[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655769":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":11,"studyPopulation":11,"armGroups":46,"interventions":62,"overallOfficials":72,"centralContacts":76,"locations":81,"responsibleParty":236,"collaborators":11,"id":238,"slug":239,"hasResults":240,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":11,"eligibilityCriteria":244,"healthyVolunteers":245,"sex":246,"minAge":247,"maxAge":11,"enrollmentInfo":248,"targetDuration":11,"studyType":251,"phases":252,"briefSummary":254,"conditions":255,"keywords":258,"overallStatus":225,"whyStopped":11,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":265,"completionDateStruct":267,"leadSponsor":269,"locationsCount":270},{"fullName":5,"class":6},"Pfizer","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":29,"otherOutcomes":11},[9,13,15,18,21,23,26],{"measure":10,"description":11,"timeFrame":12},"Percentage of participants reporting local reactions: pain at the injection site, redness, and swelling",null,"Within 7 days after vaccination",{"measure":14,"description":11,"timeFrame":12},"Percentage of participants reporting systemic events: fever, fatigue, headache, vomiting, nausea, diarrhea, muscle pain, and joint pain",{"measure":16,"description":11,"timeFrame":17},"Percentage of participants reporting adverse events (AEs)","Within 1 month after vaccination",{"measure":19,"description":11,"timeFrame":20},"Percentage of participants reporting serious adverse events (SAEs)","Through 6 months after vaccination",{"measure":22,"description":11,"timeFrame":20},"Percentage of participants reporting newly diagnosed chronic medical conditions (NDCMCs)",{"measure":24,"description":11,"timeFrame":25},"RSV A and RSV B neutralizing antibody levels before vaccination and 1 month after vaccination","Before vaccination and 1 month after vaccination",{"measure":27,"description":11,"timeFrame":28},"Geometric mean fold rise in RSV A and RSV B neutralizing antibody levels from before vaccination to 1 month after vaccination","Before vaccination to 1 month after vaccination",[30],{"measure":31,"description":11,"timeFrame":32},"Seroresponse rate for RSV A and RSV B neutralizing antibody levels","1 month after vaccination",{"allocation":34,"interventionModel":35,"interventionModelDescription":36,"primaryPurpose":37,"observationalModel":11,"timePerspective":11,"maskingInfo":38},"RANDOMIZED","PARALLEL","Phase 3, interventional, parallel assignment","PREVENTION",{"masking":39,"maskingDescription":40,"whoMasked":41},"QUADRUPLE","The China cohort will receive the study interventions double-blinded and will be randomized in a ratio of 2:1 to receive either RSVpreF or placebo.\n\nThe US cohort will receive the study intervention open-label in a single-arm design and will receive RSVpreF.",[42,43,44,45],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[47,53,59],{"label":48,"type":49,"description":50,"interventionNames":51},"China Placebo","PLACEBO_COMPARATOR","Single dose, Placebo vaccine",[52],"Other: Placebo",{"label":54,"type":55,"description":56,"interventionNames":57},"China RSVpreF","ACTIVE_COMPARATOR","Single dose, RSVpreF vaccine",[58],"Biological: RSVpreF",{"label":60,"type":55,"description":56,"interventionNames":61},"US RSVpreF",[58],[63,68],{"type":64,"name":65,"description":66,"armGroupLabels":67,"otherNames":11},"BIOLOGICAL","RSVpreF","Single Dose",[54,60],{"type":69,"name":70,"description":66,"armGroupLabels":71,"otherNames":11},"OTHER","Placebo",[48],[73],{"name":74,"affiliation":5,"role":75},"Pfizer CT.gov Call Center","STUDY_DIRECTOR",[77],{"name":74,"role":78,"phone":79,"phoneExt":11,"email":80},"CONTACT","1-800-718-1021","ClinicalTrials.gov_Inquiries@pfizer.com",[82,96,106,115,125,135,145,155,165,175,185,195,204,214,223],{"facility":83,"status":84,"city":85,"state":86,"zip":87,"country":88,"countryCode":89,"cosmosGeoPoint":90,"geoPoint":95,"contacts":11},"Headlands Research - Scottsdale","NOT_YET_RECRUITING","Scottsdale","Arizona","85260","United