[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"ModernaTX, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":350},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,46,76,102,132,165,196,223,248,280,302,324],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100601908","phase-1-a-study-of-mrna-2808-in-participants-with-relapsed-or-refractory-multiple-myeloma-100601908",false,"NCT07116616","A Study of mRNA-2808 in Participants With Relapsed or Refractory Multiple Myeloma","A Phase 1\u002F2, Open-label, Multicenter Study of mRNA-2808 in Participants With Relapsed or Refractory Multiple Myeloma","Key Inclusion Criteria:\n\n* RRMM with prior exposure to a proteasome inhibitor, an immunomodulatory drug (IMiD), and an anti-cluster of differentiation (CD38) monoclonal antibody.\n* Measurable disease defined as at least 1 of the following:\n\n  * Serum M-protein ≥0.5 grams\u002Fdeciliter\n  * Urine M-protein ≥200 milligrams (mg)\u002F24-hour\n  * Involved free light chain (FLC) ≥100 mg\u002Fliter and an abnormal FLC ratio\n  * Plasmacytoma with a single diameter ≥2 centimeters\n  * Bone marrow plasma cells \\>30%\n\nKey Exclusion Criteria:\n\n* Known central nervous system (CNS) myeloma or clinical signs and symptoms of CNS involvement of myeloma.\n* Active plasma cell leukemia, defined as peripheral blood plasma cells ≥20%.\n* Radiotherapy or cytotoxic chemotherapy within 2 weeks prior to Day 1 (Baseline), except palliative radiotherapy of limited field is permissible within 2 weeks after discussion with the Sponsor medical monitor.\n* Antibody-based immunotherapy (monoclonal antibody, bispecific antibody, antibody drug conjugate) within 21 days prior to Day 1 (Baseline).\n* Proteasome inhibitor therapy or immunomodulatory agent within 14 days prior to Day 1 (Baseline).\n* Autologous hematopoietic cell transplant within 100 days prior to Day 1 (Baseline).\n* Allogeneic hematopoietic cell transplant within 180 days prior to Day 1 (Baseline).\n* Genetically modified adoptive autologous or allogeneic cellular therapy (for example, chimeric antigen receptor T cell, chimeric antigen receptor natural killer) within 12 weeks prior to Day 1 (Baseline).\n* Corticosteroid therapy ≥140 mg prednisone or equivalent cumulative dose within 14 days prior to Day 1 (Baseline).\n\nNote: Other inclusion and exclusion criteria may apply.","ALL","18 Years",{"count":19,"type":20},166,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The purpose of this study is to evaluate the safety and tolerability of mRNA-2808 in participants with relapsed or refractory multiple myeloma (RRMM).",[27],"Relapsed or Refractory Multiple Myeloma",[29,30,31,32],"relapsed or refractory multiple myeloma","RRMM","multiple myeloma","MM","RECRUITING","2026-06-25",{"date":36,"type":37},"2026-06-29","ACTUAL",{"date":39,"type":37},"2025-09-30",{"date":41,"type":20},"2032-06-17",{"name":43,"class":44},"ModernaTX, Inc.","INDUSTRY",10,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},"100480262","phase-1-study-of-mrna-4359-administered-alone-and-in-combination-with-immune-checkpoint-blockade-in-participants-with-advanced-solid-tumors-100480262","NCT05533697","Study of mRNA-4359 Administered Alone and in Combination With Immune Checkpoint Blockade in Participants With Advanced Solid Tumors","Phase 1\u002F2 Study of mRNA-4359 Administered Alone and in Combination With Immune Checkpoint Blockade in Participants With Advanced Solid Tumors","Key Inclusion Criteria:\n\n* Males or females ≥18 years of age who have provided written informed consent prior to completing any study-specific procedure. For Arm 2d, participants ≥12 years are eligible with informed consent\u002Fassent.\n* Dose Escalation (Arm 1a): Participant has histologically confirmed locally advanced or metastatic cancer (cutaneous melanoma, NSCLC, non-muscle invasive bladder cancer, head and neck squamous cell carcinoma, microsatellite stable colorectal cancer \\[MSS CRC\\], basal cell carcinoma, or triple negative breast cancer) with measurable disease as determined by RECIST v1.1. Arm 1a participants must have received, and then progressed, relapsed, or been intolerant to, or ineligible for, at least 1 standard treatment regimen in the advanced or metastatic setting. Participants with a known driver mutation must have also received or been offered a mutation-directed therapy, where indicated. Participants must have a tumor lesion amenable to biopsy and must have another lesion that can be followed for response.\n* Dose Confirmation (Arm 1b): Participant has histologically confirmed locally advanced or metastatic, and CPI refractory melanoma or locally advanced or metastatic, and CPI refractory NSCLC with measurable disease as determined by RECIST v1.1 who has disease progression after, at least 1 line of standard therapy (no limit to prior lines of therapy), and has been treated with or refused standard of care treatment. Participants in PD arm Group 2 must also have PD-L1 TPS ≥1%. Participants must have primary refractory or acquired secondary resistance to prior immune checkpoint treatments. Primary refractory is defined as prior exposure to anti-programmed death-1 (PD-1)\u002FPD-L1 antibody for at least 6 weeks but no more than 6 months with demonstration of progression on 2 separate scans at least 4 weeks apart but no more than 12 weeks apart and progression occurring within 6 months after first dose of anti-PD-1 antibody. Acquired secondary resistance must have confirmed objective response or prolonged stable disease (SD) (\\>6 months), followed by disease progression in the setting of ongoing treatment and confirmed progression on scans at least 4 weeks apart. Participants must have a tumor lesion amenable to biopsy and must have another lesion that can be followed for response.