Study of a Human Metapneumovirus/Respiratory Syncytial Virus mRNA Vaccine Candidate Encapsulated in a Lipid Nanoparticle-based Formulation in Adults Aged 60 Years and Older
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi Pasteur, a Sanofi Company
Age
60–any
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year or surgically sterile
You may not be if
Any screening laboratory parameter with laboratory abnormality \> Grade 1 deemed clinically significant by the investigator
Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months). Of note, 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 an mRNA vaccine
History of RSV and/or hMPV-associated illness, diagnosed 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
Laboratory-confirmed thrombocytopenia, contraindicating IM injection, based on investigator's judgment
Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM injection, based on investigator's judgment
Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
Receipt of any vaccine other than mRNA vaccine in the 28 days preceding any study intervention administration or planned receipt of any vaccine other than mRNA vaccine in the 28 days 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
Note: The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Clareo Health | Study of a Human Metapneumovirus/Respiratory Syncytial Virus mRNA Vaccine Candidate Encapsulated in a Lipid Nanoparticle-based Formulation in Adults Aged 60 Years and Older
