[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654228":3},{"organization":4,"outcomesModule":7,"designInfo":29,"detailedDescription":11,"studyPopulation":11,"armGroups":40,"interventions":73,"overallOfficials":85,"centralContacts":90,"locations":95,"responsibleParty":229,"collaborators":231,"id":233,"slug":234,"hasResults":235,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":11,"eligibilityCriteria":239,"healthyVolunteers":240,"sex":241,"minAge":242,"maxAge":11,"enrollmentInfo":243,"targetDuration":11,"studyType":246,"phases":247,"briefSummary":249,"conditions":250,"keywords":252,"overallStatus":98,"whyStopped":11,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":286},{"fullName":5,"class":6},"BioNTech SE","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":22,"otherOutcomes":11},[9,13,16,19],{"measure":10,"description":11,"timeFrame":12},"Percentage of participants reporting local reactions or systemic events",null,"For up to 7 days after vaccination",{"measure":14,"description":11,"timeFrame":15},"Percentage of participants reporting adverse events","Through 1 month after vaccination",{"measure":17,"description":11,"timeFrame":18},"Percentage of participants reporting serious adverse events","Through 6 months after vaccination",{"measure":20,"description":11,"timeFrame":21},"Geometric Mean Fold Rise (GMFRs)","From baseline to 1 month after vaccination",[23,26],{"measure":24,"description":11,"timeFrame":25},"Geometric Mean Titers (GMTs)","At baseline and at 1 month after vaccination",{"measure":27,"description":11,"timeFrame":28},"Percentage of participants with seroresponse","At 1 month after vaccination",{"allocation":30,"interventionModel":31,"interventionModelDescription":11,"primaryPurpose":32,"observationalModel":11,"timePerspective":11,"maskingInfo":33},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":34,"maskingDescription":35,"whoMasked":36},"TRIPLE","Cohort 1 - No Masking; Cohort 2 - Masking applies: Double Blind, Third-party Unblinded (Participant, Care Provider, Investigator)",[37,38,39],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR",[41,47,51,54,58,61,64,67,70],{"label":42,"type":43,"description":44,"interventionNames":45},"Cohort 1 Group 1: 5-11 Years (with risk factors)","EXPERIMENTAL","Participants will receive a single injection (age appropriate dose) on Day 1",[46],"Biological: BNT162b2",{"label":48,"type":43,"description":49,"interventionNames":50},"Cohort 1 Group 3: ≥65 Years","Participants will receive a single injection (age appropriate dose) on Day 1.",[46],{"label":52,"type":43,"description":44,"interventionNames":53},"Cohort 1 Group 2: 12-64 Years (with risk factors)",[46],{"label":55,"type":43,"description":56,"interventionNames":57},"Cohort 2 Group 5: 18-64 Years (with risk factors)","Participants will receive a single injection containing variant-adapted BNT162b2 on Day 1",[46],{"label":59,"type":43,"description":56,"interventionNames":60},"Cohort 2 Group 4: 18-64 Years (with risk factors)",[46],{"label":62,"type":43,"description":56,"interventionNames":63},"Cohort 2 Group 6: 18-64 Years (with risk factors)",[46],{"label":65,"type":43,"description":56,"interventionNames":66},"Cohort 2 Group 7: ≥65 Years",[46],{"label":68,"type":43,"description":56,"interventionNames":69},"Cohort 2 Group 8: ≥65 Years",[46],{"label":71,"type":43,"description":56,"interventionNames":72},"Cohort 2 Group 9: ≥65 Years",[46],[74,79,82],{"type":75,"name":76,"description":77,"armGroupLabels":78,"otherNames":11},"BIOLOGICAL","BNT162b2","BNT162b2 vaccine 1 (2026\u002F2027 recommended 