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NCT01091246 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Immunogenicity of Quadrivalent Live Attenuated Influenza Vaccine (LAIV) in Children
A Phase 3 study, sponsored by MedImmune.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,312
- Enrollment target
NCT01091246: Completed Phase 3 study, sponsored by MedImmune.
NCT01091246 is a Phase 3 study that has completed, run by MedImmune. The registered enrollment target is 2,312 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (199% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01091246, a Phase 3 study, has completed, sponsored by MedImmune.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,312 participants
- Enrollment target
Study Summary
The primary objective of this study is to demonstrate the immunologic noninferiority of Q/LAIV to FluMist in children 2 to 17 years of age.
Primary Outcome
Noninferior immune response was defined as having the upper bound of the 2-sided 95% confidence intervals (CIs) for the HAI antibody GMT ratio (FluMist comparator divided by Q/LAIV) ≤ 1.5 for each of the 4 strains. .
Interventions
- BIOLOGICAL Q/LAIV (MEDI3250)
- BIOLOGICAL FluMist/B/Yamagata
- BIOLOGICAL FluMist/B/Victoria
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,312 participants |
| Start Date | 2010-03 |
| Est. Completion | 2010-12 |
| Phase | Phase 3 |
What the finished NCT01091246 record still lists
NCT01091246 is an interventional study that assigns participants to a tested intervention. Its 2,312 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 (199% higher).
The record links to 0 conditions, and to 3 interventions - of which Q/LAIV (MEDI3250) is the first listed.
NCT01091246 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01091246 about?
NCT01091246 is a clinical study titled "A Study to Evaluate the Immunogenicity of Quadrivalent Live Attenuated Influenza Vaccine (LAIV) in Children". The primary objective of this study is to demonstrate the immunologic noninferiority of Q/LAIV to FluMist in children 2 to 17 years of age.
What is the current status of trial NCT01091246?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,312 participants. The study started on 2010-03. Estimated completion is 2010-12.
What interventions are being tested in trial NCT01091246?
The interventions under investigation include: Q/LAIV (MEDI3250) (BIOLOGICAL), FluMist/B/Yamagata (BIOLOGICAL), FluMist/B/Victoria (BIOLOGICAL).
Who is sponsoring clinical trial NCT01091246?
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 NCT01091246's enrollment target sits among peer trials
2,312 94th of 2000 higher than 1,907 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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