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Bivalent RSV+HMPV protein vaccine

Phase 2

Respiratory Syncytial Virus | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Sep 9, 2026

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

Clinical trial landscape

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
NOT YET_RECRUITING8,000 Analytics
PHASE2NOT YET_RECRUITING
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

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...

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Recent Changes (Last 90 Days)

LOWSep 9, 2026NCT07810010NEW_TRIAL: changed
LOWSep 9, 2026NCT07810010NEW_TRIAL: changed