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NCT04074928 · ClinicalTrials.gov registry record · Phase 3
Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects
A Phase 3 study, sponsored by Seqirus.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,414
- Enrollment target
NCT04074928: Completed Phase 3 study, sponsored by Seqirus.
NCT04074928 is a Phase 3 study that has completed, run by Seqirus. The registered enrollment target is 2,414 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (213% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04074928, a Phase 3 study, has completed, sponsored by Seqirus.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,414 participants
- Enrollment target
Study Summary
This phase 3 clinical study is a randomized, observer-blind, comparator-controlled, multicenter study of QIVc versus a US-licensed comparator QIV in children 6 months through 47 months of age. The purpose of this study is to demonstrate that vaccination with QIVc elicits an immune response that is noninferior to that of a US-licensed comparator QIV containing the same virus strains, in children 6 months through 47 months of age.
Primary Outcome
The GMT ratio is defined as the geometric mean of the postvaccination (28 days after last vaccination) HAI titer for the Comparator QIV divided by the geometric mean of the postvaccination HAI titer for QIVc.
Interventions
- BIOLOGICAL Comparator QIV
- BIOLOGICAL QIVc
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,414 participants |
| Start Date | 2019-09-06 |
| Est. Completion | 2020-09-03 |
| Phase | Phase 3 |
What the finished NCT04074928 record still lists
NCT04074928 is an interventional study that assigns participants to a tested intervention. Its 2,414 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (213% higher).
The record links to 0 conditions, and to 2 interventions - of which Comparator QIV is the first listed.
NCT04074928 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04074928 about?
NCT04074928 is a clinical study titled "Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects". This phase 3 clinical study is a randomized, observer-blind, comparator-controlled, multicenter study of QIVc versus a US-licensed comparator QIV in children 6 months through 47 months of age. The purpose of this study is to demonstrate that vaccination with QIVc elicits an immune response that is n...
What is the current status of trial NCT04074928?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,414 participants. The study started on 2019-09-06. Estimated completion is 2020-09-03.
What interventions are being tested in trial NCT04074928?
The interventions under investigation include: Comparator QIV (BIOLOGICAL), QIVc (BIOLOGICAL).
Who is sponsoring clinical trial NCT04074928?
This trial is sponsored by Seqirus, which has 25 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04074928's enrollment target sits among peer trials
2,414 89th of 2000 higher than 1,912 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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