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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 is a Phase 2 study that has completed, run by Biomedical Advanced Research and Development Authority. The registered enrollment target is 422 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02680002
The ClinicalTrials.gov registry entry for NCT02680002 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 422 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biomedical Advanced Research and Development Authority, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which 7.5 mcg H5N1 (stored as monobulk) is the first listed.
NCT02680002 reports 0 study locations.
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.
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