CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 104 enrolled
Drug / intervention
Influenza vaccine +1 morebiological
Likely dose
Influenza vaccine 0.5 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05654441
NCT05654441Phase 4Completed

Low-grade Inflammatory Challenge and Social Behavior

University of North Carolina, Chapel Hill·interventional·Posted Dec 16, 2022·Updated Nov 27, 2024

In Brief

A Phase 4 clinical trial evaluating Influenza vaccine and Placebo for Psychology, Social and 3 related conditions. Completed, enrolled 104 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
2023202420252026
First PostedDec 16, 2022
Enrollment StartOct 17, 2022
Primary CompletionDec 15, 2023
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 3.5 years ago

Interventions

Influenza vaccinebiological

0.5 mL single-dose injection

Placebobiological

0.5 mL single-dose injection with no therapeutic effect