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Pandemic flu H5 mRNA vaccine

Phase 1

Influenza Immunization | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Apr 23, 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 Enrollment276
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06727058Study to Evaluate Safety and Immunogenicity of a Pandemic Flu H5 mRNA Vaccine in Healthy Adults Aged 18 Years and OlderPHASE1 COMPLETED 276 — — Dec 9, 2024Mar 24, 2026Apr 23, 202614 United States
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Study Endpoints
Primary Endpoints
Presence of immediate adverse events (AEs) within 30 minutes after each/any injection
Within 30 minutes of any/each injections

Number of participants experiencing immediate AEs

Presence of solicited injection site reactions through 7 days after each/any injection
Through 7 days after each/any injections

Number of participants experiencing solicited injection site reactions

Presence of solicited systemic site reactions through 7 days after each/any injection
Through 7 days after each/any injections

Number of participants experiencing solicited systemic site reactions

Presence of unsolicited AEs through 21 days after the first injection and through 28 days after the second injection
Through 21 days after the first injection and through 28 days after the second injection

Number of participants experiencing unsolicited AEs

Presence of medically attended adverse events (MAAEs) through 180 days after the last injection
Through 180 days after the last injection

Number of participants experiencing MAAEs

Presence of adverse events of special interest (AESIs) throughout the study
Throughout the study, approximately 13 months

Number of participants experiencing AESIs

Presence of serious adverse events (SAEs) throughout the study
Throughout the study, approximately 13 months

Number of participants experiencing SAEs

Presence of out-of-range biological test results (including shift from baseline values) through a maximum of 8 days after each injection
Through a maximum of 8 days after each injection

Number of participants with out-of-range biological test results

Secondary Endpoints
Antibody titers measured by Hemagglutination Inhibition (HAI) Assay
At Day 01, Day 22, Day 43, Day 112, and Day 202
Individual HAI titer ratio
At Day 22/Day 01, Day 43/Day 01, Day 112/Day 01, and Day 202/Day 01
≥ 4-fold increase in HAI titer [1/dilution])
At Day 22 or Day 43
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelSEQUENTIAL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Group 1: Low Dose Pandemic flu H5 mRNA vaccineEXPERIMENTALParticipants will receive 2 injections of pandemic flu H5 mRNA vaccine 21 days apart (at Day 01 and Day 22)
Group 2: Medium Dose Pandemic flu H5 mRNA vaccineEXPERIMENTALParticipants will receive 2 injections of pandemic flu H5 mRNA vaccine 21 days apart (at Day 01 and Day 22)
Group 3: High Dose Pandemic flu H5 mRNA vaccineEXPERIMENTALParticipants will receive 2 injections of pandemic flu H5 mRNA vaccine 21 days apart (at Day 01 and Day 22)
Group 4: PlaceboPLACEBO_COMPARATORParticipants will receive 2 injections of placebo 21 days apart (at Day 01 and Day 22)
Interventions
NameTypeDescription
Pandemic flu H5 mRNA vaccineBIOLOGICALPharmaceutical Form: Suspension for injection Route of Administration: Intramuscular (IM)
PlaceboOTHERPharmaceutical Form: Liquid solution for injection Route of Administration: Intramuscular (IM)
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites14

Inclusion Criteria: * Aged 18 years or older on the day of inclusion. * A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies: * Is of non-childbearing potential. To be considered of non-childbearing potential, a femal...

Countries:United States
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT06727058TRIAL_REMOVED: changed
LOWMay 24, 2026NCT06727058studyFirstPostDate: changed