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NCT07734649PHASE1, PHASE2RecruitingAccepts Healthy Volunteers

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

Sanofi

Start Date

7/22/2026

Completion Date

5/3/2028

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.

Eligibility Criteria

Age Range: 60 years to No maximum

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.

Interventions

BIOLOGICAL

RSV+HMPV vaccine

BIOLOGICAL

Control Vaccine 3

BIOLOGICAL

Control Vaccine 4

BIOLOGICAL

Control Vaccine 2

OTHER

Placebo

BIOLOGICAL

Control Vaccine 1

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Conditions

Respiratory Syncytial Virus ImmunizationHuman Metapneumovirus ImmunizationHealthy Volunteers

Locations

Hawthorne Health - Gadsden City Pharmacy- Site Number : 8400025

Gadsden, Alabama 35901

United States

Scottsdale Clinical Trials- Site Number : 8400011

Scottsdale, Arizona 85260

United States

Long Beach Research Institute- Site Number : 8400005

Long Beach, California 90805

United States

Alliance Clinical - San Diego- Site Number : 8400033

San Diego, California 92120

United States

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

DeLand, Florida 32720

United States

Accel Research Sites - NeuroStudies- Site Number : 8400063

Decatur, Georgia 30030

United States

DM Clinical Research - Chicago- Site Number : 8400050

Melrose Park, Illinois 60160

United States

DM Clinical Research - Detroit- Site Number : 8400049

Southfield, Michigan 48076

United States

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

Lincoln, Nebraska 68510

United States

Alliance Clinical - Las Vegas- Site Number : 8400034

Las Vegas, Nevada 89109

United States

Hawthorne Health - Staten Island- Site Number : 8400026

Staten Island, New York 10309

United States

DM Clinical Research - Philadelphia- Site Number : 8400046

Philadelphia, Pennsylvania 19107

United States

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

North Charleston, South Carolina 29405

United States

Velocity Clinical Research - Austin- Site Number : 8400013

Austin, Texas 78759

United States

DM Clinical Research - Sugar Land- Site Number : 8400048

Sugar Land, Texas 77478

United States

DM Clinical Research - Tomball- Site Number : 8400045

Tomball, Texas 77375

United States

Charlottesville Medical Research- Site Number : 8400062

Charlottesville, Virginia 22911

United States