[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07734649":3,"trial-entities:NCT07734649":292,"trial-summary:NCT07734649":297},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":30,"interventions":33,"primary_outcomes":66,"secondary_outcomes":102,"sex":125,"minimum_age":126,"maximum_age":17,"healthy_volunteers":127,"eligibility_criteria":128,"std_ages":144,"locations":147,"central_contacts":282,"overall_officials":289,"references":290,"see_also_links":291},"NCT07734649","VCA23395","Phase 1\u002F2 Study of Respiratory Syncytial Virus and Human Metapneumovirus (RSV+HMPV) Vaccine Candidate in Adults 60 Years of Age and Older","A Phase 1\u002F2, Randomized, Controlled, Observer-Blind Study in Adults 60 Years of Age and Older to Evaluate the Immunogenicity and Safety of Different Dose Levels of a Bivalent Vaccine Candidate Against Respiratory Syncytial Virus (RSV) and Human Metapneumovirus (HMPV)","RECRUITING","2028-05-03","2026-07","2026-07-29","2026-07-22","Sanofi","INDUSTRY",false,"This study is a Phase 1\u002F2, 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\u002Flicensed 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.\n\nThe study will consist of 4 cohorts and 11 vaccine groups (RSV+HMPV \\[6 dose levels\\], placebo and 4 control groups).\n\nThe duration of the study will be approximately 12 months for each participant.",null,[19,20,21],"Respiratory Syncytial Virus Immunization","Human Metapneumovirus Immunization","Healthy Volunteers",[23,24],"RSV","HMPV","INTERVENTIONAL","PREVENTION",[28,29],"PHASE1","PHASE2",{"count":31,"type":32},2400,"ESTIMATED",[34,45,49,53,57,62],{"type":35,"name":36,"description":37,"armGroupLabels":38},"BIOLOGICAL","RSV+HMPV vaccine","RSV + HMPV Candidate Vaccine",[39,40,41,42,43,44],"Group 1: RSV + HMPV Vaccine-Dose 1","Group 2: RSV + HMPV Vaccine-Dose 2","Group 3: RSV + HMPV Vaccine-Dose 3","Group 4: RSV + HMPV Vaccine-Dose 4","Group 5: RSV + HMPV Vaccine-Dose 5","Group 6: RSV + HMPV Vaccine-Dose 6",{"type":35,"name":46,"description":46,"armGroupLabels":47},"Control Vaccine 3",[48],"Group 10: Control Vaccine 3",{"type":35,"name":50,"description":50,"armGroupLabels":51},"Control Vaccine 4",[52],"Group 11: Control Vaccine 4",{"type":35,"name":54,"description":54,"armGroupLabels":55},"Control Vaccine 2",[56],"Group 9: Control Vaccine 2",{"type":58,"name":59,"description":59,"armGroupLabels":60},"OTHER","Placebo",[61],"Group 8: Placebo",{"type":35,"name":63,"description":63,"armGroupLabels":64},"Control Vaccine 1",[65],"Group 7: Control Vaccine 1",[67,71,74,76,78,82,86,90,94,98],{"measure":68,"description":69,"timeFrame":70},"RSV A serum nAb (neutralizing antibodies) titers","nAb titers expressed as geometric mean titers (GMTs)","At Day 1 and Day 29",{"measure":72,"description":73,"timeFrame":70},"RSV B serum nAb titers","nAb titers expressed as GMTs",{"measure":75,"description":73,"timeFrame":70},"HMPV A serum nAb titers",{"measure":77,"description":73,"timeFrame":70},"HMPV B serum nAb titers",{"measure":79,"description":80,"timeFrame":81},"Unsolicited systemic Adverse Events (AEs) that occur within 30 minutes after vaccination","Number of participants reporting immediate unsolicited systemic AEs","Within 30 minutes after vaccination",{"measure":83,"description":84,"timeFrame":85},"Presence of solicited injection site and systemic reactions","Number of participants reporting:\n\n* injection site reactions: pain, erythema and swelling\n* systemic reactions: fever, headache, fatigue and myalgia","For 8 days, including the day of vaccination",{"measure":87,"description":88,"timeFrame":89},"Presence of Unsolicited AEs","Number of participants reporting unsolicited AEs","For 28 days, including day of vaccination",{"measure":91,"description":92,"timeFrame":93},"Presence of medically attended AEs (MAAEs)","Number of participants reporting MAAEs","Within 6 months after vaccination",{"measure":95,"description":96,"timeFrame":97},"Presence of Serious Adverse Events (SAEs), fatal SAEs and Adverse Events of Special Interest (AESIs)","Number of participants reporting SAEs, fatal SAEs and AESIs","Throughout the study (approximately 12 months)",{"measure":99,"description":100,"timeFrame":101},"Presence of out-of-range biological test results","Number of participants with biological safety assessment values out of normal range (including shift from baseline values)","At Day 09",[103,106,109,111,113,117,120,123],{"measure":104,"description":69,"timeFrame":105},"RSV A serum nAb titers at 3, 6, 9, and 12 months post-vaccination","3, 6, 9, and 12-months post-vaccination",{"measure":107,"description":73,"timeFrame":108},"RSV B serum nAb titers at 3, 6, 9, and 12 months