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NCT05654441 · ClinicalTrials.gov registry record · Phase 4
Body and Social Behavior
A Phase 4 study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 4
- Development phase
- 104
- Enrollment target
NCT05654441: Completed Phase 4 study, sponsored by University of North Carolina, Chapel Hill.
NCT05654441 is a Phase 4 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 104 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05654441, a Phase 4 study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 104 participants
- Enrollment target
Study Summary
This randomized, double-blind, placebo-controlled study of the influenza vaccine will shed important light on how the immune system responds to different positive and negative social experiences. Building on the nuanced animal literature showing that, while animals exposed to an inflammatory challenge show reductions in social exploration consistent with the sickness behavior of social withdrawal, they actually show increases in social engagement behavior during interactions with a cage mate or pair-bonded animal. The present study will examine if a mild inflammatory challenge (receipt of the influenza vaccine) leads to change in actual social behavior in interactions, specifically toward a stranger and separately, toward a close friend. This study will also build on foundational animal research showing that an inflammatory challenge leads to social defeat behaviors in animals.
Primary Outcome
The investigators will examine levels of IL-6 measured in plasma 24-hours following the vaccine.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Influenza vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2022-10-17 |
| Est. Completion | 2023-12-15 |
| Phase | Phase 4 |
What the finished NCT05654441 record still lists
NCT05654441 is an interventional study that assigns participants to a tested intervention. The registered 104 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05654441 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05654441 about?
NCT05654441 is a clinical study titled "Body and Social Behavior". This randomized, double-blind, placebo-controlled study of the influenza vaccine will shed important light on how the immune system responds to different positive and negative social experiences. Building on the nuanced animal literature showing that, while animals exposed to an inflammatory challen...
What is the current status of trial NCT05654441?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 104 participants. The study started on 2022-10-17. Estimated completion is 2023-12-15.
What interventions are being tested in trial NCT05654441?
The interventions under investigation include: Placebo (BIOLOGICAL), Influenza vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT05654441?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05654441's enrollment target sits among peer trials
104 754th of 2000 higher than 1,241 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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