[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07431853":3,"trial-entities:NCT07431853":231,"trial-summary:NCT07431853":235},{"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":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":62,"secondary_outcomes":76,"sex":85,"minimum_age":86,"maximum_age":17,"healthy_volunteers":87,"eligibility_criteria":88,"std_ages":95,"locations":98,"central_contacts":217,"overall_officials":223,"references":226,"see_also_links":227},"NCT07431853","C6481001","A Study to Learn About mRNA Vaccines Against Influenza in Adults","A PHASE 2, RANDOMIZED, DOUBLE-BLIND, CLINICAL STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MRNA VACCINES AGAINST INFLUENZA IN ADULTS 18 YEARS OF AGE AND OLDER","RECRUITING","2027-06-22","2026-05","2026-05-06","2026-02-23","Pfizer","INDUSTRY",false,"The purpose of this study is to learn about safety in participants taking the study vaccine (mRNA-based vaccine) and the ability of the study vaccine to trigger the body's immune response, targeting the flu virus (influenza virus).\n\nThis study is seeking healthy participants 18 years of age or older. All participants in this study will receive only 1 dose in their arm, to deliver one of the experimental flu vaccines or one of the approved flu vaccines used for comparison.\n\nParticipants will take part in this study for about 6 months, and participants will need to visit the study site at least 3 times. A blood sample will be taken at each of the 3 planned study visits and a swab from inside the nose will be taken at the first study visit.",null,[19],"Healthy Adults",[21],"Influenza vaccination","INTERVENTIONAL","PREVENTION",[25],"PHASE2",{"count":27,"type":28},770,"ESTIMATED",[30,36,40,45,49,53,57],{"type":31,"name":32,"description":33,"armGroupLabels":34},"BIOLOGICAL","Vaccine Candidate #1","Investigational influenza Vaccine",[35],"A",{"type":31,"name":37,"description":33,"armGroupLabels":38},"Vaccine Candidate #2",[39],"B",{"type":31,"name":41,"description":42,"armGroupLabels":43},"Vaccine Candidate #3","Investigational Influenza Vaccine",[44],"C",{"type":31,"name":46,"description":42,"armGroupLabels":47},"Vaccine Candidate #4",[48],"D",{"type":31,"name":50,"description":42,"armGroupLabels":51},"Vaccine Candidate #5",[52],"E",{"type":31,"name":54,"description":42,"armGroupLabels":55},"Vaccine Candidate #6",[56],"F",{"type":31,"name":58,"description":59,"armGroupLabels":60},"TIV1 or TIV2","Licensed influenza vaccine",[61],"G",[63,66,68,71,74],{"measure":64,"timeFrame":65},"Percentage of participants reporting prespecified local reactions following vaccination","Within 7 days after vaccination",{"measure":67,"timeFrame":65},"Percentage of participants reporting prespecified systemic events following vaccination.",{"measure":69,"timeFrame":70},"Percentage of participants reporting adverse events (AEs) following vaccination.","Within 1 month after vaccination",{"measure":72,"timeFrame":73},"Percentage of participants reporting serious adverse events (SAEs) following vaccination.","Within 6 months after vaccination",{"measure":75,"timeFrame":73},"Percentage of participants reporting newly diagnosed chronic medical conditions (NDCMCs) following vaccination.",[77,80,83],{"measure":78,"timeFrame":79},"Geometric Mean Titer (GMT) of Anti-Influenza Antibody Levels to each of the influenza antigens of the vaccine.","Before vaccination and at 4 weeks after vaccination",{"measure":81,"timeFrame":82},"Geometric Mean Fold Rise (GMFR) of Anti-Influenza Antibody Levels to each of the influenza antigens of the vaccine","Before vaccination to 4 weeks after vaccination",{"measure":84,"timeFrame":82},"Percentage of participants with satisfactory antibody response to the vaccine.","ALL","18 Years",true,{"inclusion":89,"exclusion":90,"raw_text":94},[],[91,92,93],"Tested positive for influenza ≤5 months (150 days) prior to Visit 1 (Day 1).","Vaccination with any investigational or licensed influenza vaccine ≤5 months (150 days) before Visit 1 (Day 1).","Receipt of antiviral therapies for influenza (eg, Tamiflu) ≤5 months (150 days) prior to Visit 1 (Day 1).","Inclusion Criteria\n\n• Healthy and medically stable participants who are determined by medical history, physical examination (if clinically required), and clinical judgment of the investigator to be eligible for inclusion in the study.\n\nExclusion Criteria\n\n* Tested positive for influenza ≤5 months (150 days) prior to Visit 1 (Day 1).\n* Vaccination with any investigational or licensed influenza vaccine ≤5 months (150 days) before Visit 1 (Day 1).