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NCT02680002 · ClinicalTrials.gov registry record · Phase 2
Assess the Safety & Immunogenicity of Stored Inactivated Influenza H5N1 Virus Vaccine Given With & Without Stored MF59 Adjuvant
A Phase 2 study, sponsored by Biomedical Advanced Research and Development Authority.
- Completed
- Registry status
- Phase 2
- Development phase
- 422
- Enrollment target
NCT02680002: Completed Phase 2 study, sponsored by Biomedical Advanced Research and Development Authority.
NCT02680002 is a Phase 2 study that has completed, run by Biomedical Advanced Research and Development Authority. The registered enrollment target is 422 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (217% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02680002, a Phase 2 study, has completed, sponsored by Biomedical Advanced Research and Development Authority.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 422 participants
- Enrollment target
Study Summary
The main purpose of this study is to assess the usability of long-term stored H5N1 antigen and adjuvant. The study is designed to assist in stockpile management by assessing the safety, reactogenicity, and immunogenicity long-term stored influenza A/Vietnam/H5N1 vaccine when administered with or without MF59® adjuvant.
Primary Outcome
Occurence of mild, moderate, or severe solicited local symptoms during the 7 days (Days 0 to 7) following Dose 1
Interventions
- BIOLOGICAL 7.5 mcg H5N1 (stored as monobulk)
- BIOLOGICAL 15 mcg H5N1 (stored as monobulk)
- BIOLOGICAL 90 mcg H5N1 (stored as monobulk)
- BIOLOGICAL 90 mcg H5N1 (stored in vials)
- OTHER MF59
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 422 participants |
| Start Date | 2016-03 |
| Est. Completion | 2017-03-31 |
| Phase | Phase 2 |
What the finished NCT02680002 record still lists
NCT02680002 is an interventional study that assigns participants to a tested intervention. The registered 422 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (217% higher).
The record links to 0 conditions, and to 5 interventions - of which 7.5 mcg H5N1 (stored as monobulk) is the first listed.
NCT02680002 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02680002 about?
NCT02680002 is a clinical study titled "Assess the Safety & Immunogenicity of Stored Inactivated Influenza H5N1 Virus Vaccine Given With & Without Stored MF59 Adjuvant". The main purpose of this study is to assess the usability of long-term stored H5N1 antigen and adjuvant. The study is designed to assist in stockpile management by assessing the safety, reactogenicity, and immunogenicity long-term stored influenza A/Vietnam/H5N1 vaccine when administered with or wit...
What is the current status of trial NCT02680002?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 422 participants. The study started on 2016-03. Estimated completion is 2017-03-31.
What interventions are being tested in trial NCT02680002?
The interventions under investigation include: 7.5 mcg H5N1 (stored as monobulk) (BIOLOGICAL), 15 mcg H5N1 (stored as monobulk) (BIOLOGICAL), 90 mcg H5N1 (stored as monobulk) (BIOLOGICAL), 90 mcg H5N1 (stored in vials) (BIOLOGICAL), MF59 (OTHER).
Who is sponsoring clinical trial NCT02680002?
This trial is sponsored by Biomedical Advanced Research and Development Authority, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02680002's enrollment target sits among peer trials
422 91st of 2000 higher than 1,910 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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