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

Oct, 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) 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- Site Number : 8400025

Recruiting

Gadsden, Alabama, United States, 35901

Accel Research Sites Network - Birmingham- Site Number : 8400065

Recruiting

Vestavia Hills, Alabama, United States, 35216

Marvel Clinical Research- Site Number : 8400006

Recruiting

Huntington Beach, California, United States, 92647

Velocity Clinical Research - San Diego- Site Number : 8400019

Recruiting

La Mesa, California, United States, 91942

Long Beach Research Institute- Site Number : 8400005

Recruiting

Long Beach, California, United States, 90805

Acclaim Clinical Research- Site Number : 8400033

Recruiting

San Diego, California, United States, 92120

Velocity Clinical Research - Washington DC- Site Number : 8400021

Recruiting

Washington D.C., District of Columbia, United States, 20016

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

Recruiting

DeLand, Florida, United States, 32720

Velocity Clinical Research - New Smyrna Beach- Site Number : 8400017

Recruiting

Edgewater, Florida, United States, 32132

Accel Research Sites - Lakeland Clinical Research Unit- Site Number : 8400073

Recruiting

Lakeland, Florida, United States, 33803

Accel Research Sites - St. Petersburg - Largo- Site Number : 8400067

Recruiting

Largo, Florida, United States, 33777

Accel Research Sites - Maitland Clinical Research Unit- Site Number : 8400074

Recruiting

Maitland, Florida, United States, 32751

Alcanza - Innovation Medical Research Center - Palmetto- Site Number : 8400069

Recruiting

Palmetto Bay, Florida, United States, 33157

Accel Research Sites - NeuroStudies- Site Number : 8400063

Recruiting

Decatur, Georgia, United States, 30030

North Georgia Clinical Research- Site Number : 8400078

Recruiting

Woodstock, Georgia, United States, 30189

DM Clinical Research - Chicago- Site Number : 8400050

Recruiting

Melrose Park, Illinois, United States, 60160

Enspire Clinical Research- Site Number : 8400077

Recruiting

Peoria, Illinois, United States, 61614

DM Clinical Research - Indianapolis- Site Number : 8400082

Recruiting

Indianapolis, Indiana, United States, 46254

Velocity Clinical Research - New Orleans- Site Number : 8400022

Recruiting

New Orleans, Louisiana, United States, 70119

Boston Clinical Trials- Site Number : 8400070

Recruiting

Boston, Massachusetts, United States, 02131

DM Clinical Research - Brookline- Site Number : 8400055

Recruiting

Brookline, Massachusetts, United States, 02446

ActivMed Practices & Research - Methuen- Site Number : 8400066

Recruiting

Methuen, Massachusetts, United States, 01844

QUEST Research Institute- Site Number : 8400068

Recruiting

Farmington Hills, Michigan, United States, 48334

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

Velocity Clinical Research - Omaha- Site Number : 8400012

Recruiting

Omaha, Nebraska, United States, 68134

Alliance Clinical - Las Vegas- Site Number : 8400034

Recruiting

Las Vegas, Nevada, United States, 89109

DM Clinical Research - New Jersey- Site Number : 8400044

Recruiting

Jersey City, New Jersey, United States, 07306

Hawthorne - Bienstar Lindenwold- Site Number : 8400027

Recruiting

Lindenwold, New Jersey, United States, 08021

DM Clinical Research - Albuquerque- Site Number : 8400051

Recruiting

Albuquerque, New Mexico, United States, 87106

Hawthorne Health - Staten Island- Site Number : 8400026

Recruiting

Staten Island, New York, United States, 10309

Velocity Clinical Research - Cleveland- Site Number : 8400024

Recruiting

Beachwood, Ohio, United States, 44122

Velocity Clinical Research - Springdale- Site Number : 8400014

Recruiting

Cincinnati, Ohio, United States, 45246

DM Clinical Research - Philadelphia- Site Number : 8400046

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Velocity Clinical Research - Providence- Site Number : 8400018

Recruiting

East Greenwich, Rhode Island, United States, 02818

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

Zenos Clinical Research- Site Number : 8400032

Recruiting

Dallas, Texas, United States, 75230

DM Clinical Research - CyFair Clinical Research Center- Site Number : 8400058

Recruiting

Houston, Texas, United States, 77065

Texas Center for Drug Development - Houston- Site Number : 8400043

Recruiting

Houston, Texas, United States, 77081

DM Clinical Research - Dallas- Site Number : 8400059

Recruiting

Irving, Texas, United States, 75061

DM Clinical Research - San Antonio - North San Saba- Site Number : 8400056

Recruiting

San Antonio, Texas, United States, 78207

DM Clinical Research - San Antonio - North San Saba- Site Number : 8400057

Recruiting

San Antonio, Texas, United States, 78207

DM Clinical Research - Sugar Land- Site Number : 8400048

Recruiting

Sugar Land, Texas, United States, 77478

Olympus Clinical Research - Sugar Land- Site Number : 8400071

Recruiting

Sugar Land, Texas, United States, 77478

DM Clinical Research - Tomball- Site Number : 8400045

Recruiting

Tomball, Texas, United States, 77375

DM Clinical Research - Tomball- Site Number : 8400081

Recruiting

Tomball, Texas, United States, 77375

Charlottesville Medical Research- Site Number : 8400062

Recruiting

Charlottesville, Virginia, United States, 22911

Velocity Clinical Research - Hampton- Site Number : 8400015

Recruiting

Hampton, Virginia, United States, 23666

Dm Clinical - Seattle- Site Number : 8400047

Recruiting

Seattle, Washington, United States, 98122

More Information

Sponsor

Sanofi

Last update posted

Oct 14, 2026

Last verified

Oct, 2026

Keywords

RSV
HMPV

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Sanofi on 2026-10-14. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.