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.
Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Contact-US@sanofi.com
Observer-blind:
Participants will receive RSV + HMPV vaccine corresponding to Dose 1 with a predefined antigen ratio
Participants will receive RSV + HMPV vaccine corresponding to Dose 2 with a predefined antigen ratio
Participants will receive RSV + HMPV vaccine corresponding to Dose 3 with a predefined antigen ratio
Participants will receive RSV + HMPV vaccine corresponding to Dose 4 with a predefined antigen ratio
Participants will receive RSV + HMPV vaccine corresponding to Dose 5 with a predefined antigen ratio
Participants will receive RSV + HMPV vaccine corresponding to Dose 6 with a predefined antigen ratio
Participants will receive control vaccine 1
Participants will receive Placebo
Participants will receive control vaccine 2 at a predefined dose and antigen ratio
Participants will receive control vaccine 3 at a predefined dose
Participants will receive control vaccine 4 at a predefined dose
Gadsden, Alabama 35901, United States
Long Beach, California 90805, United States
San Diego, California 92120, United States
DeLand, Florida 32720, United States
Decatur, Georgia 30030, United States
Melrose Park, Illinois 60160, United States
Southfield, Michigan 48076, United States
Lincoln, Nebraska 68510, United States
Las Vegas, Nevada 89109, United States
Staten Island, New York 10309, United States
Philadelphia, Pennsylvania 19107, United States
North Charleston, South Carolina 29405, United States
Austin, Texas 78759, United States
Sugar Land, Texas 77478, United States
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