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mRNA-1018-H5

Phase 3

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

Success Probability
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment4,000
FDA Designations
No designations recorded
Clinical trial landscape

mRNA-1018-H5 · 1 trial · 1 indication

Phase 3 1
NCT07496450A Study of mRNA-1018-H5 Pandemic Influenza Vaccine in Healthy AdultsInfluenza
RECRUITING4,000 Analytics
PHASE3RECRUITING
A Study of mRNA-1018-H5 Pandemic Influenza Vaccine in Healthy Adults
Influenza
NCT074964504,000
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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 to 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 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
Unity Health TorontoUBX1PHASE3Baloxavir
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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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07496450primaryCompletionDate: changed
LOWMay 24, 2026NCT07496450studyFirstPostDate: changed