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NCT01594320 · ClinicalTrials.gov registry record · Phase 1
A/H5N1 Virus-Like Particle Antigen Dose Ranging Study With Adjuvant 1
A Phase 1 study, sponsored by Novavax.
- Completed
- Registry status
- Phase 1
- Development phase
- 333
- Enrollment target
NCT01594320: Completed Phase 1 study, sponsored by Novavax.
NCT01594320 is a Phase 1 study that has completed, run by Novavax. The registered enrollment target is 333 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (455% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01594320, a Phase 1 study, has completed, sponsored by Novavax.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 333 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the immunogenicity and safety profile of the Avian flu vaccine with and without adjuvant 1 in healthy, young adults. The study is divided down into Parts A1, A2 and B. Groups within each Part will receive two doses of the assigned test article on Study Days 0 and 21. There will be a Safety Monitoring Committee assessment following Day 7 for each part, prior to allowing vaccination of subjects in subsequent Parts of the study.
Interventions
- BIOLOGICAL Monovalent Avian Influenza VLP (H5N1)
- BIOLOGICAL Monovalent Avian Influenza VLP (H5N1); Adjuvant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 333 participants |
| Start Date | 2012-04 |
| Est. Completion | 2013-08 |
| Phase | Phase 1 |
What the finished NCT01594320 record still lists
NCT01594320 is an interventional study that assigns participants to a tested intervention. The registered 333 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 (455% higher).
The record links to 0 conditions, and to 2 interventions - of which Monovalent Avian Influenza VLP (H5N1) is the first listed.
NCT01594320 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01594320 about?
NCT01594320 is a clinical study titled "A/H5N1 Virus-Like Particle Antigen Dose Ranging Study With Adjuvant 1". The purpose of this study is to evaluate the immunogenicity and safety profile of the Avian flu vaccine with and without adjuvant 1 in healthy, young adults. The study is divided down into Parts A1, A2 and B. Groups within each Part will receive two doses of the assigned test article on Study Days 0...
What is the current status of trial NCT01594320?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 333 participants. The study started on 2012-04. Estimated completion is 2013-08.
What interventions are being tested in trial NCT01594320?
The interventions under investigation include: Monovalent Avian Influenza VLP (H5N1) (BIOLOGICAL), Monovalent Avian Influenza VLP (H5N1); Adjuvant (BIOLOGICAL).
Who is sponsoring clinical trial NCT01594320?
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 NCT01594320's enrollment target sits among peer trials
333 108th of 2000 higher than 1,893 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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