Status:
ACTIVE_NOT_RECRUITING
Study of a Respiratory Syncytial Virus/Human Metapneumovirus Vaccine Candidate
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Respiratory Syncytial Virus Infection
Healthy Volunteers
Eligibility:
All Genders
60+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to assess the safety and immunogenicity of a single intramuscular (IM) injection of different doses of an respiratory syncytial virus (RSV) and human metapneumovirus (hMPV...
Detailed Description
Study duration per participant: 12 months for the Sentinel and Main Cohorts and 24 months overall for the subset of participants enrolled in the Booster Cohort. Treatment Duration: Sentinel Cohort:...
Eligibility Criteria
Inclusion
- Aged 60 years or older on the day of inclusion
- A female participant is eligible to participate if she is not pregnant or breastfeeding and is of non-childbearing potential.
- Participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion Note: Participants with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included.
Exclusion
- Participants are excluded from the study if any of the following criteria apply:
- Any screening laboratory parameter with laboratory abnormalities deemed clinically significant by the investigator
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy. Persons living with stable human immunodeficiency virus (HIV) are not excluded
- Known systemic hypersensitivity to any of the study intervention components (eg, polyethylene glycol, polysorbate); history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances; any allergic reaction (eg, anaphylaxis) after administration of mRNA coronavirus disease 2019 (COVID-19) vaccine
- History of RSV and/or hMPV-associated illness, diagnosed clinically, serologically, or microbiologically in the last 12 months
- Previous history of myocarditis, pericarditis, and/or myopericarditis
- Screening electrocardiogram 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
- Thrombocytopenia or bleeding disorder, contraindicating intramuscular (IM) injection based on investigator's judgment
- Receipt of anticoagulants in the 3 weeks preceding inclusion
- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
- Alcohol, prescription drug, or substance abuse that, in the opinion of the investigator, might interfere with the study conduct or completion
- History of acute infection symptoms or a positive severe acute respiratory syndrome coronavirus reverse transcription polymerase chain reaction (SARS-CoV-2 RT-PCR) or antigen test in the 10 days prior to the visit. A prospective participant should not be included in the study until the condition has resolved
- Receipt of any vaccine other than mRNA vaccine in the 4 weeks preceding any study intervention administration or planned receipt of any vaccine other than mRNA vaccine in the 4 weeks following any study intervention administration
- Receipt of any mRNA vaccine in the 60 days preceding any study intervention administration or planned receipt of any mRNA vaccine in the 60 days following any study intervention administration
- Previous vaccination against RSV and/or hMPV (with a licensed or investigational vaccine either as a monovalent vaccine or any combination of the antigens)
- Receipt of immune globulins, blood, or blood-derived products in the past 3 months
- Participation at the time of study enrollment (or in the 4 weeks preceding the first study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 10 2026
Estimated Enrollment :
646 Patients enrolled
Trial Details
Trial ID
NCT06134648
Start Date
November 1 2023
End Date
March 10 2026
Last Update
August 14 2024
Active Locations (13)
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1
Collaborative Neuroscience Research Site Number : 8400017
Los Alamitos, California, United States, 90720
2
Matrix Clinical Research Site Number : 8400011
Los Angeles, California, United States, 90057
3
Peninsula Research Associates Site Number : 8400001
Rolling Hills Estates, California, United States, 90274
4
Suncoast Research Associates, LLC Site Number : 8400002
Miami, Florida, United States, 33173