[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Sanofi Pasteur, a Sanofi Company\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":107},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,42,67,87],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100540396","phase-1-study-to-evaluate-safety-efficacy-and-immunogenicity-of-acne-mrna-vaccine-in-adults-with-moderate-to-severe-acne-100540396",false,"NCT06316297","Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Adults With Moderate to Severe Acne","A Phase I\u002FII, Randomized, Placebo-controlled, Multi-arm, Dose-finding Study to Evaluate the Safety, Efficacy and Immunogenicity of an Acne mRNA Vaccine Candidate in Adults With Moderate to Severe Acne 18 to 45 Years of Age","Inclusion Criteria:\n\n* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests as judged by the investigator\n* Clinical diagnosis of moderate or severe facial acne vulgaris with Investigator's Global Assessment (IGA) score of Moderate or Severe (grade 3 or grade 4 on the 5-grade IGA scale) and ≥ 25 non-inflammatory lesions (ie, open and closed comedones) and ≥ 20 inflammatory lesions (ie, papules and pustules) and ≤ 2 nodulocystic lesions (ie, nodules and cysts)\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within 6 months prior to the first study intervention administration; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)\n* Known systemic hypersensitivity to any of the study intervention components; history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances; any allergic reaction (eg, anaphylaxis) after administration of mRNA coronavirus disease 2019 (COVID-19) vaccine\n* Active nodulocystic acne, acne conglobate, acne fulminans, secondary acne (eg, chloracne, drug-induced acne) or other forms of acne (eg, acne mechanica)\n* Use of any acne-affecting treatment without an appropriate washout period\n* Receipt of any vaccine (other than the study vaccine) in the 4 weeks preceding any study intervention administration or planned receipt of any vaccine (other than the study vaccine) in the 4 weeks following any study intervention administration\n* Previous vaccination against C. acnes with an investigational vaccine\n* Receipt of immune globulins, blood or blood-derived products in the past 3 months\n* Self-reported or documented seropositivity for human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus.\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.","ALL","18 Years","45 Years",{"count":20,"type":21},800,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","The purpose of the trial is to evaluate the safety, efficacy and immunogenicity of up to 3 intramuscular injections of the Acne mRNA vaccine candidate at up to four dose levels in adult participants aged 18 to 45 years with moderate to severe acne.\n\nThis trial will consist of a Core Study followed by an optional Long-Term Extension (LTE).\n\nThe Core Study will consist of:\n\n* Two cohorts evaluating the 2-administration regimen (Cohorts A): Sentinel Cohort A and Main Cohort A.\n* Two cohorts evaluating the 3-administration regimen (Cohorts B): Sentinel Cohort B and Main Cohort B.\n\nParticipants from Sentinel Cohorts A and B and from Main Cohort A will be invited to an additional 30-month follow up after completing their last planned Core Study visit to assess the long-term effects of the vaccine. Participants from Main Cohort B will be invited to another LTE study managed through a separate protocol.",[28],"Acne","RECRUITING","2026-04-30",{"date":32,"type":33},"2026-05-05","ACTUAL",{"date":35,"type":33},"2024-04-05",{"date":37,"type":21},"2028-11-30",{"name":39,"class":40},"Sanofi Pasteur, a Sanofi Company","INDUSTRY",93,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":51,"targetDuration":53,"studyType":54,"phases":4,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100399854","dengvaxia-us-pregnancy-registry-100399854","NCT04486638","Dengvaxia US Pregnancy Registry","Dengvaxia US Pregnancy Registry: A Surveillance Study to Assess the Safety of Dengvaxia Among Exposed Pregnant Women and Their Offsprings (DNG00044)","DNG00044","The eligible population will include pregnant women of any age and their offspring(s) residing in the US and its Territories whose Dengvaxia pregnancy exposure is reported to the pregnancy registry.\n\nReports of Dengvaxia pregnancy exposure must contain the following information to be included in the registry:\n\n* Sufficient evidence to confirm the case qualifies as \"exposed during pregnancy\";\n* Vaccine name (brand or generic) is provided (i.e., including manufacturer unknown exposures).