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NCT02154061 · ClinicalTrials.gov registry record · NA
Systems Biology of Flu Vaccine in Healthy Adults With and Without the Use of Antibiotics
A NA study, sponsored by Emory University.
- Completed
- Registry status
- NA
- Development phase
- 33
- Enrollment target
NCT02154061: Completed NA study, sponsored by Emory University.
NCT02154061 is a NA study that has completed, run by Emory University. The registered enrollment target is 33 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02154061, a NA study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- NA
- Development phase
- 33 participants
- Enrollment target
Study 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.
Primary Outcome
Number of participants with four fold rise in HAI titers or HAI 1:40 and above in each group at D30 will be recorded based on immunologic testing of blood samples
Interventions
- DRUG Vancomycin
- DRUG Metronidazole
- DRUG Neomycin
- DRUG IIV Flu Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2015-04 |
| Est. Completion | 2017-05-26 |
| Phase | NA |
What the finished NCT02154061 record still lists
NCT02154061 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 4 interventions - of which Vancomycin is the first listed.
NCT02154061 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02154061 about?
NCT02154061 is a clinical study titled "Systems Biology of Flu Vaccine in Healthy Adults With and Without the Use of Antibiotics". 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 inve...
What is the current status of trial NCT02154061?
This trial is currently completed. It is a NA study. The enrollment target is 33 participants. The study started on 2015-04. Estimated completion is 2017-05-26.
What interventions are being tested in trial NCT02154061?
The interventions under investigation include: Vancomycin (DRUG), Metronidazole (DRUG), Neomycin (DRUG), IIV Flu Vaccine (DRUG).
Who is sponsoring clinical trial NCT02154061?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02154061's enrollment target sits among peer trials
33 1574th of 2000 higher than 423 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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