[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657461":3},{"organization":4,"outcomesModule":7,"designInfo":72,"detailedDescription":82,"studyPopulation":71,"armGroups":83,"interventions":104,"overallOfficials":113,"centralContacts":117,"locations":122,"responsibleParty":143,"collaborators":71,"id":145,"slug":146,"hasResults":147,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":71,"eligibilityCriteria":151,"healthyVolunteers":152,"sex":153,"minAge":154,"maxAge":155,"enrollmentInfo":156,"targetDuration":71,"studyType":159,"phases":160,"briefSummary":162,"conditions":163,"keywords":165,"overallStatus":168,"whyStopped":71,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":178},{"fullName":5,"class":6},"Pfizer","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":60,"otherOutcomes":71},[9,13,16,19,22,26,30,34,38,41,44,48,51,55,58],{"measure":10,"description":11,"timeFrame":12},"Cohort 1: Proportion of participants reporting pre-specified local reactions within 7 days following investigational product administration","Describe pre-specified local reactions in children 5 to \\\u003C18 years of age with chronic medical conditions","Within 7 days",{"measure":14,"description":15,"timeFrame":12},"Cohort 2: Proportion of participants reporting pre-specified local reactions within 7 days following each investigational product administration","Describe pre-specified local reactions in children 5 to \\\u003C18 years of age with immunocompromising conditions",{"measure":17,"description":18,"timeFrame":12},"Cohort 1: Proportion of participants reporting pre-specified systemic events within 7 days following investigational product administration","Describe pre-specified systemic events in children 5 to \\\u003C18 years of age with chronic medical conditions",{"measure":20,"description":21,"timeFrame":12},"Cohort 2: Proportion of participants reporting pre-specified systemic events within 7 days following each investigational product administration","Describe pre-specified systemic events in children 5 to \\\u003C18 years of age with immunocompromising conditions",{"measure":23,"description":24,"timeFrame":25},"Cohort 1: Proportion of participants reporting adverse events (AEs) through 1 month following investigational product administration","Describe AEs in children 5 to \\\u003C18 years of age with chronic medical conditions","From vaccination through 1 month after vaccination",{"measure":27,"description":28,"timeFrame":29},"Cohort 2: Proportion of participants reporting adverse events (AEs) through 1 month following last investigational product administration","Describe AEs in children 5 to \\\u003C18 years of age with immunocompromising conditions","From vaccination through 1 month after last vaccination",{"measure":31,"description":32,"timeFrame":33},"Cohort 1: Proportion of participants reporting serious adverse events (SAEs) throughout the study","Describe SAEs in children 5 to \\\u003C18 years of age with chronic medical conditions","From vaccination through 24 months after vaccination",{"measure":35,"description":36,"timeFrame":37},"Cohort 2: Proportion of participants reporting serious adverse events (SAEs) throughout the study","Describe SAEs in children 5 to \\\u003C18 years of age with immunocompromising conditions","From vaccination through 12 months after last vaccination",{"measure":39,"description":40,"timeFrame":33},"Cohort 1: Proportion of participants reporting newly diagnosed chronic medical conditions (NDCMCs) throughout the study","Describe NDCMCs in children 5 to \\\u003C18 years of age with chronic medical conditions",{"measure":42,"description":43,"timeFrame":37},"Cohort 2: Proportion of participants reporting newly diagnosed chronic medical conditions (NDCMCs) throughout the study","Describe NDCMCs in children 5 to \\\u003C18 years of age with immunocompromising conditions",{"measure":45,"description":46,"timeFrame":47},"Cohort 1: Geometric mean ratio (GMR), estimated by the ratio of the geometric mean titers (GMTs) for RSV A and RSV B serum neutralizing titers (NTs) 1 month after vaccination in participants in Study C3671017 Cohort 1 compared to those in Study C3671013","Demonstrate that the immune responses elicited by RSVpreF in children 5 to \\\u003C18 years of age with chronic medical conditions are noninferior to the immune responses in adults ≥60 years of age","1 month after vaccination",{"measure":49,"description":50,"timeFrame":47},"Cohort 1: Seroresponse rate of RSV A and RSV B serum NTs at 1 month after vaccination","Demonstrate that the immune responses elicited by RSVpreF in children 5 to \\\u003C18 years of age with chronic medical conditions are noninferior to the immune responses in adults ≥60 years of age.