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mRNA NA vaccine

Phase 1

Influenza Immunization | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Sep 15, 2025

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-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment233
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05426174Study to Assess the Safety and Immunogenicity of Monovalent mRNA NA Vaccine in Adult Participants 18 Years of Age and OlderPHASE1 COMPLETED 233 — — Jun 9, 2022Jan 3, 2024Sep 15, 20256 United States
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Study Endpoints
Primary Endpoints
Number of participants with immediate adverse events
Within 30 minutes after vaccination

Immediate adverse events are unsolicited systemic adverse events reported in the 30 minutes after vaccination

Number of participants with solicited injection site or systemic reaction
From Day 1 to Day 8
Number of participants with unsolicited adverse events
From Day 1 to Day 29

Unsolicited (spontaneously reported) adverse events not fulfilling criteria for solicited reactions

Number of participants with serious adverse events
From Day 1 to Day 366

Serious adverse events are collected throughout the study

Number of participants with adverse events of special interest
From Day 1 to Day 366

Adverse events of special interest are collected throughout the study

Number of patients with clinically significant changes in clinical laboratory tests
From Day 1 to Day 8

Laboratory tests include hematology: complete blood count (CBC) with differential, platelet count, coagulation panel (prothrombin time and PTT) and serum chemistry: alanine aminotransferase (ALT), aspartate aminotransferase (AST), total and fractionated bilirubin, C-reactive protein, serum creatinine, and blood urea nitrogen

Secondary Endpoints
Neuraminidase inhibition (NAI) Antibodies at Day 1 and 29
Day 1 and 29
Individual Neuraminidase inhibition (NAI) titer
Day 1 and Day 29
2-fold and 4-fold rise in NAI antibody titers
From Day 1 to Day 29
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Group 1 mRNA NA: Low dose LevelEXPERIMENTALParticipants will receive a low dose of mRNA vaccine
Group 2 mRNA NA: Medium dose levelEXPERIMENTALParticipants will receive a medium dose of mRNA vaccine
Group 3 mRNA NA: High dose levelEXPERIMENTALParticipants will receive a high dose of mRNA vaccine
Group 4: QIV-HDACTIVE_COMPARATORParticipants will receive QIV-HD (high dose quadrivalent influenza) vaccine
Interventions
NameTypeDescription
mRNA NA vaccineBIOLOGICALPharmaceutical form: Suspension for injection Route of administration: Intramuscular
High Dose Quadrivalent Influenza VaccineBIOLOGICALPharmaceutical form: Suspension for injection Route of administration: Intramuscular
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites6

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: 1. Is of non-childbearing potential. To be considered of non-childbearing potential, a fema...

Countries:United States
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