\n\n  1. For NSCLC participants with known EGFR, ALK, proto-oncogene tyrosine-protein kinase reactive oxygen species (ROS1), or other actionable mutations for which there are approved targeted therapies, participants must have received prior approved targeted therapy or have been offered and declined approved targeted therapy.\n  2. Expansion of the melanoma Arm 1b cohort (up to approximately 16 additional evaluable participants) will require prospective central testing of Screening tumor biopsies to confirm PD-L1 TPS ≥1% for eligibility.\n* Dose Expansion Arms (Arm 2): Participant has histologically confirmed:\n\n  1. Arm 2a: Locally advanced or metastatic melanoma who have not yet received any prior systemic therapy for their melanoma in this setting.\n  2. Arm 2b: Newly diagnosed locally advanced or metastatic NSCLC with a PD-L1 TPS of ≥50% with no known EGFR or ALK positive tumor mutations who have not yet received any prior systemic therapy for their NSCLC (that is, treatment-naive).\n  3. Arm 2c: Locally advanced or metastatic melanoma in participants who have not received prior systemic therapy for melanoma in the advanced\u002Fmetastatic setting.\n  4. Arm 2d: Advanced\u002Fmetastatic melanoma that is CPI refractory and having a centrally confirmed PD-L1 TPS of ≥1% on their Screening tumor biopsy.\n* All participants must have measurable disease as determined by RECIST v1.1.\n* Participants must have a tumor lesion amenable to biopsy and must provide tumor biopsy sample at baseline (archival formalin-fixed, paraffin-embedded \\[FFPE\\] tissue collected within 90 days of informed consent is accepted as long as no intervening therapy is received, during this time), and optionally at all on-treatment timepoints (including response or progression) if medically feasible. Participants in Arm 2c: Sufficient tumor tissue (slides or FFPE block) for PD-L1 testing is required as per Laboratory Manual. Participants in Arm 2c may be replaced in this cohort if not PD-L1 evaluable. Participants in Arm 1b melanoma expansion cohort and Arm 2d: Central confirmation of PD-L1 TPS score is required prior to enrollment.\n* If the participant is undergoing a new biopsy, they must have another lesion outside of the lesion biopsied at baseline that can be followed as a RECIST v1.1 target lesion for response.\n* Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.\n* Participant has adequate hematological and biological function.\n\nKey Exclusion Criteria:\n\n* Participant has active central nervous system tumors or metastases.\n* Participant has received treatment with prohibited medications (that is, concurrent anticancer therapy including other chemotherapy, radiation \\[local radiation for palliative care is permitted with approval from the Sponsor\\], hormonal anticancer treatment, biologic therapy, or immunotherapy) or investigational agents within 5 half-lives or 14 days prior to the first day of study treatment, whichever is shorter. Prior exposure to any investigational or approved agent designed to simultaneously target both indoleamine 2,3-dioxygenase (IDO1) and PD-L1 is also exclusionary.\n* Participant has required the use of additional immunosuppression (for example, infliximab) other than corticosteroids for the management of an AE, has experienced recurrence of an AE if rechallenged, and currently requires maintenance doses of \\>10 milligrams (mg) prednisone or equivalent per day.\n* Participant has any plan to receive a live attenuated vaccine during study treatment or has received a live vaccine within 30 days before the first dose of study treatment. Examples of live vaccines include, but are not limited to measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin, and typhoid vaccine. Seasonal influenza vaccines and non-live coronavirus disease 2019 (COVID-19) for injection are generally allowed.\n* Participant has reversible toxicities from prior cancer therapy that have not recovered to Grade 1 or baseline. Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and prespecified laboratory values.\n* Participant who is pregnant, breastfeeding, or is of childbearing potential, defined as those who are capable of becoming pregnant who are not willing to employ a highly effective method of contraception during dosing and for 90 days after the last dose of mRNA-4359 or 4 months after the last dose of pembrolizumab or 5 months after the last dose of ipilimumab\u002Fnivolumab administrations, whichever is longer.\n* Sexually active participants who refuse to use a condom during intercourse or participants who will not refrain from sperm donation while taking study treatment and for 90 days after the last dose of mRNA-4359 or 4 months after the last dose of pembrolizumab or 5 months after the last dose ipilimumab\u002Fnivolumab, whichever is longer, or who will not refrain from sperm donation for the same time period.\n* Participant has any unstable or clinically significant concurrent medical condition (for example, substance abuse, uncontrolled intercurrent illness including active infection, arterial thrombosis, and symptomatic pulmonary embolism) that would, in the opinion of the Investigator, jeopardize the safety of a participant, impact their expected survival through the end of the study participation, and\u002For impact their ability to comply with the protocol. Also including but not limited to, ongoing or active infection, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, active gastrointestinal bleeding or hemoptysis or history of bleeding disorder, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring AEs, or compromise the ability of the participant to give written informed consent.