post-vaccination","3, 6, 9, and 12 months post-vaccination",{"measure":110,"description":73,"timeFrame":108},"HMPV A serum nAb titers at 3, 6, 9, and 12 months post-vaccination",{"measure":112,"description":73,"timeFrame":108},"HMPV B serum nAb titers at 3, 6, 9, and 12 months post-vaccination",{"measure":114,"description":115,"timeFrame":116},"Serum RSV preF immunoglobulin G (IgG) Ab concentrations at pre-vaccination (Day 01), and at 28 days (Day 29), 3, 6, 9, and 12 months post-vaccination","Ab concentration expressed as geometric mean concentrations (GMCs)","pre-vaccination (Day 01), and at 28 days (Day 29), 3, 6, 9, and 12 months post-vaccination",{"measure":118,"description":119,"timeFrame":116},"Serum HMPV preF immunoglobulin G (IgG) Ab concentrations at pre-vaccination (Day 01), and at 28 days (Day 29), 3, 6, 9, and 12 months post-vaccination","Ab concentration expressed as GMCs",{"measure":121,"timeFrame":122},"Ratio of RSV A and RSV B serum nAb titer fold-rise over anti-preF IgG Ab concentration fold-rise at Day 29, 3, 6, 9, and 12 months post-vaccination, from pre vaccination (Day 01)","Day 29, 3, 6, 9, and 12 months post-vaccination, from pre-vaccination (Day 01)",{"measure":124,"timeFrame":122},"Ratio of HMPV A and HMPV B serum nAb titer fold-rise over anti-preF IgG Ab concentration fold-rise at Day 29, 3, 6, 9, and 12 months post-vaccination, from pre vaccination (Day 01)","ALL","60 Years",true,{"inclusion":129,"exclusion":132,"raw_text":143},[130,131],"Aged 60 years or older on the day of inclusion","Non-childbearing potential (ie, post-menopausal for at least 1 year or surgically sterile)",[133,134,135,136,137,138,139,140,141,142],"History of laboratory-confirmed RSV and\u002For laboratory-confirmed HMPV infection affecting the participant and\u002For the participant's household in the previous 12 months","Previous history of myocarditis, pericarditis, and\u002For myopericarditis","Screening electrocardiogram (ECG) that is consistent with possible myocarditis, pericarditis, and\u002For 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-Barré Syndrome","Any vaccine given 4 weeks before or 4 weeks after study intervention","Previous vaccination against RSV and\u002For HMPV with an investigational or marketed vaccine","Receipt of any mRNA vaccine\u002Fproduct 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","Inclusion Criteria:\n\n* Aged 60 years or older on the day of inclusion\n* Non-childbearing potential (ie, post-menopausal for at least 1 year or surgically sterile)\n\nExclusion Criteria:\n\n* History of laboratory-confirmed RSV and\u002For laboratory-confirmed HMPV infection affecting the participant and\u002For the participant's household in the previous 12 months\n* Previous history of myocarditis, pericarditis, and\u002For myopericarditis\n* Screening electrocardiogram (ECG) that is consistent with possible myocarditis, pericarditis, and\u002For myopericarditis or, in the opinion of the investigator, demonstrates clinically relevant abnormalities that may affect participant safety or study results\n* Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion\n* Previous history of Guillain-Barré Syndrome\n* Any vaccine given 4 weeks before or 4 weeks after study intervention\n* Previous vaccination against RSV and\u002For HMPV with an investigational or marketed vaccine\n* Receipt of any mRNA vaccine\u002Fproduct in the 2 months preceding study intervention administration\n* Has received a blood transfusion or blood-derived products, including immunoglobulins, in the past 3 months\n* Any screening laboratory parameter with laboratory abnormality \\> Grade 1 or deemed clinically significant by the investigator; if deemed appropriate, investigator may repeat these assessments\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.",[145,146],"ADULT","OLDER_ADULT",[148,157,165,173,180,188,196,204,212,220,228,236,244,252,260,267,274],{"facility":149,"status":8,"city":150,"state":151,"zip":152,"country":153,"geoPoint":154},"Hawthorne Health - Gadsden City Pharmacy- Site Number : 8400025","Gadsden","Alabama","35901","United States",{"lat":155,"lon":156},34.01434,-86.00639,{"facility":158,"status":8,"city":159,"state":160,"zip":161,"country":153,"geoPoint":162},"Scottsdale Clinical Trials- Site Number : 8400011","Scottsdale","Arizona","85260",{"lat":163,"lon":164},33.50921,-111.89903,{"facility":166,"status":8,"city":167,"state":168,"zip":169,"country":153,"geoPoint":170},"Long Beach Research Institute- Site Number : 8400005","Long Beach","California","90805",{"lat":171,"lon":172},33.76696,-118.18923,{"facility":174,"status":8,"city":175,"state":168,"zip":176,"country":153,"geoPoint":177},"Alliance