Study of a Respiratory Syncytial Virus/Human Metapneumovirus Vaccine Candidate

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Respiratory Syncytial Virus Infection, Healthy Volunteers, Human Metapneumovirus

In brief

The purpose of this study is to assess the safety and immunogenicity of a single intramuscular (IM) injection of different doses of an respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) vaccine candidate, in adult participants aged 60 years and older. In addition, the study will evaluate the safety and immunogenicity of a booster vaccination administered 12 months after the primary vaccination in a subset of the study population.

Key facts

Study ID

NCT06134648

Run by

Sanofi Pasteur, a Sanofi Company

People needed

646

Starts

2023-11-01

Expected to finish

2026-02-27

Last updated by the study team

2026-03-12

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Aged 60 years or older on the day of inclusion
• A female participant is eligible to participate if she is not pregnant or breastfeeding and is of non-childbearing potential.
• Participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion Note: Participants with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included.

You may not qualify if…

• Participants are excluded from the study if any of the following criteria apply:
• Any screening laboratory parameter with laboratory abnormalities deemed clinically significant by the investigator
• Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy. Persons living with stable human immunodeficiency virus (HIV) are not excluded
• Known systemic hypersensitivity to any of the study intervention components (eg, polyethylene glycol, polysorbate); history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances; any allergic reaction (eg, anaphylaxis) after administration of mRNA coronavirus disease 2019 (COVID-19) vaccine
• History of RSV and/or hMPV-associated illness, diagnosed clinically, serologically, or microbiologically in the last 12 months
• Previous history of myocarditis, pericarditis, and/or myopericarditis
• Screening electrocardiogram 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
• Thrombocytopenia or bleeding disorder, contraindicating intramuscular (IM) injection based on investigator's judgment
• Receipt of anticoagulants in the 3 weeks preceding inclusion
• Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
• Alcohol, prescription drug, or substance abuse that, in the opinion of the investigator, might interfere with the study conduct or completion
• History of acute infection symptoms or a positive severe acute respiratory syndrome coronavirus reverse transcription polymerase chain reaction (SARS-CoV-2 RT-PCR) or antigen test in the 10 days prior to the visit. A prospective participant should not be included in the study until the condition has resolved
• Receipt of any vaccine other than mRNA vaccine in the 4 weeks preceding any study intervention administration or planned receipt of any vaccine other than mRNA vaccine in the 4 weeks following any study intervention administration
• Receipt of any mRNA vaccine in the 60 days preceding any study intervention administration or planned receipt of any mRNA vaccine in the 60 days following any study intervention administration
• Previous vaccination against RSV and/or hMPV (with a licensed or investigational vaccine either as a monovalent vaccine or any combination of the antigens)
• Receipt of immune globulins, blood, or blood-derived products in the past 3 months
• Participation at the time of study enrollment (or in the 4 weeks preceding the first study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Where it is running

• Collaborative Neuroscience Research Site Number : 8400017 — Los Alamitos, California, United States
• Matrix Clinical Research Site Number : 8400011 — Los Angeles, California, United States
• Peninsula Research Associates Site Number : 8400001 — Rolling Hills Estates, California, United States
• Suncoast Research Associates, LLC Site Number : 8400002 — Miami, Florida, United States
• AMR Chicago, Oakbrook Terrace Site Number : 8400019 — Oakbrook Terrace, Illinois, United States
• Velocity Clinical Research, Sioux City Site Number : 8400012 — Sioux City, Iowa, United States
• AMR Lexington Site Number : 8400008 — Lexington, Kentucky, United States
• AMR Kansas City Site Number : 8400014 — Kansas City, Missouri, United States
• AMR Knoxville Site Number : 8400010 — Knoxville, Tennessee, United States
• DM Clinical Research - Tomball Site Number : 8400004 — Tomball, Texas, United States
• Investigational Site Number : 6300002 — Guayama, Puerto Rico
• Investigational Site Number : 6300001 — San Juan, Puerto Rico
• Investigational Site Number : 6300003 — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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