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NCT03158038 · ClinicalTrials.gov registry record · Phase 4
Study to Evaluate the Safety of 1 New 6:2 Influenza Virus Reassortant in Adults for the 2017-2018 Season
A Phase 4 study of Healthy and Influenza, sponsored by MedImmune.
- Completed
- Registry status
- Phase 4
- Development phase
- 300
- Enrollment target
- 2
- Study locations
NCT03158038: Completed Phase 4 study of Healthy and Influenza, sponsored by MedImmune.
NCT03158038 is a Phase 4 study of Healthy and Influenza that has completed, run by MedImmune. The registered enrollment target is 300 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (54% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03158038, a Phase 4 study of Healthy and Influenza, has completed, sponsored by MedImmune.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 300 participants
- Enrollment target
- 2
- Study locations
Study Summary
This prospective annual release study is designed to evaluate the safety of 1 new influenza virus vaccine strain to be included in FluMist Quadrivalent for the 2017-2018 influenza season.
Primary Outcome
Percentage of participants with fever defined as oral temperature \>=101 degrees F were reported.
Interventions
- OTHER Placebo
- BIOLOGICAL Monovalent Influenza Vaccine
Study Locations (2)
Georgia
- Research Site - Stockbridge
Oregon
- Research Site - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2017-05-30 |
| Est. Completion | 2017-12-14 |
| Phase | Phase 4 |
What the finished NCT03158038 record still lists
NCT03158038 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (54% lower).
The record links to 2 conditions, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03158038 reports a single indexed study location in Georgia, Oregon.
Frequently Asked Questions
What is clinical trial NCT03158038 about?
NCT03158038 is a clinical study titled "Study to Evaluate the Safety of 1 New 6:2 Influenza Virus Reassortant in Adults for the 2017-2018 Season". This prospective annual release study is designed to evaluate the safety of 1 new influenza virus vaccine strain to be included in FluMist Quadrivalent for the 2017-2018 influenza season.
What is the current status of trial NCT03158038?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 300 participants. The study started on 2017-05-30. Estimated completion is 2017-12-14.
What conditions does trial NCT03158038 study?
This clinical trial studies the following conditions: Healthy, Influenza.
What interventions are being tested in trial NCT03158038?
The interventions under investigation include: Placebo (OTHER), Monovalent Influenza Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT03158038?
This trial is sponsored by MedImmune, which has 210 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03158038 being conducted?
This trial has 2 study locations across Georgia, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03158038's enrollment target sits among peer trials
300 77th of 1090 higher than 1,004 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy 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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