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trivalent vaccine candidate

Phase 1

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

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

trivalent vaccine candidate · 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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Frequently asked questions about trivalent vaccine candidate

What is the trivalent vaccine candidate used for?

The trivalent vaccine candidate is used for Lower Respiratory Tract Disease. It is being studied in older adults, specifically those aged 60 years and older, to evaluate its safety and immune response. The vaccine targets respiratory pathogens including RSV, hMPV, and PIV3.

What does the trivalent vaccine candidate target?

The trivalent vaccine candidate targets three respiratory viruses: respiratory syncytial virus (RSV), human metapneumovirus (hMPV), and parainfluenza virus type 3 (PIV3). It is designed to provide protection against lower respiratory tract disease caused by these pathogens in older adults.

Who makes the trivalent vaccine candidate?

Sanofi (ticker: SNY) is developing the trivalent vaccine candidate. The company is conducting a Phase 1 clinical trial to assess the vaccine's safety and immunogenicity in older adults.

What phase is the trivalent vaccine candidate in?

The trivalent vaccine candidate is in Phase 1 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. The ongoing trial is actively enrolling participants, though recruitment is not yet complete.

What clinical trials is the trivalent vaccine candidate in?

The trivalent vaccine candidate is being evaluated in a Phase 1 trial with NCT number NCT07295028. This randomized, double-blind, placebo-controlled study is enrolling 240 participants aged 60 years and older in Australia. The trial is active but not currently recruiting.

Is the trivalent vaccine candidate the same as VXB-251?

Yes, the trivalent vaccine candidate is also known as VXB-251. It is a vaccine candidate targeting RSV, hMPV, and PIV3, and is being studied in older adults for the prevention of lower respiratory tract disease.