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NCT00860067 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Immunogenicity of Quadrivalent LAIV in Adults 18 to 49 Years of Age
A Phase 2 study of Healthy or Stable Underlying Chronic Medical Condition, sponsored by MedImmune.
- Completed
- Registry status
- Phase 2
- Development phase
- 1,800
- Enrollment target
- 18
- Study locations
NCT00860067: Completed Phase 2 study of Healthy or Stable Underlying Chronic Medical Condition, sponsored by MedImmune.
NCT00860067 is a Phase 2 study of Healthy or Stable Underlying Chronic Medical Condition that has completed, run by MedImmune. The registered enrollment target is 1,800 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (1253% higher). The trial reports 18 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00860067, a Phase 2 study of Healthy or Stable Underlying Chronic Medical Condition, has completed, sponsored by MedImmune.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1,800 participants
- Enrollment target
- 18
- Study locations
Study Summary
The objective of this study was to show that quadrivalent live attenuated influenza vaccine (Q/LAIV; MEDI3250) produced antibody levels similar to those produced by the commercial vaccine, FluMist.
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.
Conditions Studied
Interventions
- BIOLOGICAL Q/LAIV (MEDI3250)
- BIOLOGICAL FluMist/B/Yamagata
- BIOLOGICAL FluMist/B/Victoria
Study Locations (18)
Florida
- University Clinical Research-Deland, LLC - DeLand
- Pharmax Research Clinic, Inc - Miami
- University Clinical Research, Inc - Pembroke Pines
- Miami Research Associates - South Miami
California
- Benchmark Research - Sacramento
- California Research Foundation - San Diego
- Benchmark Research - San Francisco
Missouri
- The Center for Pharmaceutical Research, PC - Kansas City
- Sundance Clinical Research - St Louis
Texas
- Benchmark Research - Austin
- Benchmark Research - Fort Worth
Georgia
- Clinical Research Atlanta - Stockbridge
Kansas
- Vince and Associates Clinical Research - Overland Park
Kentucky
- Kentucky Pediatric / Adult Research - Bardstown
Nebraska
- Meridian Clinical Research, LLC - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,800 participants |
| Start Date | 2009-03 |
| Est. Completion | 2009-10 |
| Phase | Phase 2 |
What the finished NCT00860067 record still lists
NCT00860067 is an interventional study that assigns participants to a tested intervention. Its 1,800 participants enrollment target places it among the larger protocols in the corpus, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (1253% higher).
The record links to 1 condition, with Healthy or Stable Underlying Chronic Medical Condition appearing as the primary indexed condition, and to 3 interventions - of which Q/LAIV (MEDI3250) is the first listed.
NCT00860067 lists 18 locations in 11 states (Florida, California, Missouri).
Frequently Asked Questions
What is clinical trial NCT00860067 about?
NCT00860067 is a clinical study titled "A Study to Evaluate the Immunogenicity of Quadrivalent LAIV in Adults 18 to 49 Years of Age". The objective of this study was to show that quadrivalent live attenuated influenza vaccine (Q/LAIV; MEDI3250) produced antibody levels similar to those produced by the commercial vaccine, FluMist.
What is the current status of trial NCT00860067?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,800 participants. The study started on 2009-03. Estimated completion is 2009-10.
What conditions does trial NCT00860067 study?
This clinical trial studies the following conditions: Healthy or Stable Underlying Chronic Medical Condition.
What interventions are being tested in trial NCT00860067?
The interventions under investigation include: Q/LAIV (MEDI3250) (BIOLOGICAL), FluMist/B/Yamagata (BIOLOGICAL), FluMist/B/Victoria (BIOLOGICAL).
Who is sponsoring clinical trial NCT00860067?
This trial is sponsored by MedImmune, which has 210 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00860067 being conducted?
This trial has 18 study locations across California, Florida, Georgia, Kansas, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00860067's enrollment target sits among peer trials
1,800 10th of 2000 higher than 1,991 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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