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NCT00945893 · ClinicalTrials.gov registry record · Phase 4
A Study to Evaluate the Safety of H1N1 Monovalent Vaccine (MEDI3414) in Healthy Adults
A Phase 4 study, sponsored by MedImmune.
- Completed
- Registry status
- Phase 4
- Development phase
- 300
- Enrollment target
NCT00945893: Completed Phase 4 study, sponsored by MedImmune.
NCT00945893 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
NCT00945893, a Phase 4 study, has completed, sponsored by MedImmune.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 300 participants
- Enrollment target
Study Summary
The purpose of this study was to determine the safety and descriptive immunogenicity of the H1N1 influenza vaccine in healthy adults.
Primary Outcome
The number of participants with fever between the two treatment groups was compared based on the upper limit of the two-sided 95% exact confidence intervals (CIs) for the rate difference (Vaccine minus Placebo). The upper limit of the two-sided 95% CI was evaluated against the prespecified equivalence criterion of 10% which corresponded to the following hypotheses • H0 (null): rate difference ≥ 10% • HA (alternative): rate difference \< 10%
Interventions
- OTHER Placebo
- BIOLOGICAL MEDI3414 [Influenza A/H1N1 live attenuated, intranasal]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2009-08 |
| Est. Completion | 2010-03 |
| Phase | Phase 4 |
What the finished NCT00945893 record still lists
NCT00945893 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.
NCT00945893 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00945893 about?
NCT00945893 is a clinical study titled "A Study to Evaluate the Safety of H1N1 Monovalent Vaccine (MEDI3414) in Healthy Adults". The purpose of this study was to determine the safety and descriptive immunogenicity of the H1N1 influenza vaccine in healthy adults.
What is the current status of trial NCT00945893?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 300 participants. The study started on 2009-08. Estimated completion is 2010-03.
What interventions are being tested in trial NCT00945893?
The interventions under investigation include: Placebo (OTHER), MEDI3414 [Influenza A/H1N1 live attenuated, intranasal] (BIOLOGICAL).
Who is sponsoring clinical trial NCT00945893?
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 NCT00945893'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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