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parainfluenza virus type 3 vaccine

Phase 1

Respiratory Syncytial Virus Infection | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Apr 23, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment390
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06604767Study of a Respiratory Syncytial Virus/Human Metapneumovirus/Parainfluenza Virus Type 3 Vaccine Candidate in Adults Aged 60 Years and OlderPHASE1 COMPLETED 390 — — Sep 17, 2024Mar 24, 2026Apr 23, 20268 Australia
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Study Endpoints
Primary Endpoints
Presence of unsolicited systemic adverse events (AEs) reported in the 30 minutes after each vaccination
Within 30 minutes after each vaccination

Number of participants experiencing immediate unsolicited systemic AEs

Presence of solicited administration site reactions within 7 days after vaccination
Within 7 days after vaccination

Number of participants reporting: \- injection site reactions: pain, erythema and swelling

Presence of solicited systemic reactions within 7 days after vaccination
Within 7 days after vaccination

Number of participants reporting: * systemic reactions: fever, headache, fatigue, myalgia, arthralgia and chills

Presence of unsolicited AEs within 28 days after vaccination
Within 28 days after vaccination

Number of participants experiencing unsolicited AEs

Presence of serious adverse events (SAEs)
Within 6 months after vaccination

Number of participants experiencing SAEs regardless of causality

Presence of adverse events of special interest (AESIs)
Within 6 months after vaccination

Number of participants experiencing AESIs regardless of causality

Presence of related SAEs throughout the study
Throughout the study, approximately 12 months

Number of participants experiencing related SAEs regardless of causality

Presence of related AESIs throughout the study
Throughout the study, approximately 12 months

Number of participants experiencing related AESIs regardless of causality

Presence of related fatal SAEs throughout the study
Throughout the study, approximately 12 months

Number of participants experiencing related fatal SAEs regardless of causality

Presence of out-of-range biological test results (including shift from baseline values)
Within 7 days after vaccination

Number of participants with biological safety assessment values out of normal range (as per the laboratory performing the test, including shift from baseline values)

Secondary Endpoints
RSV A serum neutralizing antibody (nAb) titers at pre-vaccination (Day 01) and post-vaccination (Day 29) in the RSV/hMPV +/- PIV3 and RSV vaccines
At Day 01 and Day 29
RSV B serum nAb titers at pre-vaccination (Day 01) and post-vaccination (Day 29) in the RSV/hMPV +/- PIV3 and RSV vaccines
At Day 01 and Day 29
hMPV A serum nAb titers at pre-vaccination (Day 01) and post-vaccination (Day 29) in the RSV/hMPV +/- PIV3 vaccines
At Day 01 and Day 29
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
PIV3 Dose 1EXPERIMENTALParticipants will receive a single intramuscular (IM) injection at Day 1
PIV3 Dose 2EXPERIMENTALParticipants will receive a single intramuscular (IM) injection at Day 1
PIV3 Dose 3EXPERIMENTALParticipants will receive a single intramuscular (IM) injection at Day 1
PIV3 Dose 4EXPERIMENTALParticipants will receive a single intramuscular (IM) injection at Day 1
RSV/hMPV /PIV3 Formulation 1EXPERIMENTALParticipants will receive a single intramuscular (IM) injection at Day 1
RSV/hMPV Formulation 1EXPERIMENTALParticipants will receive a single intramuscular (IM) injection at Day 1
RSV/hMPV Formulation 2EXPERIMENTALParticipants will receive a single intramuscular (IM) injection at Day 1
RSV vaccine 1EXPERIMENTALParticipants will receive a single intramuscular (IM) injection at Day 1
RSV vaccine 2EXPERIMENTALParticipants will receive a single intramuscular (IM) injection at Day 1
Interventions
NameTypeDescription
parainfluenza virus type 3 vaccine (PIV3)BIOLOGICALPharmaceutical form:Frozen liquid solution -Route of administration:Intramuscular
RSV/hMPV/PIV3 vaccineBIOLOGICALPharmaceutical form:Frozen liquid solution-Route of administration:Intramuscular
RSV/hMPV vaccineBIOLOGICALPharmaceutical form:Frozen liquid solution-Route of administration:Intramuscular
RSV vaccine 1BIOLOGICALPharmaceutical form:Suspension for injection-Route of administration:Intramuscular
RSV vaccine 2BIOLOGICALPharmaceutical form:Frozen liquid solution-Route of administration:Intramuscular
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Eligibility Criteria
Age Range60 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites8

Inclusion Criteria: * Aged 60 years or older on the day of inclusion (means from the means from the day of the 60th birthday). * Informed consent form (ICF) has been signed and dated * A female participant is eligible to participate if she is of non-childbearing potential. To be considered of non-c...

Countries:Australia
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT06604767TRIAL_REMOVED: changed
LOWMay 24, 2026NCT06604767studyFirstPostDate: changed