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NCT00873912 · ClinicalTrials.gov registry record · Phase 4
A Prospective Study to Evaluate the Safety of a New Monovalent Intranasal Influenza Vaccine
A Phase 4 study, sponsored by MedImmune.
- Completed
- Registry status
- Phase 4
- Development phase
- 300
- Enrollment target
NCT00873912: Completed Phase 4 study, sponsored by MedImmune.
NCT00873912 is a Phase 4 study that has completed, run by MedImmune. The registered enrollment target is 300 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
NCT00873912, a Phase 4 study, has completed, sponsored by MedImmune.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 300 participants
- Enrollment target
Study Summary
This prospective annual release study was designed to assess the safety of a monovalent influenza virus vaccine using a new strain recommended for the 2009-2010 influenza season not previously contained in the trivalent intranasal FluMist vaccine. Three hundred healthy adults received a single dose of vaccine or placebo and were followed for 180 days.
Primary Outcome
The percentage of subjects with fever was compared between the two treatment groups based on the upper limit of the two-sided 95% exact confidence interval (CI) for the rate difference (monovalent vaccine minus placebo). The upper limit of the two-sided 95% CI was evaluated against the pre-specified equivalence criterion of 5 percentage points which corresponded to the following hypotheses: - H0 (null): rate difference ≥ 5 percentage points, - HA (alternative): rate difference \< 5 percentage po
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Monovalent influenza virus vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2009-05 |
| Est. Completion | 2009-12 |
| Phase | Phase 4 |
What the finished NCT00873912 record still lists
NCT00873912 is an interventional study that assigns participants to a tested intervention. The registered 300 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.
NCT00873912 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00873912 about?
NCT00873912 is a clinical study titled "A Prospective Study to Evaluate the Safety of a New Monovalent Intranasal Influenza Vaccine". This prospective annual release study was designed to assess the safety of a monovalent influenza virus vaccine using a new strain recommended for the 2009-2010 influenza season not previously contained in the trivalent intranasal FluMist vaccine. Three hundred healthy adults received a single dose ...
What is the current status of trial NCT00873912?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 300 participants. The study started on 2009-05. Estimated completion is 2009-12.
What interventions are being tested in trial NCT00873912?
The interventions under investigation include: Placebo (BIOLOGICAL), Monovalent influenza virus vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00873912?
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 NCT00873912's enrollment target sits among peer trials
300 269th of 2000 higher than 1,709 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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