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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 60 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Aged 60 years or older on the day of inclusion - Non-childbearing potential (ie, post-menopausal for at least 1 year or surgically sterile)

Exclusion Criteria

  • History of laboratory-confirmed RSV and/or laboratory-confirmed HMPV infection affecting the participant and/or the participant's household in the previous 12 months - Previous history of myocarditis, pericarditis, and/or myopericarditis - Screening electrocardiogram (ECG) that is consistent with possible myocarditis, pericarditis, and/or myopericarditis or, in the opinion of the investigator, demonstrates clinically relevant abnormalities that may affect participant safety or study results - 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-BarrĂ© Syndrome - Any vaccine given 4 weeks before or 4 weeks after study intervention - Previous vaccination against RSV and/or HMPV with an investigational or marketed vaccine - Receipt of any mRNA vaccine/product in the 2 months preceding study intervention administration - Has received a blood transfusion or blood-derived products, including immunoglobulins, in the past 3 months - Any screening laboratory parameter with laboratory abnormality > Grade 1 or deemed clinically significant by the investigator; if deemed appropriate, investigator may repeat these assessments The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
Observer-blind: - Blinding for vaccine group assignment: participants, outcome assessors, investigators, site staff, laboratory personnel, Sponsor study staff. - No blinding for site staff who prepare and administer the study interventions. - Specific Sponsor personnel will be unblinded for the assessment of safety in the sentinel cohort.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Group 1: RSV + HMPV Vaccine-Dose 1 		Participants will receive RSV + HMPV vaccine corresponding to Dose 1 with a predefined antigen ratio
  • Biological: RSV+HMPV vaccine
    RSV + HMPV Candidate Vaccine
Experimental
Group 2: RSV + HMPV Vaccine-Dose 2 		Participants will receive RSV + HMPV vaccine corresponding to Dose 2 with a predefined antigen ratio
  • Biological: RSV+HMPV vaccine
    RSV + HMPV Candidate Vaccine
Experimental
Group 3: RSV + HMPV Vaccine-Dose 3 		Participants will receive RSV + HMPV vaccine corresponding to Dose 3 with a predefined antigen ratio
  • Biological: RSV+HMPV vaccine
    RSV + HMPV Candidate Vaccine
Experimental
Group 4: RSV + HMPV Vaccine-Dose 4 		Participants will receive RSV + HMPV vaccine corresponding to Dose 4 with a predefined antigen ratio
  • Biological: RSV+HMPV vaccine
    RSV + HMPV Candidate Vaccine
Experimental
Group 5: RSV + HMPV Vaccine-Dose 5 		Participants will receive RSV + HMPV vaccine corresponding to Dose 5 with a predefined antigen ratio
  • Biological: RSV+HMPV vaccine
    RSV + HMPV Candidate Vaccine
Experimental
Group 6: RSV + HMPV Vaccine-Dose 6 		Participants will receive RSV + HMPV vaccine corresponding to Dose 6 with a predefined antigen ratio
  • Biological: RSV+HMPV vaccine
    RSV + HMPV Candidate Vaccine
Active Comparator
Group 7: Control Vaccine 1 		Participants will receive control vaccine 1
  • Biological: Control Vaccine 1
    Control Vaccine 1
Placebo Comparator
Group 8: Placebo 		Participants will receive Placebo
  • Other: Placebo
    Placebo
Other
Group 9: Control Vaccine 2 		Participants will receive control vaccine 2 at a predefined dose and antigen ratio
  • Biological: Control Vaccine 2
    Control Vaccine 2
Other
Group 10: Control Vaccine 3 		Participants will receive control vaccine 3 at a predefined dose
  • Biological: Control Vaccine 3
    Control Vaccine 3
Other
Group 11: Control Vaccine 4 		Participants will receive control vaccine 4 at a predefined dose
  • Biological: Control Vaccine 4
    Control Vaccine 4

Recruiting Locations

Hawthorne Health - Gadsden City Pharmacy- Site Number : 8400025
Gadsden, Alabama 35901

Scottsdale Clinical Trials- Site Number : 8400011
Scottsdale, Arizona 85260

Long Beach Research Institute- Site Number : 8400005
Long Beach, California 90805

Alliance Clinical - San Diego- Site Number : 8400033
San Diego, California 92120

Accel Research Sites Network - DeLand Clinical Research Unit- Site Number : 8400064
DeLand, Florida 32720

Accel Research Sites - NeuroStudies- Site Number : 8400063
Decatur, Georgia 30030

DM Clinical Research - Chicago- Site Number : 8400050
Melrose Park, Illinois 60160

DM Clinical Research - Detroit- Site Number : 8400049
Southfield, Michigan 48076

Velocity Clinical Research - Lincoln - Valley Road- Site Number : 8400016
Lincoln, Nebraska 68510

Alliance Clinical - Las Vegas- Site Number : 8400034
Las Vegas, Nevada 89109

Hawthorne Health - Staten Island- Site Number : 8400026
Staten Island, New York 10309

DM Clinical Research - Philadelphia- Site Number : 8400046
Philadelphia, Pennsylvania 19107

Coastal Carolina Research Center - North Charleston- Site Number : 8400061
North Charleston, South Carolina 29405

Velocity Clinical Research - Austin- Site Number : 8400013
Austin, Texas 78759

DM Clinical Research - Sugar Land- Site Number : 8400048
Sugar Land, Texas 77478

DM Clinical Research - Tomball- Site Number : 8400045
Tomball, Texas 77375

Charlottesville Medical Research- Site Number : 8400062
Charlottesville, Virginia 22911

More Details

Status
Recruiting
Sponsor
Sanofi

Study Contact

Trial Transparency email recommended (Toll free for US & Canada)
800-633-1610
Contact-US@sanofi.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.