\n\nSeroresponse is defined as a postvaccination NT ≥4 times the lower limit of quantitation (LLOQ) if the prevaccination titer is below the LLOQ; or a ≥4-fold rise from prevaccination if the prevaccination titer is ≥ LLOQ",{"measure":52,"description":53,"timeFrame":54},"Cohort 2: Neutralizing Titers (NTs) for RSV A and RSV B expressed as Geometric Mean Titers (GMT)","Describe the immune responses elicited by 1 or 2 doses of RSVpreF in children 5 to \\\u003C18 years of age with immunocompromising conditions","Before each vaccination, 1 month after each vaccination, 12 months after last vaccination",{"measure":56,"description":53,"timeFrame":57},"Cohort 2: NTs for RSV A and RSV B expressed as Geometric Mean Fold Rise (GMFR)","1 month after each vaccination, 12 months after last vaccination",{"measure":59,"description":53,"timeFrame":57},"Cohort 2: NTs for RSV A and RSV B expressed as seroresponse rate",[61,65,68],{"measure":62,"description":63,"timeFrame":64},"Cohort 1: NTs for RSV A and RSV B expressed as Geometric Mean Titers (GMT)","Describe the immune responses elicited by RSVpreF in children 5 to \\\u003C18 years of age with chronic medical conditions","Before vaccination, 1 month after vaccination, 12 months after vaccination, 24 months after vaccination",{"measure":66,"description":63,"timeFrame":67},"Cohort 1: NTs for RSV A and RSV B expressed as GMFR","1 month after vaccination, 12 months after vaccination, 24 months after vaccination",{"measure":69,"description":70,"timeFrame":67},"Cohort 1: NTs for RSV A and RSV B expressed as seroresponse rate","Describe the immune responses elicited by RSVpreF in children 5 to \\\u003C18 years of age with chronic medical conditions.\n\nSeroresponse is defined as a postvaccination NT ≥4 times the lower limit of quantitation (LLOQ) if the prevaccination titer is below the LLOQ; or a ≥4-fold rise from prevaccination if the prevaccination titer is ≥ LLOQ",null,{"allocation":73,"interventionModel":74,"interventionModelDescription":71,"primaryPurpose":75,"observationalModel":71,"timePerspective":71,"maskingInfo":76},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":77,"maskingDescription":78,"whoMasked":79},"DOUBLE","Double-blinded, placebo-controlled",[80,81],"PARTICIPANT","INVESTIGATOR","The study will first enroll immunocompetent, RSV-experienced participants before enrolling immunocompromised participants to allow for safety data review. Both Cohorts 1 (chronic conditions) and 2 (immunocompromising conditions) will be stratified into 2 age strata. Cohort 1a will enroll participants 12 to \\\u003C18 years of age with chronic medical conditions and Cohort 1b will enroll participants 5 to \\\u003C12 years of age with chronic medical conditions. Cohort 2a will enroll immunocompromised participants 12 to \\\u003C18 years of age and Cohort 2b will enroll immunocompromised participants 5 to \\\u003C12 years of age.",[84,90,96,100],{"label":85,"type":86,"description":87,"interventionNames":88},"Cohort 1: RSVpreF","EXPERIMENTAL","Cohort 1 (a and b): Participants will receive a single dose of RSVpreF at the first study visit.",[89],"Biological: RSVpreF",{"label":91,"type":92,"description":93,"interventionNames":94},"Cohort 1: Placebo","PLACEBO_COMPARATOR","Cohort 1 (a and b): Participants will receive a single dose of placebo at the first study visit.",[95],"Biological: Placebo",{"label":97,"type":86,"description":98,"interventionNames":99},"Cohort 2: RSVpreF\u002FRSVpreF","Cohort 2 (a and b): Participants will receive 1 dose of RSVpreF at the first study visit, and 1 dose of RSVpreF at the 12-month visit.",[89],{"label":101,"type":86,"description":102,"interventionNames":103},"Cohort 2: RSVpreF\u002FPlacebo","Cohort 2 (a and b): Participants will receive 1 dose of RSVpreF at the first study visit, and 1 dose of placebo at the 12-month visit.",[89,95],[105,110],{"type":106,"name":107,"description":108,"armGroupLabels":109,"otherNames":71},"BIOLOGICAL","RSVpreF","RSVpreF Vaccine",[85,101,97],{"type":106,"name":111,"description":111,"armGroupLabels":112,"otherNames":71},"Placebo",[91,101],[114],{"name":115,"affiliation":5,"role":116},"Pfizer CT.gov Call Center","STUDY_DIRECTOR",[118],{"name":115,"role":119,"phone":120,"phoneExt":71,"email":121},"CONTACT","1-800-718-1021","ClinicalTrials.gov_Inquiries@pfizer.com",[123,136],{"facility":124,"status":71,"city":125,"state":126,"zip":127,"country":128,"countryCode":129,"cosmosGeoPoint":130,"geoPoint":135,"contacts":71},"Senders Pediatrics","South Euclid","Ohio","44121","United States","US",{"type":131,"coordinates":132},"Point",[133,134],-81.51846,41.52311,{"lat":134,"lon":133},{"facility":137,"status":71,"city":138,"state":139,"zip":140,"country":141,"countryCode":142,"cosmosGeoPoint":71,"geoPoint":71,"contacts":71},"Fukuwa