States","US",{"type":91,"coordinates":92},"Point",[93,94],-111.89903,33.50921,{"lat":94,"lon":93},{"facility":97,"status":84,"city":98,"state":99,"zip":100,"country":88,"countryCode":89,"cosmosGeoPoint":101,"geoPoint":105,"contacts":11},"Orange County Research Center","Lake Forest","California","92630",{"type":91,"coordinates":102},[103,104],-117.68922,33.64697,{"lat":104,"lon":103},{"facility":107,"status":84,"city":108,"state":99,"zip":109,"country":88,"countryCode":89,"cosmosGeoPoint":110,"geoPoint":114,"contacts":11},"Artemis Institute for Clinical Research","Riverside","92503",{"type":91,"coordinates":111},[112,113],-117.39616,33.95335,{"lat":113,"lon":112},{"facility":116,"status":84,"city":117,"state":118,"zip":119,"country":88,"countryCode":89,"cosmosGeoPoint":120,"geoPoint":124,"contacts":11},"Clinical Research Consulting, LLC","Milford","Connecticut","06460",{"type":91,"coordinates":121},[122,123],-73.0565,41.22232,{"lat":123,"lon":122},{"facility":126,"status":84,"city":127,"state":128,"zip":129,"country":88,"countryCode":89,"cosmosGeoPoint":130,"geoPoint":134,"contacts":11},"George Washington University","Washington D.C.","District of Columbia","20037",{"type":91,"coordinates":131},[132,133],-77.03637,38.89511,{"lat":133,"lon":132},{"facility":136,"status":84,"city":137,"state":138,"zip":139,"country":88,"countryCode":89,"cosmosGeoPoint":140,"geoPoint":144,"contacts":11},"Solaris Clinical Research","Meridian","Idaho","83646",{"type":91,"coordinates":141},[142,143],-116.39151,43.61211,{"lat":143,"lon":142},{"facility":146,"status":84,"city":147,"state":148,"zip":149,"country":88,"countryCode":89,"cosmosGeoPoint":150,"geoPoint":154,"contacts":11},"MediSphere Medical Research Center, LLC","Evansville","Indiana","47714",{"type":91,"coordinates":151},[152,153],-87.55585,37.97476,{"lat":153,"lon":152},{"facility":156,"status":84,"city":157,"state":158,"zip":159,"country":88,"countryCode":89,"cosmosGeoPoint":160,"geoPoint":164,"contacts":11},"IMA Clinical Research Warren","Warren Township","New Jersey","07059",{"type":91,"coordinates":161},[162,163],-74.51803,40.60822,{"lat":163,"lon":162},{"facility":166,"status":84,"city":167,"state":168,"zip":169,"country":88,"countryCode":89,"cosmosGeoPoint":170,"geoPoint":174,"contacts":11},"Remington-Davis, Inc","Columbus","Ohio","43215",{"type":91,"coordinates":171},[172,173],-82.99879,39.96118,{"lat":173,"lon":172},{"facility":176,"status":84,"city":177,"state":178,"zip":179,"country":88,"countryCode":89,"cosmosGeoPoint":180,"geoPoint":184,"contacts":11},"DM Clinical Research - Philadelphia","Philadelphia","Pennsylvania","19107",{"type":91,"coordinates":181},[182,183],-75.16362,39.95238,{"lat":183,"lon":182},{"facility":186,"status":84,"city":187,"state":188,"zip":189,"country":88,"countryCode":89,"cosmosGeoPoint":190,"geoPoint":194,"contacts":11},"J. Lewis Research, Inc. \u002F Foothill Family Clinic Draper","Draper","Utah","84020",{"type":91,"coordinates":191},[192,193],-111.86382,40.52467,{"lat":193,"lon":192},{"facility":196,"status":84,"city":197,"state":188,"zip":198,"country":88,"countryCode":89,"cosmosGeoPoint":199,"geoPoint":203,"contacts":11},"J. Lewis Research, Inc. \u002F Jordan River Family Medicine","South Jordan","84095",{"type":91,"coordinates":200},[201,202],-111.92966,40.56217,{"lat":202,"lon":201},{"facility":205,"status":84,"city":206,"state":207,"zip":208,"country":88,"countryCode":89,"cosmosGeoPoint":209,"geoPoint":213,"contacts":11},"Charlottesville Medical Research Center, LLC","Charlottesville","Virginia","22911",{"type":91,"coordinates":210},[211,212],-78.47668,38.02931,{"lat":212,"lon":211},{"facility":215,"status":84,"city":216,"state":207,"zip":217,"country":88,"countryCode":89,"cosmosGeoPoint":218,"geoPoint":222,"contacts":11},"Clinical Research Partners, LLC","Richmond","23226",{"type":91,"coordinates":219},[220,221],-77.46026,37.55376,{"lat":221,"lon":220},{"facility":224,"status":225,"city":226,"state":227,"zip":228,"country":229,"countryCode":230,"cosmosGeoPoint":231,"geoPoint":235,"contacts":11},"Huashan