Vaccine for preventing respiratory infections in older adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and immune response of a new mRNA vaccine designed to protect adults aged 60 and older from infections caused by human metapneumovirus (hMPV) and respiratory syncytial virus (RSV). Participants will receive either the investigational vaccine or a placebo, and the study will assess the vaccine's safety profile and its ability to generate an immune response. Additionally, a booster dose will be administered to a subset of participants 12 months after the initial vaccination to further evaluate its effectiveness. The study spans up to 12 months for some participants, allowing for comprehensive data collection on the vaccine's performance.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year or surgically sterile

Exclusion Criteria:

* Any screening laboratory parameter with laboratory abnormality \> Grade 1 deemed clinically significant by the investigator
* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months). Of note, 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 an mRNA vaccine
* History of RSV and/or hMPV-associated illness, diagnosed 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
* Laboratory-confirmed thrombocytopenia, contraindicating IM injection, based on investigator's judgment
* Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM injection, based on investigator's judgment
* Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
* Receipt of any vaccine other than mRNA vaccine in the 28 days preceding any study intervention administration or planned receipt of any vaccine other than mRNA vaccine in the 28 days 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

Note: The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Where it's running

• Velocity Clinical Research, Phoenix- Site Number : 8400025
  Phoenix, Arizona, United States Recruiting
• CenExel CNS-Garden Grove- Site Number : 8400017
  Garden Grove, California, United States Recruiting
• National Research Institute - Gardena- Site Number : 8400005
  Gardena, California, United States Recruiting
• National Research Institute - Huntington Park- Site Number : 8400014
  Huntington Park, California, United States Recruiting
• Velocity Clinical Research - San Diego- Site Number : 8400008
  La Mesa, California, United States Recruiting
• Velocity Clinical Research Los Angeles- Site Number : 8400013
  Los Angeles, California, United States Recruiting

Study contacts

• Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)
• Email: Contact-US@sanofi.com
• Phone: 800-633-1610

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.