\n* Participant has concurrent enrollment in another clinical study (unless it is an observational noninterventional clinical study).","12 Years",{"count":55,"type":20},361,[23,24],"The primary goal of this study is to assess the safety and tolerability of mRNA-4359 administered alone and in combination with pembrolizumab or ipilimumab and nivolumab.",[59],"Advanced Solid Tumors",[61,62,63,64,65,66],"Locally advanced","Metastatic","Relapsed or refractory solid tumor malignancies","Pembrolizumab","Oncology","Solid tumors","2026-06-22",{"date":69,"type":37},"2026-06-23",{"date":71,"type":37},"2022-09-01",{"date":73,"type":20},"2032-02-18",{"name":43,"class":44},34,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":21,"phases":86,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},"100572590","phase-2-a-study-to-investigate-multiple-sclerosis-relapse-prevention-with-mrna-1195-compared-with-placebo-in-participants-aged-18-to-55-years-100572590","NCT06735248","A Study to Investigate Multiple Sclerosis Relapse Prevention With mRNA-1195 Compared With Placebo in Participants Aged 18 to ≤55 Years","A Phase 2, Randomized, Observer-Blind, Placebo-Controlled, Dose-Ranging Study of mRNA-1195 Intramuscular Injection in Participants 18 to ≤55 Years of Age With Multiple Sclerosis","Inclusion Criteria:\n\n* Medically stable as determined by Investigator's medical evaluation, which will include assessment of medical history, physical examination, laboratory testing, and review of any previously conducted cardiac monitoring.\n* Participants who are Epstein-Barr virus (EBV)-seropositive at screening.\n* Participants diagnosed with relapsing multiple sclerosis, including those with a single clinical attack (that is, clinically isolated syndrome \\[CIS\\]), as well as participants diagnosed with radiologically isolated syndrome, within 24 months of Screening Visit (that is, early in their multiple sclerosis course) and in the opinion of the Investigator have been neurologically stable for at least 30 days prior to Visit 1\u002FDay 1.\n* A participant who could become pregnant is eligible to participate if they are not pregnant or breast\u002Fchest feeding and using a highly effective contraceptive method.\n\nExclusion Criteria:\n\n* Acutely ill or febrile (temperature ≥38.0 degrees Celsius (℃) \\[100.4 Fahrenheit °F\\]) within 72 hours prior to or at screening or Day 1.\n* History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable or may affect participant safety, assessment of study endpoints, assessment of immune response, or adherence to study procedures.\n* Received or plans to receive any non-study vaccine (including authorized or approved vaccines for the prevention of coronavirus disease 2019 \\[COVID-19\\] regardless of vaccine type) within 28 days before or after any study injection, or within 14 days before or after any study injection for the influenza vaccine.\n* Any medical, psychiatric, or occupational condition, including reported history of drug or alcohol abuse, that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results.\n* Received systemic immunosuppressants within the 30 day period prior to screening (for corticosteroids, ≥10 milligrams (mg)\u002Fday of prednisone or equivalent)\n* Participants with any documented history of myocarditis, pericarditis, or myopericarditis.\n* Has donated ≥450 milliliter (mL) of blood products within 28 days prior to screening or plans to donate blood products within 28 days post-study injection.\n\nNote: Other inclusion and exclusion criteria may apply.","55 Years",{"count":85,"type":20},180,[24],"The primary objective of this trial is to evaluate the safety and reactogenicity of mRNA-1195 in participants with multiple sclerosis.",[89],"Multiple Sclerosis",[89,91,92],"mRNA-1195","MS","2026-06-11",{"date":95,"type":37},"2026-06-15",{"date":97,"type":37},"2025-04-16",{"date":99,"type":20},"2029-01-08",{"name":43,"class":44},17,{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":109,"sex":16,"minAge":17,"maxAge":110,"enrollmentInfo":111,"targetDuration":4,"studyType":21,"phases":113,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},"100636100","phase-2-a-study-to-evaluate-the-safety-reactogenicity-and-immunogenicity-of-mrna-1982-to-prevent-lyme-disease-in-healthy-participants-18-to-70-years-of-age-100636100","NCT07561294","A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1982 to Prevent Lyme Disease in Healthy Participants (18 to 70 Years of Age)","A Phase 2, Randomized, Observer-blind, Dose-finding, Placebo-controlled Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1982, an mRNA Vaccine to Prevent Lyme Disease in Healthy Adult Participants (18 to 70 Years of Age)","Key Inclusion Criteria:\n\n* In good general health in the opinion of the investigator as determined by medical evaluation including medical history and physical examination at screening.\n* Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\nKey Exclusion Criteria:\n\n* History of anaphylaxis or severe hypersensitivity reaction requiring medical intervention after receipt of any mRNA vaccine or therapeutic or any components of an mRNA vaccine or therapeutic.\n* Have chronic illness related to Lyme disease or an active symptomatic Lyme disease infection as suspected or diagnosed by a physician.\n* Received treatment for Lyme disease within the prior 3 months.\n* Previously vaccinated against Lyme disease or participated in the past in any vaccine study for Lyme disease.\n* Had a tick bite within 4 weeks prior to Day 1.