study, sponsored by Seqirus.
- Completed
- Registry status
- Phase 1
- Development phase
- 600
- Enrollment target
NCT05875961: Completed Phase 1 study, sponsored by Seqirus.
NCT05875961 is a Phase 1 study that has completed, run by Seqirus. The registered enrollment target is 600 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (900% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05875961, a Phase 1 study, has completed, sponsored by Seqirus.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 600 participants
- Enrollment target
Study Summary
This Phase 1, randomized, observer-blind, dose-ranging clinical study is evaluating 6 different formulations of MF59-adjuvanted and non-adjuvanted H2N3 influenza vaccine. Approximately 600 healthy adult subjects are to be randomized into 1 of 6 possible treatment groups with 100 subjects per group, stratified by age group (born after or before 1968). Each subject will receive an influenza vaccine injection on Day 1 and Day 22. Subjects will be followed up for approximately 12 months after the second vaccine injection. The primary immunogenicity analysis is based on the Day 1, Day 8, Day 22, Day 29, and Day 43 serology data. The primary safety analysis is based on solicited local and systemic adverse events (AEs) reported within 10 days after each vaccination, unsolicited AEs reported within 3 weeks after each vaccination, and serious AEs (SAEs), medically attended AEs (MAAEs), AEs leading to withdrawal from the study, and AEs of special interest (AESIs) reported throughout the study.
Primary Outcome
GMT (HI) prevaccination
Interventions
- BIOLOGICAL Low dose A/H2N3c + standard dose MF59
- BIOLOGICAL Intermediate dose A/H2N3c + standard dose MF59
- BIOLOGICAL High dose A/H2N3c + standard dose MF59
- BIOLOGICAL High dose A/H2N3c non-adjuvanted
- BIOLOGICAL Lowest dose A/H2N3c + high dose MF59
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2023-06-15 |
| Est. Completion | 2024-11-15 |
| Phase | Phase 1 |
What the finished NCT05875961 record still lists
NCT05875961 is an interventional study that assigns participants to a tested intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (900% higher).
The record links to 0 conditions, and to 5 interventions - of which Low dose A/H2N3c + standard dose MF59 is the first listed.
NCT05875961 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05875961 about?
NCT05875961 is a clinical study titled "Study to Evaluate Immunogenicity, Safety and Tolerability of Adjuvanted and Non-Adjuvanted H2N3 Influenza Vaccines in Adults". This Phase 1, randomized, observer-blind, dose-ranging clinical study is evaluating 6 different formulations of MF59-adjuvanted and non-adjuvanted H2N3 influenza vaccine. Approximately 600 healthy adult subjects are to be randomized into 1 of 6 possible treatment groups with 100 subjects per group, ...
What is the current status of trial NCT05875961?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 600 participants. The study started on 2023-06-15. Estimated completion is 2024-11-15.
What interventions are being tested in trial NCT05875961?
The interventions under investigation include: Low dose A/H2N3c + standard dose MF59 (BIOLOGICAL), Intermediate dose A/H2N3c + standard dose MF59 (BIOLOGICAL), High dose A/H2N3c + standard dose MF59 (BIOLOGICAL), High dose A/H2N3c non-adjuvanted (BIOLOGICAL), Lowest dose A/H2N3c + high dose MF59 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05875961?
This trial is sponsored by Seqirus, which has 25 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05875961's enrollment target sits among peer trials
600 27th of 2000 higher than 1,973 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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