Recruiting

Phase 1

Phase 2

RSV+HMPV VaccinePhase 1/2 Study of Respiratory Syncytial Virus and Human Metapneumovirus (RSV+HMPV) Vaccine Candidate in Adults 60 Years of Age and Older

Sponsor:

Sanofi

Code:

NCT07734649

Conditions

Respiratory Syncytial Virus Immunization

Human Metapneumovirus Immunization

Healthy Volunteers

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Accepted

Interventions

RSV+HMPV vaccine

Control Vaccine 3

Control Vaccine 4

Control Vaccine 2

Placebo

Study Details

Brief summary:

This study is a Phase 1/2, randomized, observer-blind, active and placebo-controlled, multi-center study to be conducted in approximately 2400 adults 60 years of age and older. The aim of the study is to evaluate the immunogenicity and safety of an RSV+HMPV vaccine candidate for the prevention of RSV and HMPV disease among adults 60 years of age and older. While there are 3 FDA approved/licensed RSV vaccines currently available to the public, no vaccine is available for the prevention of HMPV in older adults. This study is intended to provide data in support of further clinical development of the RSV+HMPV vaccine candidate.

The study will consist of 4 cohorts and 11 vaccine groups (RSV+HMPV \[6 dose levels\], placebo and 4 control groups).

The duration of the study will be approximately 12 months for each participant.

Conditions

Respiratory Syncytial Virus Immunization

Human Metapneumovirus Immunization

Healthy Volunteers

Study ID

NCT07734649

Start date

Jul 22, 2026

Status verified date

Jul, 2026

Completion date

May 3, 2028

Anticipated

Primary completion date

May 3, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Accepted

Inclusion Criteria:

Aged 60 years or older on the day of inclusion
Non-childbearing potential (ie, post-menopausal for at least 1 year or surgically sterile)

Exclusion Criteria:

History of laboratory-confirmed RSV and/or laboratory-confirmed HMPV infection affecting the participant and/or the participant's household in the previous 12 months
Previous history of myocarditis, pericarditis, and/or myopericarditis
Screening electrocardiogram (ECG) that is consistent with possible myocarditis, pericarditis, and/or myopericarditis or, in the opinion of the investigator, demonstrates clinically relevant abnormalities that may affect participant safety or study results
Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
Previous history of Guillain-Barré Syndrome
Any vaccine given 4 weeks before or 4 weeks after study intervention
Previous vaccination against RSV and/or HMPV with an investigational or marketed vaccine
Receipt of any mRNA vaccine/product in the 2 months preceding study intervention administration
Has received a blood transfusion or blood-derived products, including immunoglobulins, in the past 3 months
Any screening laboratory parameter with laboratory abnormality > Grade 1 or deemed clinically significant by the investigator; if deemed appropriate, investigator may repeat these assessments

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design

Enrollment

2400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Group 1: RSV + HMPV Vaccine-Dose 1

Participants will receive RSV + HMPV vaccine corresponding to Dose 1 with a predefined antigen ratio

experimental: Group 2: RSV + HMPV Vaccine-Dose 2

Participants will receive RSV + HMPV vaccine corresponding to Dose 2 with a predefined antigen ratio

experimental: Group 3: RSV + HMPV Vaccine-Dose 3

Participants will receive RSV + HMPV vaccine corresponding to Dose 3 with a predefined antigen ratio

experimental: Group 4: RSV + HMPV Vaccine-Dose 4

Participants will receive RSV + HMPV vaccine corresponding to Dose 4 with a predefined antigen ratio

experimental: Group 5: RSV + HMPV Vaccine-Dose 5

Participants will receive RSV + HMPV vaccine corresponding to Dose 5 with a predefined antigen ratio

experimental: Group 6: RSV + HMPV Vaccine-Dose 6

Participants will receive RSV + HMPV vaccine corresponding to Dose 6 with a predefined antigen ratio

active comparator: Group 7: Control Vaccine 1

Participants will receive control vaccine 1

placebo comparator: Group 8: Placebo

Participants will receive Placebo

other: Group 9: Control Vaccine 2

Participants will receive control vaccine 2 at a predefined dose and antigen ratio

