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NCT01579916 · ClinicalTrials.gov registry record · Phase 4
A Study to Evaluate the Safety of 3 New 6:2 Influenza Virus Reassortants in Adults
A Phase 4 study, sponsored by MedImmune.
- Completed
- Registry status
- Phase 4
- Development phase
- 303
- Enrollment target
NCT01579916: Completed Phase 4 study, sponsored by MedImmune.
NCT01579916 is a Phase 4 study that has completed, run by MedImmune. The registered enrollment target is 303 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01579916, a Phase 4 study, has completed, sponsored by MedImmune.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 303 participants
- Enrollment target
Study Summary
This prospective annual release study was designed to assess the safety of a trivalent influenza virus vaccine using two new strains recommended for the 2012-2013 influenza season not previously contained in the trivalent intranasal FluMist vaccine. Three hundred healthy adults will receive a single dose of vaccine or placebo and will be followed for 180 days after study vaccination.
Primary Outcome
A comparison of the rate of fever, defined as oral temperature greater than or equal to 101 degrees Fahrenheit, reported during the 7 days post administration of investigational product between the trivalent influenza virus vaccine and placebo groups.
Interventions
- OTHER Placebo
- BIOLOGICAL Trivalent Influenza Virus Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 303 participants |
| Start Date | 2012-05 |
| Est. Completion | 2012-11 |
| Phase | Phase 4 |
What the finished NCT01579916 record still lists
NCT01579916 is an interventional study that assigns participants to a tested intervention. The registered 303 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 (42% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01579916 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01579916 about?
NCT01579916 is a clinical study titled "A Study to Evaluate the Safety of 3 New 6:2 Influenza Virus Reassortants in Adults". This prospective annual release study was designed to assess the safety of a trivalent influenza virus vaccine using two new strains recommended for the 2012-2013 influenza season not previously contained in the trivalent intranasal FluMist vaccine. Three hundred healthy adults will receive a singl...
What is the current status of trial NCT01579916?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 303 participants. The study started on 2012-05. Estimated completion is 2012-11.
What interventions are being tested in trial NCT01579916?
The interventions under investigation include: Placebo (OTHER), Trivalent Influenza Virus Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01579916?
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 NCT01579916's enrollment target sits among peer trials
303 266th of 2000 higher than 1,735 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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