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NCT04164212 · ClinicalTrials.gov registry record · Phase 4
Live Attenuated Influenza Vaccine as a Nasal Model for Influenza Infection
A Phase 4 study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- Phase 4
- Development phase
- 33
- Enrollment target
NCT04164212: Completed Phase 4 study, sponsored by University of Alabama at Birmingham.
NCT04164212 is a Phase 4 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 33 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04164212, a Phase 4 study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 33 participants
- Enrollment target
Study Summary
The purpose of this study is to develop a nasal model for influenza infection using the live attenuated influenza vaccine (LAIV). The investigators will administer LAIV to healthy adult volunteers in order to simulate influenza infection, and obtain nasal specimens to measure influenza virus and inflammatory/immune responses. In a subset of participants, cystic fibrosis transmembrane conductance regulator (CFTR) function will also be evaluated via measurement of nasal potential difference (NPD)
Primary Outcome
virus replication will be measured using RT-PCR and reported as genomic units, from samples obtained from nasal washing and nasal oropharyngeal swabs
Interventions
- DRUG Flumist Quadrivalent Nasal Product
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2020-09-01 |
| Est. Completion | 2026-01-22 |
| Phase | Phase 4 |
What the finished NCT04164212 record still lists
NCT04164212 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 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which Flumist Quadrivalent Nasal Product is the first listed.
NCT04164212 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04164212 about?
NCT04164212 is a clinical study titled "Live Attenuated Influenza Vaccine as a Nasal Model for Influenza Infection". The purpose of this study is to develop a nasal model for influenza infection using the live attenuated influenza vaccine (LAIV). The investigators will administer LAIV to healthy adult volunteers in order to simulate influenza infection, and obtain nasal specimens to measure influenza virus and inf...
What is the current status of trial NCT04164212?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 33 participants. The study started on 2020-09-01. Estimated completion is 2026-01-22.
What interventions are being tested in trial NCT04164212?
The interventions under investigation include: Flumist Quadrivalent Nasal Product (DRUG).
Who is sponsoring clinical trial NCT04164212?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04164212's enrollment target sits among peer trials
33 1528th of 2000 higher than 467 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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