Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 2 study, sponsored by Biomedical Advanced Research and Development Authority.
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, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (938% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The percentage of participants who experienced at least one solicited local reactogenicity adverse event at the injection site during at least one of the time frames specified. Possible reactions included erythema/redness, induration (underlying hardening of tissue associated with inflammation)/swelling (localized tissue distention), and pain.
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 |
What the finished NCT06560151 record still lists
NCT06560151 is an interventional study that assigns participants to a tested intervention. Its 1,380 participants enrollment target places it among the larger protocols in the corpus, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (938% higher).
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06560151's enrollment target sits among peer trials
1,380 13th of 2000 higher than 1,988 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06651281 · 1,380 participants · Phase 3
Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)
- NCT07256392 · 1,370 participants · Phase 3
Long-term Efficacy and Safety Extension (LTE) Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria
- NCT04489238 · 1,366 participants
Collection of Information to Better Understand Young Onset Colorectal Cancer
- NCT05006131 · 1,395 participants
Pancreatic Cancer Screening for At-risk Individuals
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI