Assess Safety and Immunogenicity of A/H5 Inactivated Monovalent Influenza Vaccines at Different Antigen Dose Levels Adjuvanted With AS03 or MF59
NCT06560151 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1380
Last updated 2026-01-09
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.
Conditions
Interventions
- BIOLOGICAL
-
7.5 µg H5N8 antigen plus full dose AS03A
Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine.
- BIOLOGICAL
-
15 µg H5N8 antigen plus full dose AS03A
Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine.
- BIOLOGICAL
-
3.75 µg H5N8 antigen plus half dose AS03A
Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine.
- BIOLOGICAL
-
7.5 µg H5N8 antigen plus half dose AS03A
Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine.
- BIOLOGICAL
-
15 µg H5N8 antigen plus half dose AS03A
Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine.
- BIOLOGICAL
-
3.75 µg H5N8 antigen plus MF59
Two intramuscular doses (21 days apart) of MF59 adjuvanted H5N8 vaccine.
- BIOLOGICAL
-
7.5 µg H5N8 antigen plus MF59
Two intramuscular doses (21 days apart) of MF59 adjuvanted H5N8 vaccine.
- BIOLOGICAL
-
15 µg H5N8 antigen plus MF59
Two intramuscular doses (21 days apart) of MF59 adjuvanted H5N8 vaccine.
- BIOLOGICAL
-
3.75 µg H5N1 antigen plus full dose AS03A
Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N1 vaccine.
- BIOLOGICAL
-
7.5 µg H5N1 antigen plus full dose AS03A
Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N1 vaccine.
- BIOLOGICAL
-
15 µg H5N1 antigen plus full dose AS03A
Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N1 vaccine.
- BIOLOGICAL
-
3.75 µg H5N1 antigen plus MF59
Two intramuscular doses (21 days apart) of MF59 adjuvanted H5N1 vaccine.
- BIOLOGICAL
-
7.5 µg H5N1 antigen plus MF59
Two intramuscular doses (21 days apart) of MF59 adjuvanted H5N1 vaccine.
- BIOLOGICAL
-
15 µg H5N1 antigen plus MF59
Two intramuscular doses (21 days apart) of MF59 adjuvanted H5N1 vaccine.
- BIOLOGICAL
-
3.75 µg H5N8 antigen plus full dose AS03A
Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine.
Sponsors & Collaborators
-
Rho Federal Systems Division, Inc.
collaborator INDUSTRY - collaborator INDUSTRY
-
Biomedical Advanced Research and Development Authority
lead FED
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-08-21
- Primary Completion
- 2025-01-02
- Completion
- 2025-06-11
- FDA Drug
- Yes
Countries
- United States
Study Locations
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