Phase 1/2 Study of Respiratory Syncytial Virus and Human Metapneumovirus (RSV+HMPV) Vaccine Candidate in Adults 60 Years of Age and Older
A Phase 1/2, Randomized, Controlled, Observer-Blind Study in Adults 60 Years of Age and Older to Evaluate the Immunogenicity and Safety of Different Dose Levels of a Bivalent Vaccine Candidate Against Respiratory Syncytial Virus (RSV) and Human Metapneumovirus (HMPV)
- Respiratory Syncytial Virus Immunization
- Human Metapneumovirus Immunization
- Healthy Volunteers
At a glance
- Phase
- Phase 1
- Study type
- Interventional
- Sponsor
- Sanofi
- Enrolment target
- 2,400
- Started
- 22 July 2026
- Main results due
- 3 May 2028
- Study sites
- 50
- Registry updated
- 24 September 2026
Can you take part?
- Aged 60 years and over.
- Open to any sex.
- Healthy volunteers can take part.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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.
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(50)
Hawthorne Health - Gadsden- Site Number : 8400025
Gadsden, Alabama, United States
Recruiting
Accel Research Sites Network - Birmingham- Site Number : 8400065
Vestavia Hills, Alabama, United States
Recruiting
Marvel Clinical Research- Site Number : 8400006
Huntington Beach, California, United States
Recruiting
Velocity Clinical Research - San Diego- Site Number : 8400019
La Mesa, California, United States
Recruiting
Long Beach Research Institute- Site Number : 8400005
Long Beach, California, United States
Recruiting
Acclaim Clinical Research- Site Number : 8400033
San Diego, California, United States
Recruiting
Velocity Clinical Research - Washington DC- Site Number : 8400021
Washington D.C., District of Columbia, United States
Recruiting
Accel Research Sites Network - DeLand Clinical Research Unit- Site Number : 8400064
DeLand, Florida, United States
Recruiting
Velocity Clinical Research - New Smyrna Beach- Site Number : 8400017
Edgewater, Florida, United States
Recruiting
Accel Research Sites - Lakeland Clinical Research Unit- Site Number : 8400073
Lakeland, Florida, United States
Recruiting
Accel Research Sites - St. Petersburg - Largo- Site Number : 8400067
Largo, Florida, United States
Recruiting
Accel Research Sites - Maitland Clinical Research Unit- Site Number : 8400074
Maitland, Florida, United States
Recruiting
Alcanza - Innovation Medical Research Center - Palmetto- Site Number : 8400069
Palmetto Bay, Florida, United States
Recruiting
Accel Research Sites - NeuroStudies- Site Number : 8400063
Decatur, Georgia, United States
Recruiting
North Georgia Clinical Research- Site Number : 8400078
Woodstock, Georgia, United States
Recruiting
DM Clinical Research - Chicago- Site Number : 8400050
Melrose Park, Illinois, United States
Recruiting
Enspire Clinical Research- Site Number : 8400077
Peoria, Illinois, United States
Recruiting
DM Clinical Research - Indianapolis- Site Number : 8400082
Indianapolis, Indiana, United States
Recruiting
Velocity Clinical Research - New Orleans- Site Number : 8400022
New Orleans, Louisiana, United States
Recruiting
Boston Clinical Trials- Site Number : 8400070
Boston, Massachusetts, United States
Recruiting
DM Clinical Research - Brookline- Site Number : 8400055
Brookline, Massachusetts, United States
Recruiting
ActivMed Practices & Research - Methuen- Site Number : 8400066
Methuen, Massachusetts, United States
Recruiting
QUEST Research Institute- Site Number : 8400068
Farmington Hills, Michigan, United States
Recruiting
DM Clinical Research - Detroit- Site Number : 8400049
Southfield, Michigan, United States
Recruiting
Velocity Clinical Research - Lincoln - Valley Road- Site Number : 8400016
Lincoln, Nebraska, United States
Recruiting
Velocity Clinical Research - Omaha- Site Number : 8400012
Omaha, Nebraska, United States
Recruiting
Alliance Clinical - Las Vegas- Site Number : 8400034
Las Vegas, Nevada, United States
Recruiting
DM Clinical Research - New Jersey- Site Number : 8400044
Jersey City, New Jersey, United States
Recruiting
Hawthorne - Bienstar Lindenwold- Site Number : 8400027
Lindenwold, New Jersey, United States
Recruiting
DM Clinical Research - Albuquerque- Site Number : 8400051
Albuquerque, New Mexico, United States
Recruiting
Hawthorne Health - Staten Island- Site Number : 8400026
Staten Island, New York, United States
Recruiting
Velocity Clinical Research - Cleveland- Site Number : 8400024
Beachwood, Ohio, United States
Recruiting
Velocity Clinical Research - Springdale- Site Number : 8400014
Cincinnati, Ohio, United States
Recruiting
DM Clinical Research - Philadelphia- Site Number : 8400046
Philadelphia, Pennsylvania, United States
Recruiting
Velocity Clinical Research - Providence- Site Number : 8400018
East Greenwich, Rhode Island, United States
Recruiting
Coastal Carolina Research Center - North Charleston- Site Number : 8400061
North Charleston, South Carolina, United States
Recruiting
Velocity Clinical Research - Austin- Site Number : 8400013
Austin, Texas, United States
Recruiting
Zenos Clinical Research- Site Number : 8400032
Dallas, Texas, United States
Recruiting
DM Clinical Research - CyFair Clinical Research Center- Site Number : 8400058
Houston, Texas, United States
Recruiting
Texas Center for Drug Development - Houston- Site Number : 8400043
Houston, Texas, United States
Recruiting
DM Clinical Research - Dallas- Site Number : 8400059
Irving, Texas, United States
Recruiting
DM Clinical Research - San Antonio - North San Saba- Site Number : 8400056
San Antonio, Texas, United States
Recruiting
DM Clinical Research - San Antonio - North San Saba- Site Number : 8400057
San Antonio, Texas, United States
Recruiting
DM Clinical Research - Sugar Land- Site Number : 8400048
Sugar Land, Texas, United States
Recruiting
Olympus Clinical Research - Sugar Land- Site Number : 8400071
Sugar Land, Texas, United States
Recruiting
DM Clinical Research - Tomball- Site Number : 8400045
Tomball, Texas, United States
Recruiting
DM Clinical Research - Tomball- Site Number : 8400081
Tomball, Texas, United States
Recruiting
Charlottesville Medical Research- Site Number : 8400062
Charlottesville, Virginia, United States
Recruiting
Velocity Clinical Research - Hampton- Site Number : 8400015
Hampton, Virginia, United States
Recruiting
Dm Clinical - Seattle- Site Number : 8400047
Seattle, Washington, United States
Recruiting
Showing 50 of 50 sites. 50 of the 50 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07734649. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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