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NCT03143101 · ClinicalTrials.gov registry record · Phase 4
Evaluate the Shedding and Immunogencity of Different Formulations of FluMist in Children 24 to <48 Months of Age
A Phase 4 study, sponsored by MedImmune.
- Completed
- Registry status
- Phase 4
- Development phase
- 200
- Enrollment target
NCT03143101: Completed Phase 4 study, sponsored by MedImmune.
NCT03143101 is a Phase 4 study that has completed, run by MedImmune. The registered enrollment target is 200 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03143101, a Phase 4 study, has completed, sponsored by MedImmune.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 200 participants
- Enrollment target
Study Summary
This study is being conducted to compare the immunogenicity, safety, and viral shedding of a new A/H1N1 strain that will be incorporated into the FluMist quadrivalent formulation for the 2017-2018 influenza season with the previous A/H1N1 strain that was included in the vaccine in the 2015-2016 influenza season.
Primary Outcome
Seroconversion rate is defined as at least (\>=) 4-fold rise from baseline in A/H1N1 HAI antibody titer. Percentage of participants with \>= 4-fold rise in A/H1N1 HAI antibody titer at Day 28 is reported. Comparative statistical analysis was planned only for 'FluMist Quadrivalent (2015-2016)' and 'FluMist Quadrivalent (2017-2018)' arms.
Interventions
- BIOLOGICAL FluMist trivalent (2015-2016)
- BIOLOGICAL FluMist Quadrivalent (2015-2016)
- BIOLOGICAL FluMist Quadrivalent (2017-2018)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2017-05-08 |
| Est. Completion | 2017-09-29 |
| Phase | Phase 4 |
What the finished NCT03143101 record still lists
NCT03143101 is an interventional study that assigns participants to a tested intervention. The registered 200 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 (61% lower).
The record links to 0 conditions, and to 3 interventions - of which FluMist trivalent (2015-2016) is the first listed.
NCT03143101 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03143101 about?
NCT03143101 is a clinical study titled "Evaluate the Shedding and Immunogencity of Different Formulations of FluMist in Children 24 to <48 Months of Age". This study is being conducted to compare the immunogenicity, safety, and viral shedding of a new A/H1N1 strain that will be incorporated into the FluMist quadrivalent formulation for the 2017-2018 influenza season with the previous A/H1N1 strain that was included in the vaccine in the 2015-2016 infl...
What is the current status of trial NCT03143101?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 200 participants. The study started on 2017-05-08. Estimated completion is 2017-09-29.
What interventions are being tested in trial NCT03143101?
The interventions under investigation include: FluMist trivalent (2015-2016) (BIOLOGICAL), FluMist Quadrivalent (2015-2016) (BIOLOGICAL), FluMist Quadrivalent (2017-2018) (BIOLOGICAL).
Who is sponsoring clinical trial NCT03143101?
This trial is sponsored by MedImmune, which has 210 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03143101's enrollment target sits among peer trials
200 407th of 2000 higher than 1,556 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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