\n\nNote: Additional inclusion\u002Fexclusion criteria may apply, per protocol.",true,"70 Years",{"count":112,"type":20},350,[24],"This clinical study will evaluate the safety, reactogenicity, and immunogenicity of monovalent mRNA-1982, a messenger ribonucleic acid (mRNA) vaccine to prevent Lyme disease in healthy adults aged 18 to 70 years old.",[116],"Lyme Disease",[118,119,120,121,122],"Moderna","mRNA-1982","Messenger RNA","Safety","Vaccines","2026-05-27",{"date":125,"type":37},"2026-05-28",{"date":127,"type":37},"2026-04-29",{"date":129,"type":20},"2028-11-09",{"name":43,"class":44},8,{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":109,"sex":16,"minAge":53,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":21,"phases":141,"briefSummary":143,"conditions":144,"keywords":146,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":164},"100599839","phase-4-a-study-to-evaluate-the-immunogenicity-and-safety-of-mrna-1283-covid-19-variant-containing-formulations-100599839","NCT07089706","A Study to Evaluate the Immunogenicity and Safety of mRNA-1283 COVID-19 Variant-containing Formulations","A Phase 3b\u002F4, Open-label Study to Evaluate the Immunogenicity and Safety of mRNA-1283 COVID-19 Variant-containing Vaccine Formulations","Inclusion Criteria:\n\nSubprotocol 1:\n\n* ≥65 years of age at the time of signing the informed consent or ≥12 to \\\u003C65 years of age at the time of signing the informed consent with at least 1 risk factor for severe outcomes from COVID-19.\n* Investigator's assessment that the participant understands and is willing and physically able to comply with protocol-mandated follow-up, including all procedures.\n* Participants who are assigned female at birth or could become pregnant:\n\n  i) Has a negative pregnancy test at the Screening Visit and on the day of vaccination prior to vaccine dose being administered on Day 1.\n\nii) Has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first dose (Day 1).\n\niii) Has agreed to continue adequate contraception through 28 days following vaccine administration.\n\nExclusion Criteria:\n\nSubprotocol 1:\n\n* History of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 6 months prior to enrollment.\n* Acutely ill or febrile (temperature ≥38.0°Celsius\u002F≥100.4°Fahrenheit) within 72 hours prior to or at the Screening Visit or Day 1. Participants meeting this criterion may be rescheduled within the Screening window and will retain their initially assigned participant number.\n* History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable or may affect participant safety, assessment of study endpoints, assessment of immune response, or adherence to study procedures.\n* Receipt of the COVID-19 vaccine within 6 months prior to enrollment.\n* Receipt of any licensed non-COVID-19 vaccine within 28 days before or planned receipt within 28 days after the study intervention, except an influenza vaccine, which may be given 14 days before or after receipt of the study intervention.\n* Receipt of systemic immunosuppressants for \\>14 days in total, within 180 days prior to Screening Visit (for corticosteroids ≥10 milligrams \\[mg\\]\u002Fday of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study.\n* Receipt of systemic immunoglobulins, long-acting biological therapies that affect immune responses (for example, infliximab) or blood products within 90 days prior to the Screening Visit or plans to receive them during the study.\n* History of anaphylaxis or severe hypersensitivity reaction requiring medical intervention after receipt of any mRNA vaccine or therapeutic or any components of an mRNA vaccine or therapeutic.\n* Has donated ≥450 milliliters (mL) of blood products within 28 days prior to the Screening Visit or plans to donate blood products within 28 days after the study injection.\n\nNote: Other protocol-specified inclusion and exclusion criteria may apply.",{"count":140,"type":20},832,[142],"PHASE4","The purpose of this study is to evaluate the immunogenicity and safety of the recommended variant-containing formulations of mRNA-1283 COVID-19 vaccine (mNEXSPIKE®) within the current epidemiological environment.",[145],"COVID-19",[147,148,149,150,151,152,153,154,145,155,118],"mRNA-1283","mRNA-1283 vaccine","SARS-CoV-2","SARS-CoV-2 Vaccine","Coronavirus","Coronavirus Infections","Virus Diseases","mNEXSPIKE®","COVID-19 vaccine","2026-05-15",{"date":158,"type":37},"2026-05-19",{"date":160,"type":37},"2025-07-21",{"date":162,"type":20},"2026-06-19",{"name":43,"class":44},5,{"id":166,"slug":167,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":4,"eligibilityCriteria":171,"healthyVolunteers":109,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":172,"targetDuration":4,"studyType":21,"phases":174,"briefSummary":176,"conditions":177,"keywords":179,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":195},"100631113","phase-3-a-study-of-mrna-1018-h5-pandemic-influenza-vaccine-in-healthy-adults-100631113","NCT07496450","A Study of mRNA-1018-H5 Pandemic Influenza Vaccine in Healthy Adults","A Phase 3, Randomized, Observer-blind, Placebo-controlled Study to Evaluate the Immunogenicity, Safety, and Reactogenicity of mRNA-1018-H5 Pandemic Influenza Vaccine in Adults ≥18 Years of Age","Key Inclusion Criteria:\n\n* Healthy as determined by medical evaluation including medical history; and physical examination. Participants with clinically stable chronic medical conditions are permitted.