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VXB-251

Phase 1

Lower Respiratory Tract Disease | Monoclonal antibody | Respiratory |Sanofi|Last Updated: May 20, 2026

Target and mechanism

ModalityMonoclonal antibody

Also known as trivalent vaccine candidate

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment240

FDA Designations

No designations recorded

Clinical trial landscape

VXB-251 · 1 trial · 2 indications

Phase 1 1
NCT07295028Study of an RSV-hMPV-PIV3 Trivalent Vaccine Candidate VXB-251 in Older AdultsLower Respiratory Tract Disease
ACTIVE NOT_RECRUITING240 Analytics
PHASE1ACTIVE NOT_RECRUITING
Study of an RSV-hMPV-PIV3 Trivalent Vaccine Candidate VXB-251 in Older Adults
Lower Respiratory Tract Disease
NCT07295028240
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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 to 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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