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NCT01596725 · ClinicalTrials.gov registry record · Phase 1
A/H5N1 Virus-Like Particle Antigen Dose Ranging Study With Adjuvant 2
A Phase 1 study, sponsored by Novavax.
- Completed
- Registry status
- Phase 1
- Development phase
- 333
- Enrollment target
NCT01596725 is a Phase 1 study that has completed, run by Novavax. The registered enrollment target is 333 participants.
The verdict
NCT01596725, 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 2 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 | 2012-05 |
| Est. Completion | 2013-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01596725
The ClinicalTrials.gov registry entry for NCT01596725 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 333 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 Monovalent Avian Influenza VLP (H5N1) is the first listed.
NCT01596725 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01596725 about?
NCT01596725 is a clinical study titled "A/H5N1 Virus-Like Particle Antigen Dose Ranging Study With Adjuvant 2". The purpose of this study is to evaluate the immunogenicity and safety profile of the Avian flu vaccine with and without adjuvant 2 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 NCT01596725?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 333 participants. The study started on 2012-05. Estimated completion is 2013-08.
What interventions are being tested in trial NCT01596725?
The interventions under investigation include: Monovalent Avian Influenza VLP (H5N1) (BIOLOGICAL), Monovalent Avian Influenza VLP (H5N1); Adjuvant (BIOLOGICAL).
Who is sponsoring clinical trial NCT01596725?
This trial is sponsored by Novavax, which has 31 total clinical trials registered on ClinicalTrials.gov.
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