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trivalent vaccine candidate

Phase 1

Lower Respiratory Tract Disease | Monoclonal antibody | Other |Sanofi|Last Updated: May 20, 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 Enrollment240
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07295028Study of an RSV-hMPV-PIV3 Trivalent Vaccine Candidate VXB-251 in Older AdultsPHASE1 ACTIVE NOT_RECRUITING 240 — — Nov 17, 2025Apr 24, 2027May 20, 20266 Australia
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Study Endpoints
Primary Endpoints
Proportion of Participants With 1 or More Unsolicited Adverse Events (AEs)
1 month after IMP injection
Proportion of Participants With 1 or More Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), and Premature Discontinuation Associated AEs (PDAEs)
1 month after IMP injection
Proportion of Participants With 1 or More Solicited AEs
7 days after IMP injection
Secondary Endpoints
Proportion of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), and Premature Discontinuation Associated AEs (PDAEs)
6 and 12 months after IMP injection
Proportion of Participants With 1 or More Severe Solicited AEs
7 days after IMP injection
Geometric Mean Fold Increase (GMFI) of RSV-A, RSV-B, hMPV-A, hMPV-B, and PIV3 Serum Neutralizing Antibody Titers
Pre-injection baseline to 1 month, 6 months, and 12 months, after IMP injection
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
VXB-251, low doseEXPERIMENTAL -
VXB-251, medium doseEXPERIMENTAL -
VXB-251, high doseEXPERIMENTAL -
VXB-241EXPERIMENTAL -
VXB-213EXPERIMENTAL -
VXB-221EXPERIMENTAL -
VXB-232EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
trivalent (RSV/hMPV/PIV3) vaccine candidateBIOLOGICALVXB-251 low dose, single, IM injection.
bivalent (RSV/hMPV) unlicensed comparatorBIOLOGICALVXB-241 medium dose, single, IM injection.
monovalent (RSV) unlicensed comparatorBIOLOGICALVXB-213 medium dose, single, IM injection.
Biological/Vaccine: monovalent (hMPV) unlicensed comparatorBIOLOGICALVXB-221 medium dose, single, IM injection.
monovalent (PIV3) unlicensed comparatorBIOLOGICALVXB-232 medium dose, single, IM injection.
PlaceboOTHERdiluent, single, IM injection.
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Eligibility Criteria
Age Range60 Years — 83 Years
SexALL
Healthy VolunteersYes
Study Sites6

Inclusion Criteria: 1. Males and females aged 60 to 83 years of age at inclusion. 2. Evidence of signed and dated participant informed consent form (PICF) prior to any study procedure, indicating that the subject has been informed of all pertinent aspects of the study. 3. Willingness and ability to...

Countries:Australia
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT07295028studyFirstPostDate: changed