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NCT06560151 · ClinicalTrials.gov registry record · Phase 2
Assess Safety and Immunogenicity of A/H5 Inactivated Monovalent Influenza Vaccines at Different Antigen Dose Levels Adjuvanted With AS03 or MF59
A Phase 2 study, sponsored by Biomedical Advanced Research and Development Authority.
- Completed
- Registry status
- Phase 2
- Development phase
- 1,380
- Enrollment target
NCT06560151 is a Phase 2 study that has completed, run by Biomedical Advanced Research and Development Authority. The registered enrollment target is 1,380 participants.
The verdict
NCT06560151, a Phase 2 study, has completed, sponsored by Biomedical Advanced Research and Development Authority.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1,380 participants
- Enrollment target
Study Summary
This BARDA-sponsored, randomized, double-blind, phase 2 study is designed to assess safety and immunogenicity of A/H5 inactivated monovalent influenza vaccines at different antigen dose levels adjuvanted with AS03 or MF59.
Interventions
- BIOLOGICAL 3.75 µg H5N8 antigen plus full dose AS03A
- BIOLOGICAL 7.5 µg H5N8 antigen plus full dose AS03A
- BIOLOGICAL 15 µg H5N8 antigen plus full dose AS03A
- BIOLOGICAL 3.75 µg H5N8 antigen plus half dose AS03A
- BIOLOGICAL 7.5 µg H5N8 antigen plus half dose AS03A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,380 participants |
| Start Date | 2024-08-21 |
| Est. Completion | 2025-06-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06560151
The ClinicalTrials.gov registry entry for NCT06560151 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 1,380 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 3.75 µg H5N8 antigen plus full dose AS03A is the first listed.
NCT06560151 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06560151 about?
NCT06560151 is a clinical study titled "Assess Safety and Immunogenicity of A/H5 Inactivated Monovalent Influenza Vaccines at Different Antigen Dose Levels Adjuvanted With AS03 or MF59". This BARDA-sponsored, randomized, double-blind, phase 2 study is designed to assess safety and immunogenicity of A/H5 inactivated monovalent influenza vaccines at different antigen dose levels adjuvanted with AS03 or MF59.
What is the current status of trial NCT06560151?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,380 participants. The study started on 2024-08-21. Estimated completion is 2025-06-11.
What interventions are being tested in trial NCT06560151?
The interventions under investigation include: 3.75 µg H5N8 antigen plus full dose AS03A (BIOLOGICAL), 7.5 µg H5N8 antigen plus full dose AS03A (BIOLOGICAL), 15 µg H5N8 antigen plus full dose AS03A (BIOLOGICAL), 3.75 µg H5N8 antigen plus half dose AS03A (BIOLOGICAL), 7.5 µg H5N8 antigen plus half dose AS03A (BIOLOGICAL).
Who is sponsoring clinical trial NCT06560151?
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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