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3.75 µg H5N8 antigen plus full dose AS03A

Phase 2

Influenza | Monoclonal antibody | Infectious Disease |Icon Plc|Last Updated: Jan 9, 2026

Success Probability

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment1,380

FDA Designations

No designations recorded

Clinical trial landscape

3.75 µg H5N8 antigen plus full dose AS03A · 1 trial · 1 indication

Phase 2 1
NCT06560151Assess Safety and Immunogenicity of A/H5 Inactivated Monovalent Influenza Vaccines at Different Antigen Dose Levels Adjuvanted With AS03 or MF59Influenza
COMPLETED1,380 Analytics
PHASE2COMPLETED
Assess Safety and Immunogenicity of A/H5 Inactivated Monovalent Influenza Vaccines at Different Antigen Dose Levels Adjuvanted With AS03 or MF59
Influenza
NCT065601511,380
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Study Endpoints

Primary Endpoints

The percentage of participants who experience any solicited local reactogenicity symptom occurring within 8 days of each vaccination, inclusive of the vaccination day.
Day 1 through Day 8 and Day 22 through Day 29
The percentage of participants who experience any solicited systemic reactogenicity symptom occurring within 8 days of each vaccination, inclusive of the vaccination day.
Day 1 through Day 8 and Day 22 through Day 29
The percentage of participants achieving seroprotection at Day 43 based on serum HAI antibody titers (≥1:40) to A/Astrakhan (H5N8).
Day 43

Secondary Endpoints

The percentage of participants who experience any unsolicited TEAE within 22 days of each vaccination, inclusive of the vaccination day.
Day 1 through Day 22 and Day 22 through Day 43
The percentage of participants who experience any treatment-emergent SAE.
Day 1 through Day 203
The percentage of participants who experience any treatment-emergent MAAE.
Day 1 through Day 203
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeOTHER

Treatment Arms

ArmTypeDescription
Treatment Group AEXPERIMENTALThis treatment group of 60 participants (ages 18-64) in Treatment Group A will receive 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose of AS03A.
Treatment Group BEXPERIMENTALThis treatment group of 120 participants (60 participants ages 18-64 and 60 participants ages ≥65) in Treatment Group B will receive 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) adjuvanted with a full dose of AS03A.
Treatment Group CEXPERIMENTALThis treatment group of 120 participants (60 participants ages 18-64 and 60 participants age ≥65) will receive 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) adjuvanted with a full dose of AS03A.
Treatment Group DEXPERIMENTALThis treatment group of 60 participants (ages 18-64) will receive 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) adjuvanted with a half dose of AS03A.
Treatment Group EEXPERIMENTALThis treatment group of 120 participants (60 participants ages 18-64 and 60 participants age ≥65) will receive 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) adjuvanted with a half dose of AS03A.
Treatment Group FEXPERIMENTALThis treatment group of 120 participants (60 participants ages 18-64 and 60 participants age ≥65 will receive 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) adjuvanted with a half dose of AS03A.
Treatment Group GEXPERIMENTALThis treatment group of 60 participants (ages 18-64) will receive 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) adjuvanted with MF59.
Treatment Group HEXPERIMENTALThis treatment group of 120 participants (60 participants ages 18-64 and 60 participants age ≥65) will receive 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) adjuvanted with MF59.
Treatment Group IEXPERIMENTALThis treatment group of 120 participants (60 participants ages 18-64 and 60 participants age ≥65) will receive 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) adjuvanted with MF59.
Treatment Group JEXPERIMENTALThis treatment group of 60 participants (ages 18-64) will receive 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) adjuvanted with a full dose of AS03A.
Treatment Group KEXPERIMENTALThis treatment group of 120 participants (60 participants ages 18-64 and 60 participants age ≥65) will receive 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) adjuvanted with a full dose of AS03A.
Treatment Group LEXPERIMENTALThis treatment group of 60 participants (ages ≥65) will receive 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) adjuvanted with a full dose of AS03A.
Treatment Group MEXPERIMENTALThis treatment group of 60 participants (ages 18-64) will receive 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) adjuvanted with MF59.
Treatment Group NEXPERIMENTALThis treatment group of 120 participants (60 participants ages 18-64 and 60 participants age ≥65) will receive 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) adjuvanted with MF59.
Treatment Group OEXPERIMENTALThis treatment group of 60 participants (age ≥65) will receive 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) adjuvanted with MF59.

