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mRNA-1018-H5

Phase 3

Influenza | Monoclonal antibody | Infectious Disease |Moderna, Inc.|Last Updated: Apr 3, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment4,000
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07496450A Study of mRNA-1018-H5 Pandemic Influenza Vaccine in Healthy AdultsPHASE3 RECRUITING 4,000 — — Mar 23, 2026Jan 28, 2027Apr 3, 202636 United States, United Kingdom
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Study Endpoints
Primary Endpoints
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer ≥ 1:40 at Day 43
Day 43

HAI Titer \>=1:40.

Percentage of Participants With Seroconversion at Day 43, as Measured by HAI Assay
Day 43

Seroconversion is defined as a Day 43 titer ≥1:40 if baseline is \<1:10 or a 4-fold or greater rise if baseline is ≥1:10 in HAI titer measured by HAI assay.

Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Up to Day 29 (7 days after each injection)
Number of Participants with Unsolicited Adverse Events (AEs)
Up to Day 50 (28 days after each injection)
Number of Participants with AEs Leading to Discontinuation, Medically-attended AEs (MAAEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs)
Day 1 to Day 205
Secondary Endpoints
Geometric Mean Titer (GMT) of Anti-H5N1 Antibodies at Day 43, as Measured by Microneutralization (MN) Assay
Day 43
GMT of HAI Antibodies at Days 22 and 205, as Measured by HAI Assay
Days 22 and 205
GMT of HAI Antibodies at Days 22 and 205, as Measured by MN Assay
Days 22 and 205
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
mRNA-1018-H5 VaccineEXPERIMENTALParticipants will receive mRNA-1018-H5 vaccine by intramuscular (IM) injection on Day 1 and Day 22.
PlaceboPLACEBO_COMPARATORParticipants will receive placebo matched to mRNA-1018-H5 vaccine by IM injection on Day 1 and Day 22.
Interventions
NameTypeDescription
mRNA-1018-H5BIOLOGICALSterile liquid for injection.
PlaceboBIOLOGICALSterile liquid for injection.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites36

Key Inclusion Criteria: * Healthy as determined by medical evaluation including medical history; and physical examination. Participants with clinically stable chronic medical conditions are permitted. * Participants who are assigned female at birth or could become pregnant are eligible to participa...

Countries:United StatesUnited Kingdom
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Competitive Landscape -Influenza 16 trials
CompanyTickerTrialsLead PhaseDrugs
Sinovac Biotech Ltd.SVA1PHASE3Participants will receive one dose of vaccine of Sinovac QIV, Vaxigrip QIV
GSK plc Sponsored ADRGSK3PHASE2Flu mRNA, Comparator 1, Comparator 2, Comparator 3, Zanamivir
Moderna, Inc.MRNA1PHASE3mRNA-1018-H5
Traws Pharma, Inc.TRAW2PHASE2TRX-100, Influenza A/France/759/2021 virus
Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)CDTX1PHASE3CD388
Sanofi SA Sponsored ADRSNY3PHASE1Trivalent messenger ribonucleic acid hemagglutinin Vaccine 1, TIV mRNA-neuraminidase, TIV mRNA-HA Vaccine 2, Quadrivalent Influenza Standard Dose Vaccine, Efluelda Tetra Pre-filled syringe
AstraZeneca PLCAZN1PHASE1AZD4117, AZD5315
Unity Health TorontoUBX1PHASE3Baloxavir
Pfizer Inc.PFE1 — COVID-19 Vaccine
Abbott LaboratoriesABT1NAUndisclosed
Grace Therapeutics, Inc.GRCE1NAUndisclosed
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07496450primaryCompletionDate: changed
LOWMay 24, 2026NCT07496450studyFirstPostDate: changed