\n* Participants who are assigned female at birth or could become pregnant are eligible to participate if the participant is not pregnant or breast\u002Fchest feeding, and one of the following conditions applies:\n\n  * Is a person of nonchildbearing potential (PONCBP) OR\n  * Is a person of childbearing potential (POCBP)\n  * A POCBP must have a negative highly sensitive pregnancy test at Screening and on the day of the first dose of study intervention.\n\nKey Exclusion Criteria:\n\n* Participant is acutely ill or febrile (body temperature ≥ 38.0 degrees Celsius \\[°C\\]\u002F100.4 degrees Fahrenheit \\[°F\\]) within 72 hours prior to or at the Screening Visit or Day 1.\n* History of myocarditis, pericarditis, or myopericarditis.\n* History of Guillain-Barre syndrome.\n* Reported history of congenital or acquired immunodeficiency, immunosuppressive condition, asplenia, or recurrent severe infections disease.\n* Treated with antiviral therapies for influenza (eg, Tamiflu, Xofluza) within 28 days prior to Day 1.\n* Prior receipt of a pandemic influenza vaccine or participation in any pandemic influenza vaccine clinical study, including the mRNA-1018-P101 study.\n* Any medical, psychiatric, or occupational condition, that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with adherence to study procedures or the interpretation of study results.\n* Participant has received systemic immunosuppressants including long-acting biological therapies that affect immune responses (eg, infliximab, methotrexate, omalizumab, etc.), within 180 days prior to Screening or plans to do so at any time during participation in the study.\n* Participant has received corticosteroids at ≥10 mg\u002Fday of prednisone or equivalent for \\>14 days in total within 90 days prior to Day 1 (Baseline) or is anticipating the need for corticosteroids at any time during the study.\n* Participants has received any licensed vaccine authorized or approved by local health agency including mRNA vaccine ≤28 days prior to study intervention (Day 1) or plans to receive a vaccine authorized or approved by local health agency within 21 days after the study intervention.\n* Participant has participated in an interventional clinical study within 90 days prior to the Screening visit based on the medical history interview or plans to do so while participating in this study.\n\nNote: Other inclusion\u002Fexclusion criteria may apply.",{"count":173,"type":20},4000,[175],"PHASE3","The purpose of this study is to evaluate humoral immunogenicity after 2 doses of mRNA-1018-H5, and to evaluate the safety and reactogenicity of mRNA-1018-H5 in adults ≥18 years of age.",[178],"Influenza",[180,118,181,182,122,183,184,185,186],"Influenza Vaccine","mRNA-1018-H5","Viral Diseases","Pandemic Influenza","Avian Flu","Bird Flu","Influenza A","2026-04-02",{"date":189,"type":37},"2026-04-03",{"date":191,"type":37},"2026-03-23",{"date":193,"type":20},"2027-01-28",{"name":43,"class":44},36,{"id":197,"slug":198,"hasResults":11,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":4,"eligibilityCriteria":202,"healthyVolunteers":109,"sex":16,"minAge":203,"maxAge":4,"enrollmentInfo":204,"targetDuration":4,"studyType":21,"phases":206,"briefSummary":207,"conditions":208,"keywords":209,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":215,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":222},"100561060","phase-4-a-study-to-investigate-the-immunogenicity-and-safety-of-mrna-covid-19-variant-containing-vaccine-formulations-100561060","NCT06585241","A Study to Investigate the Immunogenicity and Safety of mRNA COVID-19 Variant-containing Vaccine Formulations","A Phase 3b\u002F4, Open-label Study to Assess the Immunogenicity and Safety of mRNA COVID-19 Variant-containing Vaccine Formulations","Key Inclusion Criteria:\n\n* mRNA-1273.167 and mRNA-1273.712: Previously vaccinated adults aged ≥18 years\n* mRNA-1273.251: Participants ≥65 years of age, ≥12 to \\\u003C65 years of age, or ≥6 months to \\\u003C12 years of age with at least 1 risk factor for severe outcomes from COVID-19.\n* mRNA-1273.261: ≥65 years of age at the time of signing the informed consent or ≥18 to \\\u003C65 years of age at the time of signing the informed consent with at least 1 risk factor for severe outcomes from COVID-19.\n* Able to comply with study procedures based on the assessment of the Investigator.\n* Female participants of childbearing potential may be enrolled in the study if the participant fulfills all the following criteria:\n\n  * Has a negative pregnancy test at the Screening Visit and on the day of vaccination prior to vaccine dose being administered on Day 1.\n  * Has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first dose.\n  * Has agreed to continue adequate contraception through 28 days following vaccine administration.\n\nKey Exclusion Criteria:\n\n* History of SARS-CoV-2 infection within 3 months prior to enrollment for mRNA-1273.167 and mRNA-1273.712 or within up to 6 months prior to enrollment for mRNA-1273.251 and mRNA-1273.261.\n* Is acutely ill or febrile (temperature 38.0°Celsius\u002F100.4°Fahrenheit) less than 72 hours prior to or at the Screening Visit or Day 1. Participants meeting this criterion may be rescheduled within the Screening window.\n* History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable, or may affect participant safety, assessment of study endpoints, assessment of immune response, or adherence to study procedures.\n* History of anaphylaxis or severe hypersensitivity reaction requiring medical intervention after receipt of any mRNA vaccine or therapeutic or any components of an mRNA vaccine or therapeutic.\n* Receipt of COVID-19 vaccine within 3 months prior to enrollment for mRNA-1273.167 and mRNA-1273.712 or within 6 months prior to enrollment for mRNA-1273.251 and mRNA-1273.261.