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NCT00519389 · ClinicalTrials.gov registry record · Phase 1
Safety, Reactogenicity and Immunogenicity of an H5N1 VLP
A Phase 1 study, sponsored by Novavax.
- Completed
- Registry status
- Phase 1
- Development phase
- 230
- Enrollment target
NCT00519389: Completed Phase 1 study, sponsored by Novavax.
NCT00519389 is a Phase 1 study that has completed, run by Novavax. The registered enrollment target is 230 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (283% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00519389, a Phase 1 study, has completed, sponsored by Novavax.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 230 participants
- Enrollment target
Study Summary
This is a Phase I/IIa randomized, double-blind, placebo-controlled study to evaluate the safety, reactogenicity, and immunogenicity of 3 potencies (dosages) of H5N1 VLP vaccine or placebo in healthy adults 18 to 40 years of age.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL H5N1 VLP Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 230 participants |
| Start Date | 2007-07 |
| Est. Completion | 2008-11 |
| Phase | Phase 1 |
What the finished NCT00519389 record still lists
NCT00519389 is an interventional study that assigns participants to a tested intervention. The registered 230 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (283% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00519389 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00519389 about?
NCT00519389 is a clinical study titled "Safety, Reactogenicity and Immunogenicity of an H5N1 VLP". This is a Phase I/IIa randomized, double-blind, placebo-controlled study to evaluate the safety, reactogenicity, and immunogenicity of 3 potencies (dosages) of H5N1 VLP vaccine or placebo in healthy adults 18 to 40 years of age.
What is the current status of trial NCT00519389?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 230 participants. The study started on 2007-07. Estimated completion is 2008-11.
What interventions are being tested in trial NCT00519389?
The interventions under investigation include: Placebo (BIOLOGICAL), H5N1 VLP Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00519389?
This trial is sponsored by Novavax, which has 31 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00519389's enrollment target sits among peer trials
230 219th of 2000 higher than 1,780 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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