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0360007","Canberra","2617",{"type":66,"coordinates":224},[225,226],149.12807,-35.28346,{"lat":226,"lon":225},{"type":229,"investigatorFullName":47,"investigatorTitle":47,"investigatorAffiliation":47,"oldNameTitle":47,"oldOrganization":47},"SPONSOR","100534320","phase-1-study-of-the-safety-and-immune-response-of-an-investigational-mrna-vaccine-for-the-prevention-of-respiratory-syncytial-virus-andor-human-metapneumovirus-in-participants-aged-18-to-49-years-and-60-years-and-older-100534320",false,"NCT06237296","Study of the Safety and Immune Response of an Investigational mRNA Vaccine for the Prevention of Respiratory Syncytial Virus and\u002For Human Metapneumovirus in Participants Aged 18 to 49 Years and 60 Years and Older","A Phase I, Dose-escalation, Parallel-group, Randomized, Multi-center Study to Assess Safety and Immunogenicity of an RSV\u002FhMPV mRNA Vaccine Candidate in Healthy Participants Aged 18 to 49 Years and 60 Years and Older.","Inclusion Criteria:\n\n-Informed consent form (ICF) has been signed and dated\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n-Any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.\n\n--The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.",true,"ALL","18 Years",{"count":241,"type":242},558,"ACTUAL","INTERVENTIONAL",[245],"PHASE1","The purpose of this study is to evaluate the safety and immunogenicity an investigational messenger ribonucleic acid (mRN)A vaccine for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) and\u002For human metapneumovirus (hMPV) in older adults. A single intramuscular (IM) injection of 3 to 4 different doses of the RSV\u002FhMPV mRNA vaccine candidate formulated with 2 different lipid nanoparticles (LNP) will be administered to healthy participants aged 18 to 49 years and 60 years and older.\n\nTreatment:\n\n* RSV\u002FhMPV mRNA \u002F LNP 1 at 3-4 different doses or,\n* RSV\u002FhMPV mRNA \u002F LNP 2 at 3-4 difference doses or,\n* RSV mRNA \u002F LNP 1 at 1 dose or,\n* hMPV mRNA \u002F LNP 1 at 1 dose",[248,249,250],"Respiratory Syncytial Virus Infection","Healthy Volunteers","Metapneumovirus Infection","COMPLETED","2025-09-04",{"date":254,"type":242},"2025-09-11",{"date":256,"type":242},"2024-01-23",{"date":258,"type":242},"2025-02-11",{"name":260,"class":6},"Sanofi Pasteur, a Sanofi Company",17]