Clinic","Chuo-ku","Tokyo","104-0031","Japan","JP",{"type":144,"investigatorFullName":71,"investigatorTitle":71,"investigatorAffiliation":71,"oldNameTitle":71,"oldOrganization":71},"SPONSOR","100657461","phase-3-study-to-learn-about-a-respiratory-syncytial-virus-vaccine-in-children-at-high-risk-of-rsv-disease-100657461",false,"NCT07839871","Study to Learn About a Respiratory Syncytial Virus Vaccine in Children at High Risk of RSV Disease","A PHASE 3 STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A RESPIRATORY SYNCYTIAL VIRUS VACCINE IN CHILDREN AT HIGH RISK OF RSV DISEASE","Key Inclusion Criteria:\n\n* Participants' age requirements for each study cohort at enrollment, respectively Cohort 1a (chronic medical conditions) 12 to \\\u003C18 years of age Cohort 1b (chronic medical conditions) 5 to \\\u003C12 years of age Cohort 2a (immunocompromising conditions) 12 to \\\u003C18 years of age Cohort 2b (immunocompromising conditions) 5 to \\\u003C12 years of age\n* Participants depending on the study cohort requirements, will be considered by the investigator to be at high risk of LRTI-RSV based on the following disease characteristics and definitions:\n\nChronic medical conditions:\n\n* Cystic fibrosis\n* Medically treated asthma\n* Other chronic respiratory diseases and malformations of the lung\n* Trisomy 21 (Down syndrome)\n* Neuromuscular disease\n* Cerebral palsy\n* Hemodynamically significant or symptomatic congenital heart disease\n* Sickle cell disease\n* Confirmed stable HIV disease defined as documented viral load \\\u003C50 copies\u002FmL and CD4 count \\>200 cells\u002Fmm3 within 6 months before enrollment, and on stable antiretroviral therapy for at least 6 months\n\nImmunocompromising conditions:\n\n* Immunomodulatory therapy: Is on an active immunosuppressive (including cytotoxic) or immunomodulatory therapy at a stable dose. Patients taking steroids as monotherapy must be on a dose of at least 2 mg\u002Fkg\u002Fday or 20 mg\u002Fday or greater OR\n* Primary immune deficiency: Has a diagnosed primary immunodeficiency disease OR\n* Cellular therapy: Has received a bone marrow or stem cell transplant at least 6 months (180 days) prior to enrollment with adequate immune reconstitution for immunization in the investigator's opinion or has received chimeric antigen receptor T cell (CAR-T) therapy more than 90 days prior to enrollment OR\n* Solid organ transplant: Has received a solid organ transplant at least 3 months prior and with no acute rejection episodes within 90 days prior to enrollment and is on ongoing immunosuppressive therapy OR\n* End-stage renal disease: Has end-stage renal disease (ESRD) on hemodialysis (HD)\n* Participants' weight must be:\n\nCohort 1a: ≥30.0 kg at enrollment Cohort 1b: ≥14.5 kg at enrollment Cohort 2a : ≥30 kg at enrollment Cohort 2b: ≥14.5 kg at enrollment\n\n•The participant's parent(s)\u002Flegal guardian is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in the protocol. Depending on the age of the participant and according to local requirements, participants will also be asked to provide assent as appropriate (verbal or written)\n\nKey Exclusion Criteria:\n\n* Applicable to Cohort 1 (a and b) participants only: Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and\u002For laboratory\u002Fphysical examination\n* Applicable to Cohort 1 (a and b) participants only: Individuals with a history of autoimmune disease, past or present, requiring therapeutic intervention including, but not limited to, systemic lupus erythematosus. Note: Stable type 1 diabetes and hypothyroidism are permitted\n* History of severe adverse reaction associated with a vaccine and\u002For severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s)\n* Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection\n* Individuals with epilepsy or other seizure disorders that is uncontrolled\u002Funstable, or a history of seizures and\u002For other neurological complications following vaccination\n* History of Guillain-Barré syndrome and\u002For acute polyneuropathy without an underlying etiology.\n* Individuals who are pregnant\n* Any medical or psychiatric condition, including any active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality, that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study",true,"ALL","5 Years","17 Years",{"count":157,"type":158},920,"ESTIMATED","INTERVENTIONAL",[161],"PHASE3","The purpose of the study is to evaluate the safety, tolerability, and immunogenicity of RSVpreF in children 5 to \\\u003C18 years of age at high risk for RSV disease, including those who are immunocompromised.",[164],"Respiratory Syncytial Virus (RSV)",[166,167],"RSV, Vaccine","Pediatric","NOT_YET_RECRUITING","2026-09-18",{"date":171,"type":172},"2026-09-24","ACTUAL",{"date":174,"type":158},"2026-09-28",{"date":176,"type":158},"2031-04-01",{"name":5,"class":6},2]