Hospital Fudan University","RECRUITING","Shanghai","Shanghai Municipality","200040","China","CN",{"type":91,"coordinates":232},[233,234],121.45806,31.22222,{"lat":234,"lon":233},{"type":237,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100655769","phase-3-a-study-to-learn-about-the-safety-and-immune-responses-of-rsvpref-in-older-adults-100655769",false,"NCT07819097","A Study to Learn About the Safety and Immune Responses of RSVpreF in Older Adults","AN INTERVENTIONAL PHASE 3 STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN PARTICIPANTS 60 YEARS OF AGE AND OLDER","Key Inclusion Criteria\n\n* Participants 60 years of age or older at enrolment.\n* Healthy participants, or participants with stable long-term medical conditions, if the investigator decides they can take part.\n* Adults who can walk and live in the community or in assisted-living\u002Flong-term care settings with minimal help.\n* Participants who can give signed informed consent and follow study visits and procedures, including the 7-day electronic diary and blood tests.\n\nKey Exclusion Criteria\n\n* Confirmed RSV infection 180 days or less before study vaccination.\n* Any past history of Guillain-Barré syndrome.\n* Severe reaction to a vaccine or severe allergy to a study vaccine component or related vaccine.\n* Serious or unstable medical condition that the investigator believes makes the study unsafe.\n* Immunocompromised status, based on medical history and\u002For examination.\n* Previous receipt of any licensed or investigational RSV vaccine or RSV preventive monoclonal antibody, or planned receipt during the study.\n\nPlease refer to the study contact for further eligibility details Contacts\u002FLocations Central Contact Person: Pfizer CT.gov Call Center Telephone: 1-800-718-1021 Email: ClinicalTrials.gov\\_Inquiries@pfizer.com",true,"ALL","60 Years",{"count":249,"type":250},600,"ESTIMATED","INTERVENTIONAL",[253],"PHASE3","The purpose of this study is to learn about the safety, tolerability, and immune response of the RSVpreF vaccine in healthy older adults.\n\nParticipants will take part in this study for about 6 months.\n\nThe study will include people in China and the United States. In China, participants will receive either RSVpreF or placebo. A placebo is a dummy vaccine with no active ingredient, but it looks just like the vaccine being studied. In the United States, all participants will receive RSVpreF.\n\nResearchers will check for any reactions. They will also check blood test results to learn how the body responds to the vaccine.\n\nThe main questions the study aims to answer are:\n\n* What local reactions and systemic events (body-wide symptoms) do participants have after a RSVpreF vaccination?\n* What medical problems do participants have after a RSVpreF vaccination?\n* Researchers will compare antibody levels from blood tests between the China cohort and the US cohort. An antibody is a substance in the body that try to fight off an infection or foreign substance.\n\nParticipants will:\n\n* Have a screening visit to make sure they qualify for the study (participants in China will have this visit before the day of vaccination)\n* Receive the RSVpreF vaccination (or a placebo injection if in the China cohort) once at Visit 1.\n* Have a telephone or clinic visit 1 week later to assess local reactions and systemic events.\n* Have a clinic visit a month after vaccination for a checkup and tests.\n* Have a telephone or clinic visit 6 months after vaccination for a health check.\n* Have a blood test at screening (if in the China cohort only), on the day of vaccination and 1 month after vaccination.",[256,257],"Adult","Healthy Participants",[259,260],"RSV vaccine","Respiratory Syncytial Virus (RSV)","2026-10-08",{"date":263,"type":264},"2026-10-09","ACTUAL",{"date":266,"type":264},"2026-09-09",{"date":268,"type":250},"2027-05-16",{"name":5,"class":6},15]