\n* Receipt of antiviral therapies for influenza (eg, Tamiflu) ≤5 months (150 days) prior to Visit 1 (Day 1).",[96,97],"ADULT","OLDER_ADULT",[99,108,116,124,132,140,147,155,163,170,178,186,194,201,209],{"facility":100,"status":8,"city":101,"state":102,"zip":103,"country":104,"geoPoint":105},"AMR Clinical","Mobile","Alabama","36608","United States",{"lat":106,"lon":107},30.69436,-88.04305,{"facility":109,"status":8,"city":110,"state":111,"zip":112,"country":104,"geoPoint":113},"Diablo Clinical Research, LLC d\u002Fb\u002Fa Flourish Research","Walnut Creek","California","94598",{"lat":114,"lon":115},37.90631,-122.06496,{"facility":117,"status":8,"city":118,"state":119,"zip":120,"country":104,"geoPoint":121},"Clinical Research Consulting, LLC","Milford","Connecticut","06460",{"lat":122,"lon":123},41.22232,-73.0565,{"facility":125,"status":8,"city":126,"state":127,"zip":128,"country":104,"geoPoint":129},"George Washington Medical Faculty Associates","Washington D.C.","District of Columbia","20037",{"lat":130,"lon":131},38.89511,-77.03637,{"facility":133,"status":8,"city":134,"state":135,"zip":136,"country":104,"geoPoint":137},"Indago Research & Health Center, Inc","Hialeah","Florida","33012",{"lat":138,"lon":139},25.8576,-80.27811,{"facility":141,"status":8,"city":142,"state":135,"zip":143,"country":104,"geoPoint":144},"Palm Springs Community Health Center","Miami Lakes","33014",{"lat":145,"lon":146},25.90871,-80.30866,{"facility":148,"status":8,"city":149,"state":150,"zip":151,"country":104,"geoPoint":152},"Clinical Research Atlanta","Stockbridge","Georgia","30281",{"lat":153,"lon":154},33.54428,-84.23381,{"facility":156,"status":8,"city":157,"state":158,"zip":159,"country":104,"geoPoint":160},"East-West Medical Research Institute","Honolulu","Hawaii","96814",{"lat":161,"lon":162},21.30694,-157.85833,{"facility":100,"status":8,"city":164,"state":165,"zip":166,"country":104,"geoPoint":167},"Kansas City","Missouri","64114",{"lat":168,"lon":169},39.09973,-94.57857,{"facility":171,"status":8,"city":172,"state":173,"zip":174,"country":104,"geoPoint":175},"Rochester Clinical Research, LLC","Rochester","New York","14609",{"lat":176,"lon":177},43.15478,-77.61556,{"facility":179,"status":8,"city":180,"state":181,"zip":182,"country":104,"geoPoint":183},"DM Clinical Research - Philadelphia","Philadelphia","Pennsylvania","19107",{"lat":184,"lon":185},39.95238,-75.16362,{"facility":187,"status":8,"city":188,"state":189,"zip":190,"country":104,"geoPoint":191},"SMS Clinical Research LLC","Mesquite","Texas","75149",{"lat":192,"lon":193},32.7668,-96.59916,{"facility":195,"status":8,"city":196,"state":189,"zip":197,"country":104,"geoPoint":198},"DM Clinical Research","Tomball","77375",{"lat":199,"lon":200},30.09716,-95.61605,{"facility":202,"status":8,"city":203,"state":204,"zip":205,"country":104,"geoPoint":206},"J. Lewis Research, Inc. \u002F Foothill Family Clinic","Salt Lake City","Utah","84109",{"lat":207,"lon":208},40.76078,-111.89105,{"facility":210,"status":8,"city":211,"state":212,"zip":213,"country":104,"geoPoint":214},"Charlottesville Medical Research Center, LLC","Charlottesville","Virginia","22911",{"lat":215,"lon":216},38.02931,-78.47668,[218],{"name":219,"role":220,"phone":221,"email":222},"Pfizer CT.gov Call Center","CONTACT","1-800-718-1021","ClinicalTrials.gov_Inquiries@pfizer.com",[224],{"name":219,"affiliation":13,"role":225},"STUDY_DIRECTOR",[],[228],{"label":229,"url":230},"To obtain contact information for a study center near you, click here.","https:\u002F\u002Fpmiform.com\u002Fclinical-trial-info-request?StudyID=C6481001",{"nct_id":4,"conditions":232,"biomarkers":234},[233],"Influenza",[],{"nct_id":4,"found":87,"summary":236,"prompt_version":245},{"design":237,"status":238,"heading":6,"summary":239,"follow_up":240,"word_count":241,"commitments":242,"compensation":243,"drugs_mentioned":244},"This study is an interventional study, meaning participants will receive a specific treatment. It plans to enroll about 770 healthy adults.","completed","This study is looking for healthy adults, aged 18 and older, to help us learn more about investigational mRNA vaccines for the flu. We want to understand how safe these vaccines are and how well they help your body create an immune response against the flu virus. You will receive one dose of either an experimental flu vaccine (Vaccine Candidate #1, #2, #3, #4, or #5) or an approved flu vaccine. We will be checking for any reactions you might have after vaccination and any other side effects. The study aims to enroll about 770 participants.","Participants will be monitored for local and systemic reactions for 7 days after vaccination, and for other adverse events for up to 1 month after vaccination.",96,"You will participate for about 6 months and need to visit the study site at least 3 times. You will have blood samples taken at each visit and a nose swab at the first visit.","Not stated in the trial record.",[32],"v2"]