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Bivalent RSV+HMPV protein vaccine

Phase 2

Respiratory Syncytial Virus | Vaccine | Infectious Disease |Sanofi|Trials Updated: Oct 19, 2026

Bivalent RSV+HMPV protein vaccine development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Sep 2026

Bivalent RSV+HMPV protein vaccine target and mechanism

ModalityVaccine

Also known as RPF08203

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment8,000

FDA Designations

No designations recorded

Bivalent RSV+HMPV protein vaccine clinical trials

Bivalent RSV+HMPV protein vaccine · 1 trial · 3 indications

Phase 2 1
NCT07810010Phase 2b Study of a Respiratory Syncytial Virus and Human Metapneumovirus (RSV+HMPV) Protein Vaccine Candidate in Adults 60 Years of Age and OlderRespiratory Syncytial Virus
RECRUITING8,000 Analytics
PHASE2RECRUITING
Phase 2b Study of a Respiratory Syncytial Virus and Human Metapneumovirus (RSV+HMPV) Protein Vaccine Candidate in Adults 60 Years of Age and Older
Respiratory Syncytial VirusUnlock trial analytics

Study Endpoints

Primary Endpoints

Occurrence of the first episode of RSV-LRTD (Lower Respiratory Tract Disease)
From 14 days to 12 months after vaccination
Occurrence of the first episode of HMPV-LRTD
From 14 days to 12 months after vaccination

Secondary Endpoints

Occurrence of the first episode of RSV-LRTD and/or HMPV-LRTD
From 14 days to 12 months after vaccination
Occurrence of the first episode of RSV-ARD (Acute Respiratory Disease) and/or HMPV-ARD
From 14 days to 12 months after vaccination
Occurrence of the first episode of severe RSV-LRTD and/or severe HMPV-LRTD
From 14 days to 12 months after vaccination
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Safety Lead-in Cohort - ExperimentalEXPERIMENTALSingle administration of IM (intramuscular) injection of the bivalent RSV+HMPV protein vaccine candidate
Safety Lead-in Cohort - PlaceboPLACEBO_COMPARATORSingle administration of matching placebo
Main Cohort - ExperimentalEXPERIMENTALSingle administration of IM (intramuscular) injection of the bivalent RSV+HMPV protein vaccine candidate
Main Cohort - PlaceboPLACEBO_COMPARATORSingle administration of matching placebo

Interventions

NameTypeDescription
Bivalent RSV+HMPV protein vaccineBIOLOGICALIM injection
PlaceboBIOLOGICALIM injection
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Eligibility Criteria

Age Range60 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites21

Inclusion Criteria: * Aged 60 years or older on the day of inclusion * Participants who, as determined by medical evaluation including medical history, physical examination, and clinical judgment of the Investigator are eligible for inclusion Exclusion Criteria: * Known/suspected immunodeficiency...

Countries:AustraliaUnited Kingdom
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Recent Changes (Last 90 Days)

LOWOct 19, 2026NCT07810010lastUpdatePostDate: changed
LOWOct 19, 2026NCT07810010lastUpdatePostDate: changed
LOWOct 19, 2026NCT07810010lastUpdatePostDate: changed
LOWSep 16, 2026NCT07810010Status: NOT_YET_RECRUITING → RECRUITING
LOWSep 16, 2026NCT07810010Status: NOT_YET_RECRUITING → RECRUITING
LOWSep 9, 2026NCT07810010NEW_TRIAL: changed
LOWSep 9, 2026NCT07810010NEW_TRIAL: changed

Frequently asked questions about Bivalent RSV+HMPV protein vaccine

What is the bivalent RSV+HMPV protein vaccine?

The bivalent RSV+HMPV protein vaccine is an investigational vaccine developed by Sanofi that combines respiratory syncytial virus and human metapneumovirus antigens in a single product. It is designed to protect older adults against both viruses at once. It is currently in Phase 2 clinical development and has not been approved by any regulatory agency.

What is the bivalent RSV+HMPV protein vaccine used for?

It is being developed to prevent respiratory disease caused by respiratory syncytial virus and human metapneumovirus in adults 60 years of age and older. The Phase 2b trial enrolls healthy volunteers in this age group. Because the vaccine remains investigational, no approved indication has been granted.

Who is developing the bivalent RSV+HMPV protein vaccine?

Sanofi is developing the bivalent RSV+HMPV protein vaccine. Sanofi trades on the New York Stock Exchange under the ticker SNY. The company is running the candidate as a single combination vaccine covering two respiratory viruses rather than as separate products.

What phase is the bivalent RSV+HMPV protein vaccine in?

The bivalent RSV+HMPV protein vaccine is in Phase 2 development. One Phase 2b trial is currently recruiting, and no trials for this candidate have been completed. It is an investigational vaccine and is not FDA approved.

What clinical trial is the bivalent RSV+HMPV protein vaccine in?

The bivalent RSV+HMPV protein vaccine is being studied in NCT07810010, a Phase 2b trial titled a study of a respiratory syncytial virus and human metapneumovirus protein vaccine candidate in adults 60 years of age and older. The trial is recruiting, plans to enroll 8,000 participants, and runs in Australia and the United Kingdom.

How is the Phase 2b trial of the bivalent RSV+HMPV protein vaccine designed?

NCT07810010 is a randomized, double-blind, placebo-controlled Phase 2b trial of the bivalent RSV+HMPV protein vaccine. It targets 8,000 participants aged 60 years and older, includes both sexes, and enrolls healthy volunteers. The study is recruiting in Australia and the United Kingdom.