other: Group 10: Control Vaccine 3

Participants will receive control vaccine 3 at a predefined dose

other: Group 11: Control Vaccine 4

Participants will receive control vaccine 4 at a predefined dose

Interventions

RSV+HMPV vaccine

RSV + HMPV Candidate Vaccine

Control Vaccine 3

Control Vaccine 4

Control Vaccine 2

Placebo

Control Vaccine 1

Primary outcome measure

RSV A serum nAb (neutralizing antibodies) titers [ Time Frame: At Day 1 and Day 29 ]
RSV B serum nAb titers [ Time Frame: At Day 1 and Day 29 ]
HMPV A serum nAb titers [ Time Frame: At Day 1 and Day 29 ]
HMPV B serum nAb titers [ Time Frame: At Day 1 and Day 29 ]
Unsolicited systemic Adverse Events (AEs) that occur within 30 minutes after vaccination [ Time Frame: Within 30 minutes after vaccination ]
Presence of solicited injection site and systemic reactions [ Time Frame: For 8 days, including the day of vaccination ]
Presence of Unsolicited AEs [ Time Frame: For 28 days, including day of vaccination ]
Presence of medically attended AEs (MAAEs) [ Time Frame: Within 6 months after vaccination ]
Presence of Serious Adverse Events (SAEs), fatal SAEs and Adverse Events of Special Interest (AESIs) [ Time Frame: Throughout the study (approximately 12 months) ]
Presence of out-of-range biological test results [ Time Frame: At Day 09 ]

Central Contacts and Locations

Central contacts

Trial Transparency email recommended (Toll free for US & Canada)

800-633-1610 Contact-US@sanofi.com

Locations

Hawthorne Health - Gadsden City Pharmacy- Site Number : 8400025

Recruiting

Gadsden, Alabama, United States, 35901

Scottsdale Clinical Trials- Site Number : 8400011

Recruiting

Scottsdale, Arizona, United States, 85260

Long Beach Research Institute- Site Number : 8400005

Recruiting

Long Beach, California, United States, 90805

Alliance Clinical - San Diego- Site Number : 8400033

Recruiting

San Diego, California, United States, 92120

Accel Research Sites Network - DeLand Clinical Research Unit- Site Number : 8400064

Recruiting

DeLand, Florida, United States, 32720

Accel Research Sites - NeuroStudies- Site Number : 8400063

Recruiting

Decatur, Georgia, United States, 30030

DM Clinical Research - Chicago- Site Number : 8400050

Recruiting

Melrose Park, Illinois, United States, 60160

DM Clinical Research - Detroit- Site Number : 8400049

Recruiting

Southfield, Michigan, United States, 48076

Velocity Clinical Research - Lincoln - Valley Road- Site Number : 8400016

Recruiting

Lincoln, Nebraska, United States, 68510

Alliance Clinical - Las Vegas- Site Number : 8400034

Recruiting

Las Vegas, Nevada, United States, 89109

Hawthorne Health - Staten Island- Site Number : 8400026

Recruiting

Staten Island, New York, United States, 10309

DM Clinical Research - Philadelphia- Site Number : 8400046

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Coastal Carolina Research Center - North Charleston- Site Number : 8400061

Recruiting

North Charleston, South Carolina, United States, 29405

Velocity Clinical Research - Austin- Site Number : 8400013

Recruiting

Austin, Texas, United States, 78759

DM Clinical Research - Sugar Land- Site Number : 8400048

Recruiting

Sugar Land, Texas, United States, 77478

DM Clinical Research - Tomball- Site Number : 8400045

Recruiting

Tomball, Texas, United States, 77375

Charlottesville Medical Research- Site Number : 8400062

Recruiting

Charlottesville, Virginia, United States, 22911

More Information

Sponsor

Sanofi

Last update posted

Jul 29, 2026

Last verified

Jul, 2026

Keywords

RSV
HMPV

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Sanofi on 2026-07-29.