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RecruitingAccepts healthy volunteersPhase 1/Phase 2

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

Sanofi · NCT07734649

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 60+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 1, Phase 2
Target enrollment
2400
US sites recruiting
50
Study start
July 22, 2026
Record last updated
October 14, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: RSV+HMPV vaccine; Control Vaccine 3; Control Vaccine 4; Control Vaccine 2; Placebo; Control Vaccine 1

Conditions: Respiratory Syncytial Virus Immunization; Human Metapneumovirus Immunization; Healthy Volunteers

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • Hawthorne Health - Gadsden- Site Number : 8400025

    Gadsden, AL 35901

  • Accel Research Sites Network - Birmingham- Site Number : 8400065

    Vestavia Hills, AL 35216

  • Marvel Clinical Research- Site Number : 8400006

    Huntington Beach, CA 92647

  • Velocity Clinical Research - San Diego- Site Number : 8400019

    La Mesa, CA 91942

  • Long Beach Research Institute- Site Number : 8400005

    Long Beach, CA 90805

  • Acclaim Clinical Research- Site Number : 8400033

    San Diego, CA 92120

  • Velocity Clinical Research - Washington DC- Site Number : 8400021

    Washington D.C., DC 20016

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

    DeLand, FL 32720

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

    Edgewater, FL 32132

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

    Lakeland, FL 33803

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

    Largo, FL 33777

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

    Maitland, FL 32751

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

    Palmetto Bay, FL 33157

  • Accel Research Sites - NeuroStudies- Site Number : 8400063

    Decatur, GA 30030

  • North Georgia Clinical Research- Site Number : 8400078

    Woodstock, GA 30189

  • DM Clinical Research - Chicago- Site Number : 8400050

    Melrose Park, IL 60160

  • Enspire Clinical Research- Site Number : 8400077

    Peoria, IL 61614

  • DM Clinical Research - Indianapolis- Site Number : 8400082

    Indianapolis, IN 46254

  • Velocity Clinical Research - New Orleans- Site Number : 8400022

    New Orleans, LA 70119

  • Boston Clinical Trials- Site Number : 8400070

    Boston, MA 02131

  • DM Clinical Research - Brookline- Site Number : 8400055

    Brookline, MA 02446

  • ActivMed Practices & Research - Methuen- Site Number : 8400066

    Methuen, MA 01844

  • QUEST Research Institute- Site Number : 8400068

    Farmington Hills, MI 48334

  • DM Clinical Research - Detroit- Site Number : 8400049

    Southfield, MI 48076

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

    Lincoln, NE 68510

  • Velocity Clinical Research - Omaha- Site Number : 8400012

    Omaha, NE 68134

  • Alliance Clinical - Las Vegas- Site Number : 8400034

    Las Vegas, NV 89109

  • DM Clinical Research - New Jersey- Site Number : 8400044

    Jersey City, NJ 07306

  • Hawthorne - Bienstar Lindenwold- Site Number : 8400027

    Lindenwold, NJ 08021

  • DM Clinical Research - Albuquerque- Site Number : 8400051

    Albuquerque, NM 87106

  • Hawthorne Health - Staten Island- Site Number : 8400026

    Staten Island, NY 10309

  • Velocity Clinical Research - Cleveland- Site Number : 8400024

    Beachwood, OH 44122

  • Velocity Clinical Research - Springdale- Site Number : 8400014

    Cincinnati, OH 45246

  • DM Clinical Research - Philadelphia- Site Number : 8400046

    Philadelphia, PA 19107

  • Velocity Clinical Research - Providence- Site Number : 8400018

    East Greenwich, RI 02818

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

    North Charleston, SC 29405

  • Velocity Clinical Research - Austin- Site Number : 8400013

    Austin, TX 78759

  • Zenos Clinical Research- Site Number : 8400032

    Dallas, TX 75230

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

    Houston, TX 77065

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

    Houston, TX 77081

  • DM Clinical Research - Dallas- Site Number : 8400059

    Irving, TX 75061

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

    San Antonio, TX 78207

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

    San Antonio, TX 78207

  • DM Clinical Research - Sugar Land- Site Number : 8400048

    Sugar Land, TX 77478

  • Olympus Clinical Research - Sugar Land- Site Number : 8400071

    Sugar Land, TX 77478

  • DM Clinical Research - Tomball- Site Number : 8400045

    Tomball, TX 77375

  • DM Clinical Research - Tomball- Site Number : 8400081

    Tomball, TX 77375

  • Charlottesville Medical Research- Site Number : 8400062

    Charlottesville, VA 22911

  • Velocity Clinical Research - Hampton- Site Number : 8400015

    Hampton, VA 23666

  • Dm Clinical - Seattle- Site Number : 8400047

    Seattle, WA 98122

Study contacts (from the official record)

  • Trial Transparency email recommended (Toll free for US & Canada) · 800-633-1610 · Contact-US@sanofi.com
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Phase 1/2 Study of Respiratory Syncytial Virus and Human… (NCT07734649) | Bored Studies