Clinical - San Diego- Site Number : 8400033","San Diego","92120",{"lat":178,"lon":179},32.71571,-117.16472,{"facility":181,"status":8,"city":182,"state":183,"zip":184,"country":153,"geoPoint":185},"Accel Research Sites Network - DeLand Clinical Research Unit- Site Number : 8400064","DeLand","Florida","32720",{"lat":186,"lon":187},29.02832,-81.30312,{"facility":189,"status":8,"city":190,"state":191,"zip":192,"country":153,"geoPoint":193},"Accel Research Sites - NeuroStudies- Site Number : 8400063","Decatur","Georgia","30030",{"lat":194,"lon":195},33.77483,-84.29631,{"facility":197,"status":8,"city":198,"state":199,"zip":200,"country":153,"geoPoint":201},"DM Clinical Research - Chicago- Site Number : 8400050","Melrose Park","Illinois","60160",{"lat":202,"lon":203},41.90059,-87.85673,{"facility":205,"status":8,"city":206,"state":207,"zip":208,"country":153,"geoPoint":209},"DM Clinical Research - Detroit- Site Number : 8400049","Southfield","Michigan","48076",{"lat":210,"lon":211},42.47337,-83.22187,{"facility":213,"status":8,"city":214,"state":215,"zip":216,"country":153,"geoPoint":217},"Velocity Clinical Research - Lincoln - Valley Road- Site Number : 8400016","Lincoln","Nebraska","68510",{"lat":218,"lon":219},40.8,-96.66696,{"facility":221,"status":8,"city":222,"state":223,"zip":224,"country":153,"geoPoint":225},"Alliance Clinical - Las Vegas- Site Number : 8400034","Las Vegas","Nevada","89109",{"lat":226,"lon":227},36.17497,-115.13722,{"facility":229,"status":8,"city":230,"state":231,"zip":232,"country":153,"geoPoint":233},"Hawthorne Health - Staten Island- Site Number : 8400026","Staten Island","New York","10309",{"lat":234,"lon":235},40.56233,-74.13986,{"facility":237,"status":8,"city":238,"state":239,"zip":240,"country":153,"geoPoint":241},"DM Clinical Research - Philadelphia- Site Number : 8400046","Philadelphia","Pennsylvania","19107",{"lat":242,"lon":243},39.95238,-75.16362,{"facility":245,"status":8,"city":246,"state":247,"zip":248,"country":153,"geoPoint":249},"Coastal Carolina Research Center - North Charleston- Site Number : 8400061","North Charleston","South Carolina","29405",{"lat":250,"lon":251},32.85462,-79.97481,{"facility":253,"status":8,"city":254,"state":255,"zip":256,"country":153,"geoPoint":257},"Velocity Clinical Research - Austin- Site Number : 8400013","Austin","Texas","78759",{"lat":258,"lon":259},30.26715,-97.74306,{"facility":261,"status":8,"city":262,"state":255,"zip":263,"country":153,"geoPoint":264},"DM Clinical Research - Sugar Land- Site Number : 8400048","Sugar Land","77478",{"lat":265,"lon":266},29.61968,-95.63495,{"facility":268,"status":8,"city":269,"state":255,"zip":270,"country":153,"geoPoint":271},"DM Clinical Research - Tomball- Site Number : 8400045","Tomball","77375",{"lat":272,"lon":273},30.09716,-95.61605,{"facility":275,"status":8,"city":276,"state":277,"zip":278,"country":153,"geoPoint":279},"Charlottesville Medical Research- Site Number : 8400062","Charlottesville","Virginia","22911",{"lat":280,"lon":281},38.02931,-78.47668,[283],{"name":284,"role":285,"phone":286,"phoneExt":287,"email":288},"Trial Transparency email recommended (Toll free for US & Canada)","CONTACT","800-633-1610","option 6","Contact-US@sanofi.com",[],[],[],{"nct_id":4,"conditions":293,"biomarkers":296},[294,295],"Human Metapneumovirus Infection","Respiratory Syncytial Virus Infection",[],{"nct_id":4,"found":127,"summary":298,"prompt_version":308},{"design":299,"status":300,"heading":301,"summary":302,"follow_up":303,"word_count":304,"commitments":305,"compensation":306,"drugs_mentioned":307},"This is a Phase 1\u002F2, randomized, observer-blind, active and placebo-controlled study involving about 2400 adults aged 60 and older.","completed","Phase 1\u002F2 Study of RSV+HMPV Vaccine in Adults 60 and Older","This study is testing a new vaccine called RSV+HMPV to see if it can safely prevent infections from Respiratory Syncytial Virus (RSV) and Human Metapneumovirus (HMPV) in adults aged 60 and older. While there are already vaccines for RSV, there isn't one yet for HMPV in older adults. Researchers want to understand how well the RSV+HMPV vaccine works by measuring your body's immune response (neutralizing antibodies) to RSV and HMPV at the beginning of the study and again on Day 29. You might receive the RSV+HMPV vaccine at different dose levels, a placebo (an inactive substance), or one of four other control vaccines. This study aims to gather important information to help develop this vaccine further.","Your immune response will be measured on Day 1 and Day 29 after receiving the vaccine.",116,"Not specified in the trial record.","Not stated in the trial record.",[36,59],"v2"]