RSV+HMPV vaccine candidate in adults aged 60 and older

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 is a phase 1/2, randomized, observer-blind, multi-center study enrolling about 2,400 adults aged 60 and above. Participants receive the RSV+HMPV vaccine at multiple dose levels, a placebo, or other control vaccines, with several vaccine groups and control groups included. The study aims to measure immune response and safety over roughly 12 months per participant. The trial is conducted at sites in Alabama and California under Sanofi sponsorship. Eligibility requires age 60+, non-childbearing status, and absence of recent RSV/HMPV infection or certain cardiac and neurologic conditions that could affect safety or results.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hawthorne Health - Gadsden- Site Number : 8400025
  Gadsden, Alabama, United States Recruiting
• Accel Research Sites Network - Birmingham- Site Number : 8400065
  Vestavia Hills, Alabama, United States Recruiting
• Marvel Clinical Research- Site Number : 8400006
  Huntington Beach, California, United States Recruiting
• Velocity Clinical Research - San Diego- Site Number : 8400019
  La Mesa, California, United States Recruiting
• Long Beach Research Institute- Site Number : 8400005
  Long Beach, California, United States Recruiting
• Acclaim Clinical Research- Site Number : 8400033
  San Diego, 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

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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.