Assess Safety and Immunogenicity of A/H5 Inactivated Monovalent Influenza Vaccines at Different Antigen Dose Levels Adjuvanted With AS03 or MF59
Public ClinicalTrials.gov record NCT06560151. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Randomized, Double-Blind, Phase 2 Study to Assess Safety and Immunogenicity of A/H5 Inactivated Monovalent Influenza Vaccines at Different Antigen Dose Levels Adjuvanted With AS03® or MF59®
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06560151
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 1,380 participants
Conditions and interventions
Conditions
Interventions
- 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
- 15 µg H5N8 antigen plus half dose AS03A Biological
- 3.75 µg H5N8 antigen plus MF59 Biological
- 7.5 µg H5N8 antigen plus MF59 Biological
- 15 µg H5N8 antigen plus MF59 Biological
- 3.75 µg H5N1 antigen plus full dose AS03A Biological
- 7.5 µg H5N1 antigen plus full dose AS03A Biological
- 15 µg H5N1 antigen plus full dose AS03A Biological
- 3.75 µg H5N1 antigen plus MF59 Biological
- 7.5 µg H5N1 antigen plus MF59 Biological
- 15 µg H5N1 antigen plus MF59 Biological
Biological
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 21, 2024 (Actual)
- Primary completion
- Jan 16, 2025 (Actual)
- Completion
- Jun 11, 2025 (Actual)
- Last update posted
- Oct 1, 2026
2024 – 2025
United States locations
- U.S. sites
- 20
- U.S. states
- 11
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| DelRicht Research - Atlanta | Atlanta | Georgia | 30329 | — |
| Javara Research - Privia Medical Group Georgia | Savannah | Georgia | 31406 | — |
| Accellacare - Duly Health and Care - Oak Lawn | Oak Lawn | Illinois | 60453 | — |
| Johnson County Clin-Trials (JCCT) | Lenexa | Kansas | 66219 | — |
| Alliance for Multispecialty Research - Wichita East - Heartland Research Associates | Wichita | Kansas | 67207 | — |
| Alliance for Multispecialty Research - Lexington | Lexington | Kentucky | 40509 | — |
| DelRicht Research - New Orleans - Prytania Street | New Orleans | Louisiana | 70115 | — |
| DelRicht Research - Prairieville | Prairieville | Louisiana | 70769 | — |
| Rochester Clinical Research | New York | New York | 14609 | — |
| Accellacare - Cary | Cary | North Carolina | 27518 | — |
| Accellacare of Hickory | Hickory | North Carolina | 28601 | — |
| Accellacare - Piedmont Healthcare | Statesville | North Carolina | 28625 | — |
| Accellacare - Tradd Court | Wilmington | North Carolina | 28401 | — |
| CTI Clinical Research Center | Cincinnati | Ohio | 45212 | — |
| DelRicht Research - Tulsa | Tulsa | Oklahoma | 74133 | — |
| Tekton Research - Oklahoma - Primary Health Partners | Yukon | Oklahoma | 73099 | — |
| Tekton Research - Austin | Austin | Texas | 78745 | — |
| Javara Research - Privia Medical Group Gulf Coast | Conroe | Texas | 77384 | — |
| Tekton Research - San Antonio | San Antonio | Texas | 78229 | — |
| DelRicht Research - Virgina | Sterling | Virginia | 20166 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06560151, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 1, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06560151 live on ClinicalTrials.gov.