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States","US",{"type":105,"coordinates":106},"Point",[107,108],-80.47756,25.46872,{"lat":108,"lon":107},{"facility":111,"status":98,"city":112,"state":100,"zip":113,"country":102,"countryCode":103,"cosmosGeoPoint":114,"geoPoint":118,"contacts":11},"Indago Research & Health Center, Inc","Miami Lakes","33016",{"type":105,"coordinates":115},[116,117],-80.30866,25.90871,{"lat":117,"lon":116},{"facility":120,"status":98,"city":121,"state":122,"zip":123,"country":102,"countryCode":103,"cosmosGeoPoint":124,"geoPoint":128,"contacts":11},"AGILE Clinical Research Trials, LLC","Atlanta","Georgia","30328",{"type":105,"coordinates":125},[126,127],-84.38798,33.749,{"lat":127,"lon":126},{"facility":130,"status":98,"city":131,"state":132,"zip":133,"country":102,"countryCode":103,"cosmosGeoPoint":134,"geoPoint":138,"contacts":11},"East-West Medical Research Institute","Honolulu","Hawaii","96814",{"type":105,"coordinates":135},[136,137],-157.85833,21.30694,{"lat":137,"lon":136},{"facility":140,"status":98,"city":141,"state":142,"zip":143,"country":102,"countryCode":103,"cosmosGeoPoint":144,"geoPoint":148,"contacts":11},"Kentucky Pediatric \u002FAdult Research","Bardstown","Kentucky","40004",{"type":105,"coordinates":145},[146,147],-85.4669,37.80923,{"lat":147,"lon":146},{"facility":150,"status":98,"city":151,"state":152,"zip":153,"country":102,"countryCode":103,"cosmosGeoPoint":154,"geoPoint":158,"contacts":11},"Dayton Clinical Research","Dayton","Ohio","45409",{"type":105,"coordinates":155},[156,157],-84.19161,39.75895,{"lat":157,"lon":156},{"facility":160,"status":98,"city":161,"state":152,"zip":162,"country":102,"countryCode":103,"cosmosGeoPoint":163,"geoPoint":167,"contacts":11},"Senders Pediatrics","South Euclid","44121",{"type":105,"coordinates":164},[165,166],-81.51846,41.52311,{"lat":166,"lon":165},{"facility":169,"status":98,"city":170,"state":171,"zip":172,"country":102,"countryCode":103,"cosmosGeoPoint":173,"geoPoint":177,"contacts":11},"DM Clinical Research","Philadelphia","Pennsylvania","19107",{"type":105,"coordinates":174},[175,176],-75.16362,39.95238,{"lat":176,"lon":175},{"facility":179,"status":98,"city":180,"state":181,"zip":182,"country":102,"countryCode":103,"cosmosGeoPoint":183,"geoPoint":187,"contacts":11},"Cedar Health Research","Dallas","Texas","75251",{"type":105,"coordinates":184},[185,186],-96.80667,32.78306,{"lat":186,"lon":185},{"facility":179,"status":98,"city":189,"state":181,"zip":190,"country":102,"countryCode":103,"cosmosGeoPoint":191,"geoPoint":195,"contacts":11},"Euless","76040",{"type":105,"coordinates":192},[193,194],-97.08195,32.83707,{"lat":194,"lon":193},{"facility":197,"status":98,"city":198,"state":181,"zip":199,"country":102,"countryCode":103,"cosmosGeoPoint":200,"geoPoint":204,"contacts":11},"DM Clinical Research-Cyfair","Houston","77065",{"type":105,"coordinates":201},[202,203],-95.36327,29.76328,{"lat":203,"lon":202},{"facility":169,"status":98,"city":206,"state":181,"zip":207,"country":102,"countryCode":103,"cosmosGeoPoint":208,"geoPoint":212,"contacts":11},"Tomball","77375",{"type":105,"coordinates":209},[210,211],-95.61605,30.09716,{"lat":211,"lon":210},{"facility":214,"status":98,"city":215,"state":216,"zip":217,"country":102,"countryCode":103,"cosmosGeoPoint":218,"geoPoint":222,"contacts":11},"J. Lewis Research, Inc. \u002F Foothill Family Clinic","Salt Lake City","Utah","84109",{"type":105,"coordinates":219},[220,221],-111.89105,40.76078,{"lat":221,"lon":220},{"facility":224,"status":98,"city":215,"state":216,"zip":225,"country":102,"countryCode":103,"cosmosGeoPoint":226,"geoPoint":228,"contacts":11},"J. Lewis