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Phase 1/2 Study of Respiratory Syncytial Virus and Human Metapneumovirus (RSV+HMPV) Vaccine Candidate in Adults 60 Years of Age and Older
Sponsor: Sanofi
Summary
This study is a Phase 1/2, randomized, observer-blind, active and placebo-controlled, multi-center study to be conducted in approximately 2400 adults 60 years of age and older. The aim of the study is to evaluate the immunogenicity and safety of an RSV+HMPV vaccine candidate for the prevention of RSV and HMPV disease among adults 60 years of age and older. While there are 3 FDA approved/licensed RSV vaccines currently available to the public, no vaccine is available for the prevention of HMPV in older adults. This study is intended to provide data in support of further clinical development of the RSV+HMPV vaccine candidate. The study will consist of 4 cohorts and 11 vaccine groups (RSV+HMPV \[6 dose levels\], placebo and 4 control groups). The duration of the study will be approximately 12 months for each participant.
Official title: A Phase 1/2, Randomized, Controlled, Observer-Blind Study in Adults 60 Years of Age and Older to Evaluate the Immunogenicity and Safety of Different Dose Levels of a Bivalent Vaccine Candidate Against Respiratory Syncytial Virus (RSV) and Human Metapneumovirus (HMPV)
Key Details
Gender
All
Age Range
60 Years - Any
Study Type
INTERVENTIONAL
Enrollment
2400
Start Date
2026-07-22
Completion Date
2028-05-03
Last Updated
2026-07-29
Healthy Volunteers
Yes
Conditions
Interventions
RSV+HMPV vaccine
RSV + HMPV Candidate Vaccine
Control Vaccine 3
Control Vaccine 3
Control Vaccine 4
Control Vaccine 4
Control Vaccine 2
Control Vaccine 2
Placebo
Placebo
Control Vaccine 1
Control Vaccine 1
Locations (17)
Hawthorne Health - Gadsden City Pharmacy- Site Number : 8400025
Gadsden, Alabama, United States
Scottsdale Clinical Trials- Site Number : 8400011
Scottsdale, Arizona, United States
Long Beach Research Institute- Site Number : 8400005
Long Beach, California, United States
Alliance Clinical - San Diego- Site Number : 8400033
San Diego, California, United States
Accel Research Sites Network - DeLand Clinical Research Unit- Site Number : 8400064
DeLand, Florida, United States
Accel Research Sites - NeuroStudies- Site Number : 8400063
Decatur, Georgia, United States
DM Clinical Research - Chicago- Site Number : 8400050
Melrose Park, Illinois, United States
DM Clinical Research - Detroit- Site Number : 8400049
Southfield, Michigan, United States
Velocity Clinical Research - Lincoln - Valley Road- Site Number : 8400016
Lincoln, Nebraska, United States
Alliance Clinical - Las Vegas- Site Number : 8400034
Las Vegas, Nevada, United States
Hawthorne Health - Staten Island- Site Number : 8400026
Staten Island, New York, United States
DM Clinical Research - Philadelphia- Site Number : 8400046
Philadelphia, Pennsylvania, United States
Coastal Carolina Research Center - North Charleston- Site Number : 8400061
North Charleston, South Carolina, United States
Velocity Clinical Research - Austin- Site Number : 8400013
Austin, Texas, United States
DM Clinical Research - Sugar Land- Site Number : 8400048
Sugar Land, Texas, United States
DM Clinical Research - Tomball- Site Number : 8400045
Tomball, Texas, United States
Charlottesville Medical Research- Site Number : 8400062
Charlottesville, Virginia, United States