\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.",true,{"count":52,"type":21},500,"22 Months","OBSERVATIONAL","The primary objective of this study is to assess maternal, obstetrical, pregnancy, and neonatal and infant outcomes among women and their offspring(s) vaccinated with Dengvaxia during their pregnancy",[57],"Dengue Virus Infection","2026-01-19",{"date":60,"type":33},"2026-01-21",{"date":62,"type":33},"2023-01-01",{"date":64,"type":21},"2029-06-30",{"name":39,"class":40},1,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":50,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":74,"targetDuration":53,"studyType":54,"phases":4,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":66},"100427215","observational-passive-surveillance-program-to-collect-information-on-women-and-their-offspring-exposed-to-menquadfi-during-pregnancy-in-united-states-us-100427215","NCT04843111","Observational, Passive Surveillance Program to Collect Information on Women and Their Offspring Exposed to MenQuadfi® During Pregnancy, in United States (US)","The MenQuadfi® Pregnancy Registry: A Surveillance Registry to Assess the Safety of MenQuadfi® Among Exposed Pregnant Women and Their Offspring","Inclusion Criteria:\n\nThe eligible population will include pregnant women and their offspring residing in the US and its territories who are exposed to MenQuadfi® during their pregnancy or within 30 days prior to their LMP, for whom the exposure is reported to the pregnancy registry.\n\nReports of MenQuadfi® pregnancy exposure must contain the following information:\n\n* Sufficient evidence to confirm that vaccination occurred during the pregnancy or in the 30 days preceding the LMP;\n* Vaccine name (brand or generic) is provided (i.e., MenQuadfi®, Meningococcal vaccine, MenACWY conjugate vaccine), or not specified (eg, meningococcal vaccine from an unknown manufacturer).\n\nExclusion Criteria:\n\nOnly post-marketing spontaneous case reports will be included; reports from clinical trials will not be part of the registry.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.",{"count":75,"type":21},50,"Primary Objective:\n\nTo assess maternal, obstetrical, pregnancy, and neonatal and infant outcomes among women vaccinated with MenQuadfi® during pregnancy or in the 30 days preceding their Last Menstrual Period (LMP).",[78],"Meningococcal Infection","2025-11-27",{"date":81,"type":33},"2025-12-01",{"date":83,"type":33},"2021-03-05",{"date":85,"type":21},"2028-05-18",{"name":39,"class":40},{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":94,"targetDuration":4,"studyType":22,"phases":96,"briefSummary":97,"conditions":98,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":5},"100594000","phase-1-study-to-evaluate-safety-efficacy-and-immunogenicity-of-acne-mrna-vaccine-in-participants-with-mild-acne-100594000","NCT07013747","Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Participants With Mild Acne","A Phase 1\u002F2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Efficacy and Immunogenicity of an Acne mRNA Vaccine Candidate in Participants With Mild Acne","Inclusion Criteria:\n\n* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests as judged by the investigator\n* Clinical diagnosis of mild facial acne vulgaris with:\n\n  * IGA score of mild (grade 2 on the 5-grade IGA scale) AND\n  * between 10 to 24 non-inflammatory lesions (ie, open and closed comedones) AND\n  * between 5 to 19 inflammatory lesions (ie, papules and pustules) AND\n  * no nodulocystic lesions (ie, nodules and cysts)\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within 6 months prior to the first study intervention administration; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)\n* Known systemic hypersensitivity to any of the study intervention components (eg, polyethylene glycol \\[PEG\\], polysorbate); history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances; any allergic reaction (eg, anaphylaxis) after administration of mRNA coronavirus disease 2019 (COVID 19) vaccine\n* Previous history of myocarditis and\u002For pericarditis and\u002For myopericarditis\n* Skin pathology or condition that, in the investigator's opinion, could interfere with the evaluation of the study intervention or requires use of interfering topical, systemic, or surgical therapy\n* Excessive facial hair, facial tattoos, facial skin disorders, skin reactions that may interfere with the study assessments in the investigator's opinion (including - but not limited to - actinic keratosis, eczema, psoriasis, seborrheic dermatitis, rosacea, acute or recent sunburn) or skin infection\n* Receipt of immune globulins, blood or blood-derived products in the past 3 months\n* Self-reported or documented seropositivity for human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus",{"count":95,"type":21},120,[24,25],"The purpose of the VBE00009 study is to evaluate the safety, efficacy and immunogenicity of 2 administrations of the Acne mRNA vaccine candidate at single dose level in participants aged 18 to 45 years with mild acne. This study will consist of a Core Study followed by an optional Long-Term Extension (LTE). Core Study will include a Sentinel Cohort and a Main Cohort, with the Sentinel Cohort assessing the safety in a stepwise manner. If the participants consent to the LTE, they will be followed up for an additional 30 months after the last planned visit in the Core Study, to assess the long term effects of the vaccine.",[28],"2025-08-28",{"date":101,"type":33},"2025-09-05",{"date":103,"type":33},"2025-07-03",{"date":105,"type":21},"2029-06-19",{"name":39,"class":40},""]