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NCT03600428 · ClinicalTrials.gov registry record · Phase 4
Safety of LAIV4 in Children With Asthma
A Phase 4 study, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 152
- Enrollment target
NCT03600428: Completed Phase 4 study, sponsored by Vanderbilt University Medical Center.
NCT03600428 is a Phase 4 study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 152 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03600428, a Phase 4 study, has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 152 participants
- Enrollment target
Study Summary
This is a prospective randomized, open label clinical trial in approximately 300 children aged 5-11 years with a physician diagnosis of persistent asthma. Participants will be randomized 1:1 to receive either a single intranasal dose of licensed quadrivalent LAIV (LAIV4) or an intramuscular injection of quadrivalent IIV4 (IIV4).
Primary Outcome
For this study, asthma exacerbation will be defined as: any acute episode of progressively worsening shortness of breath (dyspnea), cough, wheezing, chest tightness, and/or respiratory distress during the 42 days (until day 43) after influenza vaccination for which the patient seeks unscheduled medical attention (e.g., healthcare provider office or Emergency Department visit or hospitalization) or receives a new prescription for systemic corticosteroids.
Interventions
- BIOLOGICAL Live Attenuated Influenza Vaccine (LAIV)
- BIOLOGICAL Inactivated Influenza Vaccine (IIV)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 152 participants |
| Start Date | 2018-10-15 |
| Est. Completion | 2020-03-20 |
| Phase | Phase 4 |
What the finished NCT03600428 record still lists
NCT03600428 is an interventional study that assigns participants to a tested intervention. The registered 152 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 (71% lower).
The record links to 0 conditions, and to 2 interventions - of which Live Attenuated Influenza Vaccine (LAIV) is the first listed.
NCT03600428 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03600428 about?
NCT03600428 is a clinical study titled "Safety of LAIV4 in Children With Asthma". This is a prospective randomized, open label clinical trial in approximately 300 children aged 5-11 years with a physician diagnosis of persistent asthma. Participants will be randomized 1:1 to receive either a single intranasal dose of licensed quadrivalent LAIV (LAIV4) or an intramuscular injectio...
What is the current status of trial NCT03600428?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 152 participants. The study started on 2018-10-15. Estimated completion is 2020-03-20.
What interventions are being tested in trial NCT03600428?
The interventions under investigation include: Live Attenuated Influenza Vaccine (LAIV) (BIOLOGICAL), Inactivated Influenza Vaccine (IIV) (BIOLOGICAL).
Who is sponsoring clinical trial NCT03600428?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03600428's enrollment target sits among peer trials
152 530th of 2000 higher than 1,468 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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