Recent Updates
Recently added Catalysts

RSV vaccine candidate

Phase 2

Respiratory Syncytial Virus Infection | Monoclonal antibody | Respiratory |Sanofi|Last Updated: Mar 10, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment4,541
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06251024Study of a Respiratory Syncytial Virus Candidate Formulation in Adults Aged 60 Years and OlderPHASE2 COMPLETED 4,541Apr 2, 2024Mar 11, 2025Mar 10, 202625 Australia, Chile +4
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Presence of the first episode of RSV-LRTD (RSV A and/or RSV B) ≥ 14 days after vaccination
≥ 14 days after vaccination

Number of participants experiencing RSV-LRTD (RSV A and/or RSV B) ≥ 14 days after vaccination

Secondary Endpoints
Presence of the first episode of RSV-ARD (RSV A and/or RSV B) ≥ 14 days after vaccination
≥ 14 days after vaccination
Presence of the first episode of RSV MAARD (RSV A and/or RSV B) ≥ 14 days after vaccination
≥ 14 days after vaccination
Presence of the first episode of RSV LRTD (RSV A) occurring ≥ 14 days after vaccination)
≥ 14 days after vaccination
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Group 1: RSV vaccine candidateEXPERIMENTALParticipants will be enrolled in a 1:1 ratio to receive a single IM administration of the RSV vaccine candidate.
Group 2: placeboPLACEBO_COMPARATORParticipants will be enrolled in a 1:1 ratio to receive a single IM administration of the placebo.
Interventions
NameTypeDescription
RSV vaccine candidateBIOLOGICALPharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
PlaceboBIOLOGICALPharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
Unlock Study Design Details
Eligibility Criteria
Age Range60 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites25

Inclusion Criteria: * Aged 60 years or older on the day of inclusion * A female participant is eligible to participate if she is not pregnant or breastfeeding and: • Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 y...

Countries:AustraliaChileColombiaDominican RepublicHondurasMexico
Unlock Eligibility Criteria
Recent Changes (Last 90 Days)
MEDIUMMay 21, 2026NCT06251024TRIAL_REMOVED: changed
MEDIUMMay 21, 2026NCT06251024TRIAL_REMOVED: changed