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.
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
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)
Parallel
Bivalent RSV+HMPV protein vaccine
Biological/VaccineIM injection
Placebo
Biological/VaccineIM injection
Occurrence of the first episode of RSV-LRTD (Lower Respiratory Tract Disease)
Occurrence of the first episode of HMPV-LRTD
Occurrence of the first episode of RSV-LRTD and/or HMPV-LRTD
Occurrence of the first episode of RSV-ARD (Acute Respiratory Disease) and/or HMPV-ARD
Occurrence of the first episode of severe RSV-LRTD and/or severe HMPV-LRTD
Occurrence of the first episode of RSV-URTD and/or HMPV-URTD
