Healthy Volunteers, Human Metapneumovirus, Respiratory Syncytial Virus
Conditions
Brief 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.
Interventions
BIOLOGICALBivalent RSV+HMPV protein vaccine
IM injection
BIOLOGICALPlacebo
IM injection
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of the first episode of RSV-LRTD and/or HMPV-LRTD | From 14 days to 12 months after vaccination |
| Occurrence of the first episode of RSV-ARD (Acute Respiratory Disease) and/or HMPV-ARD | From 14 days to 12 months after vaccination |
| Occurrence of the first episode of severe RSV-LRTD and/or severe HMPV-LRTD | From 14 days to 12 months after vaccination |
| Occurrence of the first episode of RSV-URTD and/or HMPV-URTD | From 14 days to 12 months after vaccination |
| RSV A, RSV B, and HMPV A, HMPV B serum nAb titers in a subset of participants | At pre-vaccination and 8 days, 28 days, 6 months and 12 months post- vaccination |
| Presence of immediate unsolicited systemic AEs (Adverse Events) | Within 30 minutes after vaccination |
| Presence of solicited injection site and systemic reactions in a subset of participants | Up to 7 days after vaccination |
| Presence of unsolicited AEs reported | Up to 27 days after vaccination |
| Presence of MAAEs (Medically Attended Adverse Events) | Within 6 months after vaccination |
| Presence of SAEs (Serious Adverse Events) and AESIs (Adverse Event of Special Interest) | Within 6 months after vaccination |
| Presence of related SAEs, related AESIs, and fatal SAEs | Up to 12 months post-vaccination |
| Presence of out-of-range biological test results in a subset of participants | 7 days after vaccination |
Countries
Australia, United Kingdom
Contacts
CONTACTTrial Transparency email recommended (Toll free for US & Canada)
Outcome results
None listed