\n* Receipt of any licensed non-COVID-19 vaccine within 14 days (inactivated vaccine, pediatric) or 28 days before or planned receipt within 14 days (pediatric) or 28 days after the study intervention, except an influenza vaccine, which may be given at least 7 days before (pediatric) or 14 days before or after receipt of the study intervention.\n* Receipt of systemic immunosuppressants or immune-modifying drugs for \\>14 days total (within 6 months prior to Screening for mRNA-1273.167 and mRNA-1273.712 or within 180 days prior to Screening for mRNA-1273.251 and mRNA-1273.261) or is anticipating the need for immunosuppressive treatment at any time during participation in the study.\n* Receipt of systemic immunoglobulins, long-acting biological therapies that affect immune (pediatric) responses, or blood products (within 3 months prior to Screening for mRNA-1273.167 and mRNA-1273.712 or within 90 days prior to the Screening for mRNA-1273.251 and mRNA-1273.261) or plans for receipt during the study.\n* Has donated ≥450 milliliters of blood products within 28 days prior to the Screening Visit or plans to donate blood products during the study.\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","6 Months",{"count":205,"type":20},1144,[142],"The purpose of this study is to investigate the immunogenicity and safety of mRNA COVID-19 variant-containing vaccine formulations against the vaccine-matched variants and newly emerged variants of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).",[149],[210,211,149,150,151,153,120,145,212,213,118,214],"mRNA-1273","mRNA-1273 vaccine","COVID-19 Vaccine","Variant","Pediatric",{"date":216,"type":37},"2026-03-27",{"date":218,"type":37},"2024-09-09",{"date":220,"type":20},"2026-12-31",{"name":43,"class":44},6,{"id":224,"slug":225,"hasResults":11,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":4,"eligibilityCriteria":229,"healthyVolunteers":109,"sex":16,"minAge":17,"maxAge":230,"enrollmentInfo":231,"targetDuration":4,"studyType":21,"phases":233,"briefSummary":234,"conditions":235,"keywords":237,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":247},"100629767","phase-1-a-study-of-an-epstein-barr-virus-ebv-candidate-vaccine-mrna-1189-in-healthy-adults-18-to-30-years-of-age-100629767","NCT07478952","A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1189 in Healthy Adults 18 to 30 Years of Age","A Phase 1, Randomized, Open-label Study to Evaluate Safety, Reactogenicity, and Immunogenicity of an Epstein-Barr Virus Candidate Vaccine, mRNA-1189, Following Intradermal and Intramuscular Delivery in Healthy Adults 18 to 30 Years of Age","Inclusion Criteria:\n\n* Healthy as determined by medical evaluation including medical history and physical examination.\n* Participants who are assigned female at birth or could become pregnant are eligible to participate if the participant is not pregnant or breast\u002Fchest feeding.\n\nExclusion Criteria:\n\n* Have undergone surgical procedures within 7 days prior to Day 1 or Day 57 or are scheduled to undergo a surgical procedure within 28 days after study intervention administration.\n* Reported history of congenital or acquired immunodeficiency, immunosuppressive condition, asplenia, or recurrent severe infectious disease.\n* Received corticosteroids at ≥10 milligrams per day (mg\u002Fday) of prednisone or equivalent for \\>14 days in total within 90 days prior to Day 1 or is anticipating the need for corticosteroids at any time during the study.\n* Received systemic immunosuppressive treatment, including long-acting biological therapies that affect immune responses, within 180 days prior to Day 1 or plans to do so during the study.\n* Received or plans to receive any nonstudy vaccine from 28 days prior to first dose\u002FDay 1 up to 28 days after the second dose\u002FDay 57.\n* History of myocarditis, pericarditis, or myopericarditis prior to Day 1.\n* Has previously received an investigational EBV vaccine.\n\nNote: Other inclusion and exclusion criteria may apply.","30 Years",{"count":232,"type":20},120,[23],"The main objective of this trial is to evaluate the safety and immunogenicity of mRNA-1189 after intradermal and intramuscular delivery.",[236],"Epstein-Barr Virus",[238],"Epstein-Barr Virus (EBV)","2026-03-20",{"date":241,"type":37},"2026-03-24",{"date":243,"type":37},"2026-03-17",{"date":245,"type":20},"2027-05-15",{"name":43,"class":44},2,{"id":249,"slug":250,"hasResults":11,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":4,"eligibilityCriteria":254,"healthyVolunteers":11,"sex":16,"minAge":255,"maxAge":4,"enrollmentInfo":256,"targetDuration":4,"studyType":21,"phases":258,"briefSummary":259,"conditions":260,"keywords":262,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":273,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":279},"100449281","phase-1-a-study-to-assess-the-long-term-safety-and-clinical-activity-of-mrna-3927-in-participants-previously-enrolled-in-the-mrna-3927-p101-study-100449281","NCT05130437","A Study to Assess the Long-term Safety and Clinical Activity of mRNA-3927 in Participants Previously Enrolled in the mRNA-3927-P101 Study","A Phase 1\u002F2, Global, Open-Label, Extension Study to Evaluate the Long-Term Safety and Clinical Activity of mRNA-3927 in Participants Previously Enrolled in the mRNA-3927-P101 Study","Inclusion Criteria:\n\n* Participated in Study mRNA-3927-P101.\n* Completed the EOT\u002FET visit in Study mRNA-3927-P101 and enroll in this study such that the first dose in this study is planned to be within 14±3 days of the last dose of mRNA-3927 in the mRNA-3927-P101 study.\n\nExclusion Criteria:\n\n* Not expected to receive clinical benefit from continued mRNA-3927 administration, in the opinion of the Investigator.