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Monovalent RSV Vaccine

Phase 1

RSV Infection | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Nov 20, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment385

FDA Designations

No designations recorded

Clinical trial landscape

Monovalent RSV Vaccine · 1 trial · 2 indications

Phase 1 1
NCT06583031Study to Evaluate the Safety and Immune Response of an Investigational Vaccine for the Prevention of RSV (Respiratory Syncytial Virus) and (hMPV) Human Metapneumovirus Infection in Participants Aged 60 to 75 YearsRSV Infection
COMPLETED385 Analytics
PHASE1COMPLETED
Study to Evaluate the Safety and Immune Response of an Investigational Vaccine for the Prevention of RSV (Respiratory Syncytial Virus) and (hMPV) Human Metapneumovirus Infection in Participants Aged 60 to 75 Years
RSV Infection
NCT06583031385
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Study Endpoints

Primary Endpoints

Presence of any unsolicited systemic Adverse Events (AEs) reported within 30 minutes after vaccination
On Day 1
Presence of solicited injection site and systemic reactions (ie, pre-listed in the participant's diary and in the eCRF (electronic case report form) occurring through 7 days after vaccination
Day 1 through day 8
Presence of unsolicited AEs reported through 28 days after vaccination
Day 1 through day 29
Presence of SAEs (Serious Adverse Events) and AESIs (Adverse Events of Special Interest) throughout the study (ie, through 6 months after vaccination
SAE: Screening through day 181; AESI: Day 1 through day 181
Presence of out-of-range biological test results (including shift from baseline values) through 7 days after vaccination
Screening through day 8

Secondary Endpoints

RSV A and RSV B serum nAb (neutralizing antibodies) titers at pre-vaccination and 28 days post-vaccination in all participants
At day 1 and day 29
hMPV A serum nAb titers at pre-vaccination and 28 days post-vaccination in all participants, except in those receiving the MV RSV vaccine
At day 1 and day 28
RSV A and RSV B nAb titers at pre-vaccination, 28 days, 3 months, and 6 months post-vaccination in all participants
At day 1, day 29, day 91, and day 181
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group 1 RSV/hMPV dose A1EXPERIMENTALParticipants will receive a single IM (Intramuscular) injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
Group 2 RSV/hMPV dose A2EXPERIMENTALParticipants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
Group 3 RSV/hMPV dose A3EXPERIMENTALParticipants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
Group 4 RSV/hMPV dose B1EXPERIMENTALParticipants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
Group 5 RSV/hMPV dose B2EXPERIMENTALParticipants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
Group 6 RSV/hMPV dose B3EXPERIMENTALParticipants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
Group 7 RSV/hMPV dose C1EXPERIMENTALParticipants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
Group 8 RSV/hMPV dose C2EXPERIMENTALParticipants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
Group 9 RSV/hMPV dose C3EXPERIMENTALParticipants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
Group 10 RSV/hMPV dose 1EXPERIMENTALParticipants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
Group 11 RSV/hMPV dose 2EXPERIMENTALParticipants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
Group 12 RSV/hMPV dose 3EXPERIMENTALParticipants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
Group 13 Monovalent RSV VaccineEXPERIMENTALParticipants will receive a single IM injection on day 1 of a Monovalent (MV) RSV vaccine according to their randomization schedule.

Interventions

NameTypeDescription
RSV/hMPV vaccine dose A1BIOLOGICALSuspension for injection. Route of administration: IM injection
RSV/hMPV vaccine dose A2BIOLOGICALSuspension for injection. Route of administration: IM injection
RSV/hMPV vaccine dose A3BIOLOGICALSuspension for injection. Route of administration: IM injection
RSV/hMPV vaccine dose B1BIOLOGICALSuspension for injection. Route of administration: IM injection
RSV/hMPV vaccine dose B2BIOLOGICALSuspension for injection. Route of administration: IM injection
RSV/hMPV vaccine dose B3BIOLOGICALSuspension for injection. Route of administration: IM injection
RSV/hMPV vaccine dose C1BIOLOGICALSuspension for injection. Route of administration: IM injection
RSV/hMPV vaccine dose C2BIOLOGICALSuspension for injection. Route of administration: IM injection
RSV/hMPV vaccine dose C3BIOLOGICALSuspension for injection. Route of administration: IM injection
RSV/hMPV vaccine dose 1BIOLOGICALSuspension for injection. Route of administration: IM injection
RSV/hMPV vaccine dose 2BIOLOGICALSuspension for injection. Route of administration: IM injection
RSV/hMPV vaccine dose 3BIOLOGICALSuspension for injection. Route of administration: IM injection
Monovalent RSV VaccineBIOLOGICALSuspension for injection. Route of administration: IM injection
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Eligibility Criteria

Age Range60 Years to 75 Years
SexALL
Healthy VolunteersYes
Study Sites6

Inclusion Criteria: * Aged 60 to 75 years on the day of inclusion * A female participant is eligible to participate if she is post-menopausal for at least 1 year, or surgically sterile Exclusion Criteria: * Any condition which, in the opinion of the Investigator, might interfere with the evaluati...

Countries:Australia
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Competitive Landscape -Bacterial Infections 60 trials (matched to "RSV Infection")

Top 20 of 28 competitors

CompanyTickerTrialsLead PhaseDrugs
Pfizer Inc.PFE5PHASE3VLA15
Sanofi SA Sponsored ADRSNY2PHASE3PCV21, 20vPCV
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
CorMedix Inc.CRMD2PHASE3catheter lock, Heparin
GSK plc Sponsored ADRGSK3PHASE2MenABCWY vaccine
Sinovac Biotech Ltd.SVA4PHASE3Sinovac PCV13, Prevnar
Novartis AG Sponsored ADRNVS1PHASE2Cryptosporidium parvum oocysts, EDI048
Innoviva, Inc.INVA3PHASE2Eravacycline/kg
BiomX Inc.PHGE1PHASE2BX004
Merck & Co., Inc.MRK2PHASE1V118C, PCV20
ICON PlcICLR1PHASE2AV7909 Full Dose, AV7909 Half Dose
AstraZeneca PLCAZN1PHASE1AZD7760
BioNTech SE Sponsored ADRBNTX1PHASE1BNT163
60 Degrees Pharmaceuticals, Inc.SXTP1PHASE2Tafenoquine
Tarsus Pharmaceuticals, Inc.TARS1PHASE2TP-05 Low Dose
Moderna, Inc.MRNA1PHASE2mRNA-1982
AN2 Therapeutics, Inc.ANTX1PHASE2Epetraborole
Emergent BioSolutions Inc.EBS4 - AIGIV
Abbott LaboratoriesABT1N/AUndisclosed
CareDx, Inc.CDNA1 - Undisclosed
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