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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 is a Phase 1 study that has completed, run by Novavax. The registered enrollment target is 230 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00519389
The ClinicalTrials.gov registry entry for NCT00519389 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 230 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novavax, which has 31 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00519389 reports 0 study locations.
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.
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