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Clinical Trials in the UK / NCT07810010
Recruiting Phase 2

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

NCT07810010 · tracked via the Priya Life Science UK tracker
Sponsor
Sanofi
Phase
Phase 2
Started
2026-09-09
Last updated
2026-10-19

Condition(s) studied

Respiratory Syncytial VirusHuman MetapneumovirusHealthy Volunteers

Investigational drug(s) / intervention(s)

Bivalent RSV+HMPV protein vaccinePlacebo

Bivalent RSV+HMPV protein vaccine: IM injection

Placebo: IM injection

Study summary

Study VCA25397 is a Phase 2b, observer-blind, randomized, placebo-controlled, parallel, case-driven proof of concept study that will enroll approximately 8000 adults aged 60 years and older to assess the clinical efficacy, safety, and immunogenicity of a single IM (intramuscular) injection of the bivalent RSV+HMPV protein vaccine candidate.

The study will include a Safety Lead-in Cohort that will be enrolled first and will comprise 200 participants aged 60 years and older randomized in a 1:1 ratio to receive either RSV+HMPV protein vaccine or placebo (100 participants per arm).

The enrollment of the Main Cohort will start after the completion of the ESDR (Early Safety Data Review), pending a positive outcome. For the Main Cohort, 7800 participants (3900 participants per arm) will be randomized in a 1:1 ratio to receive either RSV+HMPV protein vaccine or placebo.

Eligibility

Sex
ALL
Min age
60 Years
Max age
—
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Occurrence of the first episode of RSV-LRTD (Lower Respiratory Tract Disease) — From 14 days to 12 months after vaccination
  • Occurrence of the first episode of HMPV-LRTD — From 14 days to 12 months after vaccination

Trial sites (21)

FacilityCityRegionStatus
Investigational Site Number : 0360008 Bruse Australian Capital Territory Recruiting
Investigational Site Number : 0360006 Blacktown New South Wales Recruiting
Investigational Site Number : 0360007 Maroubra New South Wales Recruiting
Investigational Site Number : 0360002 Albion Queensland Recruiting
Investigational Site Number : 0360003 Sippy Downs Queensland Recruiting
Investigational Site Number : 0360009 Melbourne Victoria Recruiting
Investigational Site Number : 8260012 Cardiff Cardiff [Caerdydd Gb-crd] Recruiting
Investigational Site Number : 8261010 Bournemouth Dorset Recruiting
Investigational Site Number : 8263010 Dorchester Dorset Recruiting
Investigational Site Number : 8260013 London England Recruiting
Investigational Site Number : 8260011 London England Recruiting
Investigational Site Number : 8262010 Portsmouth Hampshire Recruiting
Investigational Site Number : 8260002 Blackpool Lancashire Recruiting
Investigational Site Number : 8260007 London London, City of Recruiting
Investigational Site Number : 8260001 Corby Northamptonshire Recruiting
Investigational Site Number : 8260005 Witney Oxfordshire Recruiting
Investigational Site Number : 8260009 Bromborough Wirral Recruiting
Investigational Site Number : 8260006 West Kirby Wirral Recruiting
Investigational Site Number : 8260003 Bradford United Kingdom Recruiting
Investigational Site Number : 8260004 London United Kingdom Recruiting
Investigational Site Number : 8260008 Stockton-on-Tees United Kingdom Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07810010 on ClinicalTrials.gov ↗ ← All trials in the UK