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NCT05044195 · ClinicalTrials.gov registry record · Phase 3
A Clinical Study to Evaluate the Immunogenicity and Safety of an Adjuvanted Quadrivalent Influenza Vaccine Compared With a Licensed Quadrivalent Vaccine in Adults 50 to 64 Years of Age
A Phase 3 study of Influenza, Human, sponsored by Seqirus.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,044
- Enrollment target
- 20
- Study locations
NCT05044195: Completed Phase 3 study of Influenza, Human, sponsored by Seqirus.
NCT05044195 is a Phase 3 study of Influenza, Human that has completed, run by Seqirus. The registered enrollment target is 2,044 participants, below the 16,110-participant average among 18 other Influenza, Human trials with a reported enrollment target (87% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05044195, a Phase 3 study of Influenza, Human, has completed, sponsored by Seqirus.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,044 participants
- Enrollment target
- 20
- Study locations
Study Summary
This Phase 3 study is a randomized, observer-blind immunogenicity and safety study of aQIV (an MF59-adjuvanted quadrivalent influenza vaccine) compared with a licensed quadrivalent influenza vaccine in adults 50 to 64 years of age.
Primary Outcome
The GMT ratio is defined as the geometric mean of the postvaccination HI titer for Comparator QIV over the geometric mean of the postvaccination HI titer for aQIV.
Conditions Studied
Interventions
- BIOLOGICAL aQIV
- BIOLOGICAL Comparator QIV
Study Locations (20)
Other
- 23302 Vee Family Doctors Centre - Paide
- 23301 Innomedica OÜ - Outpatient - Tallinn
- 23303 Al Mare Perearstikeskus OÜ - Tallinn
- 23304 Merelahe Family Doctors Centre - Tallinn
- 23306 Center for Clinical and Basic Research - Tallinn
- 23305 Clinical Research Center - Vaccine Trials - Tartu
- 27602 Klinische Forschung Berlin - Berlin
- 27603 Emovis GmbH - Berlin
Nebraska
- 84009 Meridian Clinical Research - Lincoln
- 84002 Meridian Clinical Research - Norfolk
- 84004 Meridian Clinical Research - Omaha
Florida
- 84005 JEM Research Institute - Atlantis
- 84010 Headlands Research Orlando - Orlando
New York
- 84008 United Medical Associates - Binghamton
- 84011 Meridian Clinical Research - Endwell
Alabama
- 84013 Coastal Clinical Research, Inc. - Mobile
Arizona
- 84007 Alliance for Multispecialty Research - Tempe
Georgia
- 84001 Meridian Clinical Research - Savannah
Iowa
- 84003 Meridian Clinical Research - Sioux City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,044 participants |
| Start Date | 2021-09-30 |
| Est. Completion | 2022-09-09 |
| Phase | Phase 3 |
What the finished NCT05044195 record still lists
NCT05044195 is an interventional study that assigns participants to a tested intervention. Its 2,044 participants enrollment target places it among the larger protocols in the corpus, below the 16,110-participant average among 18 other Influenza, Human trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Influenza, Human appearing as the primary indexed condition, and to 2 interventions - of which aQIV is the first listed.
NCT05044195 names 20 study sites across 9 states, led by Other, Nebraska, Florida.
Frequently Asked Questions
What is clinical trial NCT05044195 about?
NCT05044195 is a clinical study titled "A Clinical Study to Evaluate the Immunogenicity and Safety of an Adjuvanted Quadrivalent Influenza Vaccine Compared With a Licensed Quadrivalent Vaccine in Adults 50 to 64 Years of Age". This Phase 3 study is a randomized, observer-blind immunogenicity and safety study of aQIV (an MF59-adjuvanted quadrivalent influenza vaccine) compared with a licensed quadrivalent influenza vaccine in adults 50 to 64 years of age.
What is the current status of trial NCT05044195?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,044 participants. The study started on 2021-09-30. Estimated completion is 2022-09-09.
What conditions does trial NCT05044195 study?
This clinical trial studies the following conditions: Influenza, Human.
What interventions are being tested in trial NCT05044195?
The interventions under investigation include: aQIV (BIOLOGICAL), Comparator QIV (BIOLOGICAL).
Who is sponsoring clinical trial NCT05044195?
This trial is sponsored by Seqirus, which has 25 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05044195 being conducted?
This trial has 20 study locations across Alabama, Arizona, Florida, Georgia, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Influenza, Human
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05044195's enrollment target sits among peer trials
2,044 5th of 18 higher than 14 of 18 other Influenza, Human trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Influenza, Human 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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