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RSV mRNA LNP 1

Phase 1

Respiratory Syncytial Virus Infection | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Sep 11, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment558

FDA Designations

No designations recorded

Clinical trial landscape

RSV mRNA LNP 1 · 1 trial · 3 indications

Phase 1 1
NCT06237296Study of the Safety and Immune Response of an Investigational mRNA Vaccine for the Prevention of Respiratory Syncytial Virus and/or Human Metapneumovirus in Participants Aged 18 to 49 Years and 60 Years and OlderRespiratory Syncytial Virus Infection
COMPLETED558 Analytics
PHASE1COMPLETED
Study of the Safety and Immune Response of an Investigational mRNA Vaccine for the Prevention of Respiratory Syncytial Virus and/or Human Metapneumovirus in Participants Aged 18 to 49 Years and 60 Years and Older
Respiratory Syncytial Virus Infection
NCT06237296558
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Study Endpoints

Primary Endpoints

Presence of unsolicited systemic immediate adverse events (AEs)
Within 30 minutes after vaccination

Number of participants experiencing immediate an immediate unsolicited systemic adverse event

Presence of solicited injection site or systemic reactions
Within 7 days after vaccination

Number of participants reporting: * injection site reactions: pain, erythema and swelling * systemic reactions: fever, headache, fatigue, myalgia, arthralgia and chills

Presence of unsolicited AEs
Within 28 days after vaccination

Number of participants experiencing unsolicited AEs

Presence of medically attended adverse events (MAAEs)
Throughout study (up to approximately 6 months)

Number of participants experiencing MAAEs

Presence of serious adverse events (SAEs)
Throughout study (up to approximately 6 months)

Throughout study (up to approximately 6 months)

Presence of adverse events of special interest (AESIs)
Throughout study (up to approximately 6 months)

Number of participants experiencing AESIs

Presence of out-of-range biological test results
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)

RSV-A serum neutralizing antibody (nAb) titers at pre-vaccination (D01) and 28 days post- vaccination (D29) in the RSV/hMPV and monovalent RSV formulations
Day 1 and Day 29

RSV-A serum nAb titers at pre-vaccination (D01), 28 days (D29) post-vaccination

RSV-B serum neutralizing antibody (nAb) titers at pre-vaccination (D01) and 28 days post- vaccination (D29) in the RSV/hMPV and monovalent RSV formulations
Day 1 and Day 29

RSV-B serum nAb titers at pre-vaccination (D01), 28 days (D29) post-vaccination

hMPV- A serum neutralizing antibody (nAb) titers at pre-vaccination (D01) and 28 days post- vaccination (D29) in the RSV/hMPV and monovalent hMPV formulations
Day 1 and Day 29

hMPV-A serum nAb titers at pre-vaccination (D01), 28 days (D29) post-vaccination

Secondary Endpoints

RSV A serum nAb titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination in the monovalent RSV formulation
Day 1, Day 29, Day 91 and Day 181
RSV B serum nAb titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination in the monovalent RSV formulation
Day 1, Day 29, Day 91 and Day 181
RSV A serum anti-F immunoglobulin G (IgG) antibody (Ab) titers at pre-vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination in the monovalent RSV formulation
Day 1, Day 29, Day 91 and Day 181
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
RSV/hMPV mRNA / LNP 1 Group 1EXPERIMENTALParticipants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 1.
RSV/hMPV mRNA / LNP 1 Group 2EXPERIMENTALParticipants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 2.
RSV/hMPV mRNA / LNP 1 Group 3EXPERIMENTALParticipants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 3.
RSV/hMPV mRNA / LNP 2 Group 4EXPERIMENTALParticipants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 2 dose 1.
RSV mRNA / LNP 1 Group 5EXPERIMENTALParticipants will be randomized to receive a single IM injection of RSV mRNA / LNP vaccine 1 dose 1.
hMPV mRNA / LNP 1 Group 6EXPERIMENTALParticipants will be randomized to receive a single IM injection of hMPV mRNA / LNP vaccine 1 dose 1.
RSV/hMPV mRNA / LNP 1 Group 7EXPERIMENTALParticipants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 4.

Interventions

NameTypeDescription
RSV/hMPV mRNA LNP 1BIOLOGICALPharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
RSV/hMPV mRNA LNP 2BIOLOGICALPharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
RSV mRNA LNP 1BIOLOGICALPharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
hMPV mRNA LNP 1BIOLOGICALPharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites17

Inclusion Criteria: -Informed consent form (ICF) has been signed and dated Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: -Any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives. ...

Countries:United StatesAustralia
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