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RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

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

Sponsor: Sanofi • ClinicalTrials.gov ID: NCT07734649

Registry updated: 2026-10-14
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Description

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.

Interventions

  • RSV+HMPV vaccine (Biological)
    RSV + HMPV Candidate Vaccine
  • Control Vaccine 3 (Biological)
    Control Vaccine 3
  • Control Vaccine 4 (Biological)
    Control Vaccine 4
  • Control Vaccine 2 (Biological)
    Control Vaccine 2
  • Placebo (Other)
    Placebo
  • Control Vaccine 1 (Biological)
    Control Vaccine 1

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.

Conditions

Respiratory Syncytial Virus Immunization Human Metapneumovirus Immunization Healthy Volunteers

Locations

  • Hawthorne Health - Gadsden- Site Number : 8400025 — Gadsden, Alabama, United States
  • Accel Research Sites Network - Birmingham- Site Number : 8400065 — Vestavia Hills, Alabama, United States
  • Marvel Clinical Research- Site Number : 8400006 — Huntington Beach, California, United States
  • Velocity Clinical Research - San Diego- Site Number : 8400019 — La Mesa, California, United States
  • Long Beach Research Institute- Site Number : 8400005 — Long Beach, California, United States
  • Acclaim Clinical Research- Site Number : 8400033 — San Diego, California, United States
  • Velocity Clinical Research - Washington DC- Site Number : 8400021 — Washington D.C., District of Columbia, United States
  • Accel Research Sites Network - DeLand Clinical Research Unit- Site Number : 8400064 — DeLand, Florida, United States
  • Velocity Clinical Research - New Smyrna Beach- Site Number : 8400017 — Edgewater, Florida, United States
  • Accel Research Sites - Lakeland Clinical Research Unit- Site Number : 8400073 — Lakeland, Florida, United States
  • Accel Research Sites - St. Petersburg - Largo- Site Number : 8400067 — Largo, Florida, United States
  • Accel Research Sites - Maitland Clinical Research Unit- Site Number : 8400074 — Maitland, Florida, United States
  • Alcanza - Innovation Medical Research Center - Palmetto- Site Number : 8400069 — Palmetto Bay, Florida, United States
  • Accel Research Sites - NeuroStudies- Site Number : 8400063 — Decatur, Georgia, United States
  • North Georgia Clinical Research- Site Number : 8400078 — Woodstock, Georgia, United States
  • DM Clinical Research - Chicago- Site Number : 8400050 — Melrose Park, Illinois, United States
  • Enspire Clinical Research- Site Number : 8400077 — Peoria, Illinois, United States
  • DM Clinical Research - Indianapolis- Site Number : 8400082 — Indianapolis, Indiana, United States
  • Velocity Clinical Research - New Orleans- Site Number : 8400022 — New Orleans, Louisiana, United States
  • Boston Clinical Trials- Site Number : 8400070 — Boston, Massachusetts, United States
  • DM Clinical Research - Brookline- Site Number : 8400055 — Brookline, Massachusetts, United States
  • ActivMed Practices & Research - Methuen- Site Number : 8400066 — Methuen, Massachusetts, United States
  • QUEST Research Institute- Site Number : 8400068 — Farmington Hills, Michigan, United States
  • DM Clinical Research - Detroit- Site Number : 8400049 — Southfield, Michigan, United States
  • Velocity Clinical Research - Lincoln - Valley Road- Site Number : 8400016 — Lincoln, Nebraska, United States
  • Velocity Clinical Research - Omaha- Site Number : 8400012 — Omaha, Nebraska, United States
  • Alliance Clinical - Las Vegas- Site Number : 8400034 — Las Vegas, Nevada, United States
  • DM Clinical Research - New Jersey- Site Number : 8400044 — Jersey City, New Jersey, United States
  • Hawthorne - Bienstar Lindenwold- Site Number : 8400027 — Lindenwold, New Jersey, United States
  • DM Clinical Research - Albuquerque- Site Number : 8400051 — Albuquerque, New Mexico, United States
  • Hawthorne Health - Staten Island- Site Number : 8400026 — Staten Island, New York, United States
  • Velocity Clinical Research - Cleveland- Site Number : 8400024 — Beachwood, Ohio, United States
  • Velocity Clinical Research - Springdale- Site Number : 8400014 — Cincinnati, Ohio, United States
  • DM Clinical Research - Philadelphia- Site Number : 8400046 — Philadelphia, Pennsylvania, United States
  • Velocity Clinical Research - Providence- Site Number : 8400018 — East Greenwich, Rhode Island, United States
  • Coastal Carolina Research Center - North Charleston- Site Number : 8400061 — North Charleston, South Carolina, United States
  • Velocity Clinical Research - Austin- Site Number : 8400013 — Austin, Texas, United States
  • Zenos Clinical Research- Site Number : 8400032 — Dallas, Texas, United States
  • DM Clinical Research - CyFair Clinical Research Center- Site Number : 8400058 — Houston, Texas, United States
  • Texas Center for Drug Development - Houston- Site Number : 8400043 — Houston, Texas, United States
  • DM Clinical Research - Dallas- Site Number : 8400059 — Irving, Texas, United States
  • DM Clinical Research - San Antonio - North San Saba- Site Number : 8400056 — San Antonio, Texas, United States
  • DM Clinical Research - San Antonio - North San Saba- Site Number : 8400057 — San Antonio, Texas, United States
  • DM Clinical Research - Sugar Land- Site Number : 8400048 — Sugar Land, Texas, United States
  • Olympus Clinical Research - Sugar Land- Site Number : 8400071 — Sugar Land, Texas, United States
  • DM Clinical Research - Tomball- Site Number : 8400045 — Tomball, Texas, United States
  • DM Clinical Research - Tomball- Site Number : 8400081 — Tomball, Texas, United States
  • Charlottesville Medical Research- Site Number : 8400062 — Charlottesville, Virginia, United States
  • Velocity Clinical Research - Hampton- Site Number : 8400015 — Hampton, Virginia, United States
  • Dm Clinical - Seattle- Site Number : 8400047 — Seattle, Washington, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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