\n* Any clinical or laboratory abnormality or medical condition that, at the discretion of the Investigator, may put the individual at increased risk by participating in this study.\n* History of liver and\u002For kidney transplant.","1 Year",{"count":257,"type":20},50,[23,24],"The main purpose of this study is to evaluate the long-term safety of mRNA-3927 administered to participants with propionic acidemia (PA) who have previously participated in Study mRNA-3927-P101 (NCT04159103).",[261],"Propionic Acidemia",[263,264,265,266,267,268,269,270,271,118,272],"mRNA-3927","Propionic Aciduria","Metabolism, Inborn Errors","Genetic Diseases","Inborn Amino Acid Metabolism, Inborn Errors","Acidosis","Acid-Base Imbalance","Metabolic Diseases","Organic Acidemias","mRNA",{"date":191,"type":37},{"date":275,"type":37},"2021-11-09",{"date":277,"type":20},"2031-12-04",{"name":43,"class":44},22,{"id":281,"slug":282,"hasResults":11,"nctId":283,"briefTitle":284,"officialTitle":285,"acronym":4,"eligibilityCriteria":286,"healthyVolunteers":11,"sex":16,"minAge":287,"maxAge":4,"enrollmentInfo":288,"targetDuration":4,"studyType":290,"phases":4,"briefSummary":291,"conditions":292,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":293,"lastUpdatePostDateStruct":294,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":301},"100498389","a-retrospective-study-to-characterize-participants-with-propionic-acidemia-100498389","NCT05769621","A Retrospective Study to Characterize Participants With Propionic Acidemia","A Retrospective Cohort Study to Characterize Propionic Acidemia Patients","Inclusion Criteria:\n\nParticipants' medical records are eligible for abstraction only if all of the following criteria apply:\n\n* Confirmed diagnosis of PA based on diagnosis by molecular genetic testing (propionyl-CoA carboxylase subunitα\\[PCCA\\] and\u002For propionyl-CoA carboxylase subunitβ\\[PCCB\\] mutations).\n* Participant provided informed consent (and assent, as applicable).\n* Medical records with sufficient data to support medical encounter for CEC adjudication (MEA adjudication) must be available dating back to birth or 01 January 2015, whichever occurs later. Participants born prior to 2015 will require additional information to confirm eligibility.\n* Experienced at least one MDE in the 24 months preceding the Index Date or experienced at least 3 MDEs within any one 12-month retrospective review period (based on Index Date) dating back to birth or 01 January 2015, whichever occurs later.\n* Must have a confirmed age (months) of disease onset (early or late, where early is defined as the neonatal period).\n* Participants who meet any of the censoring criteria listed below may be enrolled into the study if they have a minimum of 2 years of data available for abstraction prior to meeting the censoring criteria and they meet all inclusion criteria based on the data available for abstraction.\n\nCensoring Criteria:\n\nParticipants medical records meeting the following censoring criterion will not be abstracted:\n\n* Participation in a clinical study of any investigational agent.\n* Received gene therapy treatment\n* Confirmed organ transplantation\n* Investigator is no longer able to obtain relevant clinical information of the participant.\n* Death\n\nExclusion Criteria:\n\nParticipant's medical records will not be eligible for abstraction if the participant meets the following exclusion criteria:\n\n\\- Participation (prior or ongoing) in clinical study mRNA-3927-P101 (NCT04159103) or mRNA-3927-P101-EXT (NCT05130437).","2 Years",{"count":289,"type":20},60,"OBSERVATIONAL","This is a non-interventional, observational, global, multicenter, study describing participant characteristics, clinical outcomes, and event rates in participants with propionic acidemia (PA).",[261],"2026-02-03",{"date":295,"type":37},"2026-02-05",{"date":297,"type":37},"2023-06-16",{"date":299,"type":20},"2026-09-30",{"name":43,"class":44},29,{"id":303,"slug":304,"hasResults":11,"nctId":305,"briefTitle":306,"officialTitle":307,"acronym":4,"eligibilityCriteria":308,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":309,"targetDuration":4,"studyType":21,"phases":311,"briefSummary":312,"conditions":313,"keywords":314,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":322,"locationsCount":323},"100374718","phase-1-open-label-study-of-mrna-3927-in-participants-with-propionic-acidemia-100374718","NCT04159103","Open-Label Study of mRNA-3927 in Participants With Propionic Acidemia","A Global, Phase 1\u002F2, Open-Label, Dose Optimization Study to Evaluate the Safety, Pharmacodynamics, and Pharmacokinetics of mRNA-3927 in Participants With Propionic Acidemia","Inclusion Criteria:\n\nParticipants ≥1 year of age are eligible to be included in the study only if all of the following criteria apply:\n\n* ≥ 8 years of age at the time of consent\u002Fassent if enrolled as 1 of the first 2 participants in Part 1.\n* ≥1 year of age at the time of consent\u002Fassent if enrolled after the first 2 participants in Part 1.\n* Confirmed diagnosis of PA based on diagnosis by molecular genetic testing via central laboratory (PCCA and\u002For PCCB mutations).\n* Part 2 only: At least one documented MDE in the 12-month period before consent.\n\nParticipants \\\u003C1 Year of Age :\n\n* Identification by newborn screening shortly after birth or having suspected PA by presenting with a spectrum of metabolic symptoms, and having a sibling diagnosed with PA. Participant may enter the Screening Period while awaiting genetic testing results, provided that all other eligibility criteria are met but would not be enrolled until diagnosis of PA is confirmed.