[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07730450":3,"trial-entities:NCT07730450":137,"trial-summary:NCT07730450":141},{"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":20,"study_type":45,"primary_purpose":46,"phases":47,"enrollment_info":49,"interventions":52,"primary_outcomes":62,"secondary_outcomes":75,"sex":76,"minimum_age":77,"maximum_age":78,"healthy_volunteers":79,"eligibility_criteria":80,"std_ages":86,"locations":88,"central_contacts":122,"overall_officials":128,"references":132,"see_also_links":133},"NCT07730450","C4591088","A Study to Learn About a COVID-19 Vaccine in Healthy Adults 18 Through 64 Years of Age","A PHASE 4, RANDOMIZED, DOUBLE-BLIND, THIRD-PARTY-UNBLINDED STUDY TO INVESTIGATE THE SAFETY AND TOLERABILITY OF A BNT162B2 RNA-BASED, VARIANT-ADAPTED VACCINE CANDIDATE AGAINST SARS-COV-2 AND EVALUATE THE CIRCULATING SARS-COV-2 SPIKE PROTEIN LEVEL IN HEALTHY PARTICIPANTS 18 THROUGH 64 YEARS OF AGE","NOT_YET_RECRUITING","2027-08-06","2026-07","2026-07-28","2026-07-23","BioNTech SE","INDUSTRY",false,"The purpose of this study is to learn about the safety and effects of an updated COVID-19 vaccine (called BNT162b2) in adults 18 to 64 years of age.\n\nThis study is seeking participants who:\n\n* are medically stable\n* have not had a recent COVID-19 infection\n* have not had a recent vaccination\n* do not have medical conditions that increase their risk of complications from COVID-19\n\nAll participants in this study will randomly receive 1 injection into their arm of either:\n\n* BNT162b2 vaccine which targets COVID-19 and is selected for the 2026-2027 COVID-19 season, or\n* Tdap vaccine which targets tetanus, diphtheria, and pertussis (whooping cough).\n\nThe study team and participants will not know which injection they receive. We will evaluate safety and SARS-CoV-2 spike protein levels in people receiving each of these vaccines.\n\nParticipants will be in the study for about 12 months.",null,[19],"COVID-19 Vaccines",[21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,19,41,42,43,44],"Pneumonia","Pneumonia, Viral","Respiratory Tract Infections","Infections","Virus Diseases","Coronavirus Infections","Coronaviridae Infections","Nidovirales Infections","RNA Virus Infections","Lung Diseases","Respiratory Tract Diseases","COVID-19","mRNA Vaccines","Nucleic Acid-Based Vaccines","Vaccines, Synthetic","Recombinant Proteins","Proteins","Amino Acids, Peptides, and Proteins","Vaccines","Biological Products","Viral Vaccines","Antigens","Biological Factors","BNT162 Vaccine","INTERVENTIONAL","PREVENTION",[48],"PHASE4",{"count":50,"type":51},200,"ESTIMATED",[53,58],{"type":54,"name":55,"description":56,"armGroupLabels":57},"BIOLOGICAL","BNT162b2 Vaccine","Participants will receive a single injection containing variant-adapted BNT162b2 on Day 1.",[55],{"type":54,"name":59,"description":60,"armGroupLabels":61},"Tdap Vaccine","Participants will receive a single injection containing Tdap on Day 1.",[59],[63,66,69,72],{"measure":64,"timeFrame":65},"Percentage of participants reporting local reactions or systemic events","From Day 1 up to 7 days after Vaccination",{"measure":67,"timeFrame":68},"Percentage of participants reporting adverse events","From Day 1 through 1 month after vaccination",{"measure":70,"timeFrame":71},"Percentage of participants reporting serious adverse events","From Day 1 through 12 months after vaccination",{"measure":73,"timeFrame":74},"Spike protein levels","Up to 12 months after vaccination",[],"ALL","18 Years","64 Years",true,{"inclusion":81,"exclusion":82,"raw_text":85},[],[83,84],"Participants who tested positive for COVID-19 within 6 months (180 days) prior to Visit 1","Participants who have recently received a vaccine, or plan to receive a nonstudy COVID-19 or comparator vaccine during participation.","Key Inclusion Criteria\n\n\\- Healthy participants 18 through 64 years of age who do not have medical conditions that put them at a higher risk for severe COVID-19.\n\nKey Exclusion Criteria\n\n* Participants who tested positive for COVID-19 within 6 months (180 days) prior to Visit 1\n* Participants who have recently received a vaccine, or plan to receive a nonstudy COVID-19 or comparator vaccine during participation.\n\nThe complete list of inclusion and exclusion criteria are listed in the protocol.",[87],"ADULT",[89,98,106,114],{"facility":90,"city":91,"state":92,"zip":93,"country":94,"geoPoint":95},"Diablo Clinical Research, LLC dba Flourish Research","Walnut Creek","California","94598","United States",{"lat":96,"lon":97},37.90631,-122.06496,{"facility":99,"city":100,"state":101,"zip":102,"country":94,"geoPoint":103},"Palm Springs Community Health Center","Miami Lakes","Florida","33014",{"lat":104,"lon":105},25.90871,-80.30866,{"facility":107,"city":108,"state":109,"zip":110,"country":94,"geoPoint":111},"East-West Medical Research Institute","Honolulu","Hawaii","96814",{"lat":112,"lon":113},21.30694,-157.85833,{"facility":115,"city":116,"state":117,"zip":118,"country":94,"geoPoint":119},"J. Lewis Research, Inc. \u002F Foothill Family Clinic","Salt Lake City","Utah","84109",{"lat":120,"lon":121},40.76078,-111.89105,[123],{"name":124,"role":125,"phone":126,"email":127},"Pfizer CT.gov Call Center","CONTACT","1-800-718-1021","ClinicalTrials.gov_Inquiries@pfizer.com",[129],{"name":124,"affiliation":130,"role":131},"Pfizer","STUDY_DIRECTOR",[],[134],{"label":135,"url":136},"To obtain contact information for a study center near you, click here.","https:\u002F\u002Fpmiform.com\u002Fclinical-trial-info-request?StudyID=C4591088",{"nct_id":4,"conditions":138,"biomarkers":140},[139],"COVID-19 Infection",[],{"nct_id":4,"found":79,"summary":142,"prompt_version":152},{"design":143,"status":144,"heading":145,"summary":146,"follow_up":147,"word_count":148,"commitments":149,"compensation":150,"drugs_mentioned":151},"This is an interventional study where participants will randomly receive one of two vaccines. The study plans to enroll 200 participants.","completed","A Study of an Updated COVID-19 Vaccine in Healthy Adults","This study is looking at the safety and effects of an updated COVID-19 vaccine called BNT162b2 in healthy adults aged 18 to 64. You might be able to join if you are medically stable, haven't had COVID-19 recently, and haven't received another vaccine recently. Participants will receive one injection of either the BNT162b2 vaccine or a Tdap vaccine (for tetanus, diphtheria, and whooping cough). Neither you nor the study team will know which vaccine you receive. Researchers will check for any reactions or side effects to understand how safe the vaccines are. The study aims to enroll 200 people, but its current recruitment status is unclear.","Participants will be followed for serious adverse events for up to 12 months after vaccination.",106,"Participants will receive a single injection on Day 1. Researchers will monitor for local reactions and systemic events for 7 days, and for adverse events for 1 month.","Not stated in the trial record.",[55,59],"v2"]