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NCT05616546 · ClinicalTrials.gov registry record · Phase 4
Bone Marrow and Peripheral Blood Immune Responses Study
A Phase 4 study of Influenza, sponsored by Emory University.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 90
- Enrollment target
- 1
- Study location
NCT05616546: Recruiting Phase 4 study of Influenza, sponsored by Emory University.
NCT05616546 is a Phase 4 study of Influenza that is actively recruiting participants, run by Emory University. The registered enrollment target is 90 participants, below the 36,803-participant average among 156 other Influenza trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05616546, a Phase 4 study of Influenza, is actively recruiting participants, sponsored by Emory University.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 90 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate the immune response of the killed flu vaccine in healthy subjects. Participants in this study are considered to be healthy volunteers. Influenza ("Flu") infection carries a risk of serious illness. This is an open label and single arm observational study designed to assess the humoral response to influenza vaccination and the longevity of humoral immunity to influenza vaccination in healthy adults. Enrolled subjects will receive licensed seasonal inactivated influenza vaccine (administered as a part of the study). Participants will donate serial samples of blood and bone marrow aspirate for immunology monitoring. Repeated measurements of humoral immunity will be obtained at 7 days, 28 days, 90 days and at one year post vaccination to assess the magnitude, clonal diversity and persistence of B-cell responses to influenza vaccination.
Primary Outcome
Blood samples will be drawn, labeled, and logged at the Georgia Clinical \& Translational Science Alliance (CTSA) of Emory University by a skilled clinical research nurse or phlebotomist. Blood samples will be drawn and stored in 8ml CPT tubes. These samples will be maintained at room temperature until they are transported to the laboratory. Clonal diversity of B-Cell response to Influenza in blood will be measured on study days 0, 7, 28, 90, and 365, and compared for changes.
Conditions Studied
Interventions
- BIOLOGICAL Influenza Vaccine
Study Locations (1)
Georgia
- Emory University Hospital - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2023-10-16 |
| Est. Completion | 2029-12 |
| Phase | Phase 4 |
What NCT05616546 shows while recruiting
NCT05616546 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 36,803-participant average among 156 other Influenza trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Influenza appearing as the primary indexed condition, and to 1 intervention - of which Influenza Vaccine is the first listed.
NCT05616546 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT05616546 about?
NCT05616546 is a clinical study titled "Bone Marrow and Peripheral Blood Immune Responses Study". The purpose of this study is to evaluate the immune response of the killed flu vaccine in healthy subjects. Participants in this study are considered to be healthy volunteers. Influenza ("Flu") infection carries a risk of serious illness. This is an open label and single arm observational study des...
What is the current status of trial NCT05616546?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 90 participants. The study started on 2023-10-16. Estimated completion is 2029-12.
What conditions does trial NCT05616546 study?
This clinical trial studies the following conditions: Influenza.
What interventions are being tested in trial NCT05616546?
The interventions under investigation include: Influenza Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT05616546?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05616546 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Influenza
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 NCT05616546's enrollment target sits among peer trials
90 105th of 156 higher than 51 of 156 other Influenza trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Influenza 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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-
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