CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 33 enrolled
Drug / intervention
IIV Flu Vaccine +3 moredrug
Likely dose
Not stated in 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/NCT02154061
NCT02154061N/ACompleted

Systems Biology of Inactivated Influenza Vaccine (IIV) in Healthy Adults With or Without Use of Broad Spectrum Antibiotics

Emory University·interventional·Posted Jun 3, 2014·Updated Aug 15, 2018

In Brief

A clinical study evaluating IIV Flu Vaccine, Metronidazole, and 2 other interventions for Influenza. Completed, enrolled 33 participants across 1 site.

Detailed Summary

The purpose of the study is to better understand how the use of antibiotics changes micro-organisms in the intestines. The change to micro-organisms in the intestines may change the body's vaccine immune response and alter the effectiveness of the IIV (seasonal flu) vaccine. In particular, the investigators will be looking at certain markers in blood after vaccination with IIV (seasonal flu vaccine) with or without the use of antibiotics before vaccination. There will be two randomized groups. Group A will start taking antibiotic by mouth 3 days prior to vaccination and continue taking antibiotics the day of vaccination and one day after vaccination for a total of 5 days. Group B will only receive the IIV (seasonal flu vaccine) and will not take any antibiotics. The investigators hope to enroll 50 subjects at Emory.

Study Details

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

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 3, 2014
Enrollment StartApr 1, 2015
Primary CompletionMay 26, 2017
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 12.1 years ago

Interventions

IIV Flu Vaccinedrug

This is an FDA approved and tested Inactivated Flu Vaccine.

Metronidazoledrug

This is a standard antibiotic

Neomycindrug

This is a standard antibiotic.

Vancomycindrug

This is a standard antibiotic.