\n* For infants in the neonatal intensive care unit (NICU) only: ≥37 weeks gestational age at the time of birth without other conditions\u002Fcomorbidities that in the opinion of the Investigator may interfere with the interpretation of study results.\n* Body weight ≥3 kilograms (kg) at Screening.\n* At least 1 documented PA-related event prior to Screening defined as the following criteria:\n\n  * Clinical signs of metabolic deterioration consistent with PA (for example, vomiting, not feeding well\u002Fpoor suck, heavy breathing, lethargy, absence of proper perfusion, abnormal movements including bicycling, abnormal tone, low body temperature, seizure\\[s\\]), OR\n  * Meeting the criteria of MDE definition, OR\n  * Evidence of laboratory abnormalities as evidenced by at least one of the following:\n* Metabolic acidosis with elevated anion gap.\n* Acute hyperammonemia.\n* Neutropenia or thrombocytopenia.\n\nExclusion Criteria:\n\nParticipants of all ages are excluded from the study if during Screening any of the following criteria apply:\n\n* Any individual with laboratory abnormalities considered to be clinically significant (for example, markedly out of range, associated with clinical symptoms) in the Investigator or Sponsor's opinion that could interfere with or limit the participation in the study.\n* Estimated glomerular filtration rate (eGFR) \\\u003C30 milliliters (mL)\u002Fminute\u002F1.73 square meter (m\\^2) for participants of all ages receiving chronic dialysis.\n* History of organ transplantation or planned organ transplantation during the period of study participation.\n* Corrected QT interval (QTc) \\>480 milliseconds (ms) using Bazett's correction.\n* Grade 3 or 4 heart failure according to the Modified Ross Heart Failure Classification for Children or the New York Heart Association Classification.\n* Pregnant or breastfeeding.\n* Other clinically significant conditions that in the Investigator's opinion could interfere with the safety of the participant, the interpretation of study results, or limit the participation in the study.",{"count":310,"type":20},77,[23,24],"This 3-part, Phase 1\u002F2 study is designed to characterize the safety, tolerability, and pharmacological activity (as assessed by biomarker measurements) and to determine the selected dose of mRNA-3927 in participants with genetically confirmed propionic acidemia (PA). After establishing a dose with an acceptable safety and pharmacodynamic (PD) response for participants ≥1 year of age in Part 1, participants will be enrolled in Part 2 (which will serve as the pivotal study) to allow for determination of the efficacy, safety, and PD of mRNA-3927. Part 3 will evaluate the safety, efficacy and PD response of mRNA-3927 in infants (\\\u003C1 year of age).",[261],[263,264,265,266,267,268,269,270,271,118,272],"2026-01-20",{"date":317,"type":37},"2026-01-22",{"date":319,"type":37},"2021-04-15",{"date":321,"type":20},"2027-08-31",{"name":43,"class":44},35,{"id":325,"slug":326,"hasResults":11,"nctId":327,"briefTitle":328,"officialTitle":329,"acronym":4,"eligibilityCriteria":330,"healthyVolunteers":11,"sex":16,"minAge":255,"maxAge":4,"enrollmentInfo":331,"targetDuration":4,"studyType":21,"phases":333,"briefSummary":334,"conditions":335,"keywords":337,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":343,"startDateStruct":345,"completionDateStruct":347,"leadSponsor":349,"locationsCount":5},"100461959","phase-1-an-extension-study-to-evaluate-the-long-term-safety-and-clinical-activity-of-mrna-3705-in-participants-previously-enrolled-in-other-clinical-studies-of-mrna-3705-100461959","NCT05295433","An Extension Study to Evaluate the Long-Term Safety and Clinical Activity of mRNA-3705 in Participants Previously Enrolled in Other Clinical Studies of mRNA-3705","A Phase 1\u002F2, Global, Open-Label, Extension Study to Evaluate the Long-Term Safety and Clinical Activity of mRNA-3705 in Participants Previously Enrolled in Other Clinical Studies of mRNA-3705","Inclusion Criteria:\n\n* Completed the assigned dose regimen treatment time period in other clinical studies of mRNA-3705 or is eligible for early transition to this study because they missed more than 3 consecutive doses of study drug due to coronavirus disease 2019 (COVID-19) vaccination during Study mRNA-3705-P101 Part 1.\n* Completed the End of treatment (EOT) Visit (or End of Study Visit in the case of unscheduled dosing) in Study mRNA-3705-P101 within 10 days of their first dose of mRNA-3705 in this extension study.\n\nExclusion Criteria:\n\n* Not expected to receive clinical benefit from continued mRNA-3705 administration, in the opinion of the Investigator.\n* Any clinical or laboratory abnormality or medical condition that, at the discretion of the Investigator, may put the individual at increased risk by participating in this study.\n* History of liver and\u002For kidney transplant.\n\nNOTE: Other inclusion and exclusion criteria may apply.",{"count":332,"type":20},56,[23,24],"The primary objective of this study is to evaluate the long-term safety and clinical activity of mRNA-3705 administered to participants with isolated methylmalonic acidemia (MMA) due to methylmalonyl-coenzyme A mutase (MUT) deficiency who have previously participated in other clinical studies of mRNA-3705.",[336],"Methylmalonic Acidemia",[338,339,340,265,266,118,272,341],"Isolated Methylmalonic acidemia","Isolated methylmalonic aciduria","Elevated methylmalonic acid (MMA)","mRNA-3705","2025-12-22",{"date":344,"type":37},"2025-12-23",{"date":346,"type":37},"2022-03-08",{"date":348,"type":20},"2034-04-02",{"name":43,"class":44},""]