# Assess Safety and Immunogenicity of A/H5 Inactivated Monovalent Influenza Vaccines at Different Antigen Dose Levels Adjuvanted With AS03 or MF59

> **NCT06560151** · PHASE2 · COMPLETED · sponsor: **Biomedical Advanced Research and Development Authority** · enrollment: 1380 (actual)

## Conditions studied

- Influenza

## 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
- **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

## Key facts

- **NCT ID:** NCT06560151
- **Lead sponsor:** Biomedical Advanced Research and Development Authority
- **Sponsor class:** FED
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2024-08-21
- **Primary completion:** 2025-01-02
- **Final completion:** 2025-06-11
- **Target enrollment:** 1380 (ACTUAL)
- **Last updated:** 2026-01-09

## Collaborators

- [object Object]
- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT06560151

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT06560151, "Assess Safety and Immunogenicity of A/H5 Inactivated Monovalent Influenza Vaccines at Different Antigen Dose Levels Adjuvanted With AS03 or MF59". Retrieved via AI Analytics 2026-06-03 from https://api.ai-analytics.org/clinical/NCT06560151. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*
