RSV+HMPV protein shot for adults 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 2b, observer-blind, randomized, placebo-controlled study to evaluate a bivalent RSV+HMPV protein vaccine in adults 60 years and older. It includes a Safety Lead-in with 200 participants to assess initial safety before expanding to the main cohort. About 8,000 participants total will be randomized to receive one intramuscular injection of the vaccine or placebo, with efficacy, safety, and immunogenicity data collected. The trial uses a parallel design and a case-driven approach to determine proof of concept. Locations include sites in Australia (Brisbane/NSW regions) with Sanofi as lead sponsor.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Aged 60 years or older on the day of inclusion
* Participants who, as determined by medical evaluation including medical history, physical examination, and clinical judgment of the Investigator are eligible for inclusion

Exclusion Criteria:

* Known/suspected immunodeficiency; immunosuppressive therapy/immunomodulators in past 6 months; long-term systemic corticosteroids (eg, prednisone for more than 2 weeks in past 3 months); history of immune-mediated neurological disease. Of note, persons living with stable HIV are not excluded
* Known systemic hypersensitivity to any of the study intervention components or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances
* 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 (GBS)
* Previous vaccination against RSV and/or HMPV (with a licensed or investigational vaccine either as a monovalent vaccine or any combination of the antigens) or previous receipt of RSV and/or HMPV monoclonal antibody

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Where it's running

• Investigational Site Number : 0360008
  Bruse, Australian Capital Territory, Australia Recruiting
• Investigational Site Number : 0360006
  Blacktown, New South Wales, Australia Recruiting
• Investigational Site Number : 0360007
  Maroubra, New South Wales, Australia Recruiting
• Investigational Site Number : 0360002
  Albion, Queensland, Australia Recruiting
• Investigational Site Number : 0360003
  Sippy Downs, Queensland, Australia Recruiting
• Investigational Site Number : 0360009
  Melbourne, Victoria, Australia 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.