Interventions

NameTypeDescription
3.75 µg H5N8 antigen plus full dose AS03ABIOLOGICALTwo intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine.
7.5 µg H5N8 antigen plus full dose AS03ABIOLOGICALTwo intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine.
15 µg H5N8 antigen plus full dose AS03ABIOLOGICALTwo intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine.
3.75 µg H5N8 antigen plus half dose AS03ABIOLOGICALTwo intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine.
7.5 µg H5N8 antigen plus half dose AS03ABIOLOGICALTwo intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine.
15 µg H5N8 antigen plus half dose AS03ABIOLOGICALTwo intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine.
3.75 µg H5N8 antigen plus MF59BIOLOGICALTwo intramuscular doses (21 days apart) of MF59 adjuvanted H5N8 vaccine.
7.5 µg H5N8 antigen plus MF59BIOLOGICALTwo intramuscular doses (21 days apart) of MF59 adjuvanted H5N8 vaccine.
15 µg H5N8 antigen plus MF59BIOLOGICALTwo intramuscular doses (21 days apart) of MF59 adjuvanted H5N8 vaccine.
3.75 µg H5N1 antigen plus full dose AS03ABIOLOGICALTwo intramuscular doses (21 days apart) of AS03A adjuvanted H5N1 vaccine.
7.5 µg H5N1 antigen plus full dose AS03ABIOLOGICALTwo intramuscular doses (21 days apart) of AS03A adjuvanted H5N1 vaccine.
15 µg H5N1 antigen plus full dose AS03ABIOLOGICALTwo intramuscular doses (21 days apart) of AS03A adjuvanted H5N1 vaccine.
3.75 µg H5N1 antigen plus MF59BIOLOGICALTwo intramuscular doses (21 days apart) of MF59 adjuvanted H5N1 vaccine.
7.5 µg H5N1 antigen plus MF59BIOLOGICALTwo intramuscular doses (21 days apart) of MF59 adjuvanted H5N1 vaccine.
15 µg H5N1 antigen plus MF59BIOLOGICALTwo intramuscular doses (21 days apart) of MF59 adjuvanted H5N1 vaccine.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites20

Inclusion Criteria: 1. Male or non-pregnant female, 18 years of age or older at the time of screening and informed consent. 2. Willing and able to provide written informed consent prior to initiation of study procedures. 3. Agrees to have specimens collected during this trial specifically for the p...

Countries:United States
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Competitive Landscape -Influenza 14 trials

CompanyTickerTrialsLead PhaseDrugs
Sinovac Biotech Ltd.SVA1PHASE3Participants will receive one dose of vaccine of Sinovac QIV, Vaxigrip QIV
GSK plc Sponsored ADRGSK2PHASE2Flu mRNA, Comparator 1, Comparator 2, Comparator 3
Moderna, Inc.MRNA1PHASE3mRNA-1018-H5
Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)CDTX1PHASE3CD388
Traws Pharma, Inc.TRAW2PHASE2TRX-100
AstraZeneca PLCAZN1PHASE1AZD4117, AZD5315
Sanofi SA Sponsored ADRSNY2 - Efluelda Tetra Pre-filled syringe
Pfizer Inc.PFE1 - COVID-19 Vaccine
Abbott LaboratoriesABT1N/AUndisclosed
Grace Therapeutics, Inc.GRCE1N/AUndisclosed
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Frequently asked questions about 3.75 µg H5N8 antigen plus full dose AS03A

What is 3.75 µg H5N8 antigen plus full dose AS03A used for?

3.75 µg H5N8 antigen plus full dose AS03A is an investigational vaccine being studied for the prevention of influenza. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities. The vaccine is designed to elicit an immune response against the H5N8 influenza strain.

Who makes 3.75 µg H5N8 antigen plus full dose AS03A?

3.75 µg H5N8 antigen plus full dose AS03A is being developed by Icon Plc, a company listed on the stock exchange under the ticker ICLR. The vaccine is currently in Phase 2 clinical trials for influenza.

What phase is 3.75 µg H5N8 antigen plus full dose AS03A in?

3.75 µg H5N8 antigen plus full dose AS03A is in Phase 2 clinical development. It is an investigational vaccine and has not yet been approved for use. The Phase 2 trial has been completed, with results not yet publicly reported.

What clinical trials is 3.75 µg H5N8 antigen plus full dose AS03A in?

3.75 µg H5N8 antigen plus full dose AS03A was studied in a completed Phase 2 trial registered as NCT06560151. The trial assessed the safety and immunogenicity of A/H5 inactivated monovalent influenza vaccines at different antigen dose levels adjuvanted with AS03 or MF59. The study enrolled 1380 participants in the United States.

Is 3.75 µg H5N8 antigen plus full dose AS03A the same as other H5N8 vaccines?

3.75 µg H5N8 antigen plus full dose AS03A is a specific formulation of an H5N8 influenza vaccine. It combines a low dose of H5N8 antigen with a full dose of the AS03A adjuvant. Other H5N8 vaccines may use different antigen doses or adjuvants, such as MF59.