Research, Inc. \u002F Foothill Family Clinic South","84121",{"type":105,"coordinates":227},[220,221],{"lat":221,"lon":220},{"type":230,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[232],{"name":88,"class":6},"100654228","phase-3-a-study-of-covid-19-vaccines-in-children-and-adults-100654228",false,"NCT07798648","A Study of COVID-19 Vaccine(s) in Children and Adults","A PHASE 3 CLINICAL STUDY EVALUATING THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF BNT162B2 RNA-BASED, VARIANT-ADAPTED VACCINE CANDIDATE(S) AGAINST SARS-COV-2 IN CHILDREN AND ADULTS","Key Inclusion criteria:\n\n* Participants 5 years of age or older.\n* Participants 5 through 64 years of age should have at least 1 underlying medical condition that increases their risk of severe COVID-19.\n\nKey Exclusion Criteria:\n\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* History of myocarditis or pericarditis.\n* Receipt of a COVID-19 vaccine or a confirmed case of COVID-19 (confirmed by signs\u002Fsymptoms and\u002For a positive test result based on local testing) less than 3 months (90 days) prior to study enrolment.\n\nRefer to the study contact for further eligibility details.",true,"ALL","5 Years",{"count":244,"type":245},700,"ESTIMATED","INTERVENTIONAL",[248],"PHASE3","The purpose of this study is to learn about the safety and effects of updated COVID-19 vaccines (called BNT162b2) in participants 5 Through 64 Years of Age with risk factors for Severe COVID-19, and Participants 65 Years of Age and Older.\n\nThis study is seeking participants who:\n\n* are medically stable\n* have not had a recent COVID-19 infection or a recent COVID-19 vaccination\n* have not received certain routine vaccines recently\n* participants that are 5 through 64 years of age will need to have at least 1 medical condition that increase their risk of complications from COVID-19.\n\nParticipants in Cohort 1 of this study will receive a single age-appropriate dose (30 mcg for participants aged ≥12 years; 10 mcg for participants aged 5-11 years) of BNT162b2 vaccine 1 which targets COVID-19 (2026\u002F2027 recommended strain) injected in the upper arm. The study team and participants will know which injection they receive.\n\nParticipants in Cohort 2 of this study will randomly receive 1 injection into their upper arm of either: BNT162b2 vaccine 1; BNT162b2 vaccine 2, or BNT162b2 vaccine 3 which targets COVID-19. The study team and participants will not know which injection they receive.\n\nParticipants will be in the study for about 6 months and will have at least 3 study visits. Participants will record side effects and complete diaries following visit procedures. For Cohort 1 the study team will collect a nose swab and blood samples at 2 of the 3 visits. For Cohort 2 the study team will collect a nose swab and blood samples at all of the visits.",[251],"COVID-19 Vaccines",[253,254,255,256,257,258,259,260,261,262,263,264,265,266,267,268,269,270,271,272,251,273,274,275,276],"Pneumonia","Respiratory Tract Infections","Pneumonia,Viral","Infections","Virus Diseases","Coronavirus Infections","Coronaviridae Infections","Nidovirales Infections","RNA Virus Infections","Lung Diseases","Respiratory Tract Diseases","COVID-19","mRNA Vaccines","Nucleic Acid-Based Vaccine","Vaccines, Synthetic","Recombinant Proteins","Proteins","Amino Acids, Peptides, and Proteins","Vaccines","Biological Products","Viral Vaccines","Antigens","Biological Factors","BNT162 Vaccine","2026-09-23",{"date":279,"type":280},"2026-09-28","ACTUAL",{"date":282,"type":280},"2026-08-31",{"date":284,"type":245},"2027-04-21",{"name":5,"class":6},14]