[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100478695":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":10,"centralContacts":10,"locations":10,"responsibleParty":28,"collaborators":32,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":43,"eligibilityCriteria":44,"healthyVolunteers":45,"sex":46,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":10,"studyType":52,"phases":10,"briefSummary":53,"conditions":54,"keywords":57,"overallStatus":61,"whyStopped":10,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":10},{"fullName":5,"class":6},"Womack Army Medical Center","FED",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Jynneos vaccine with out other vaccines",null,"Allocated to Jynneos without any need for additional indicated\u002Frequired vaccines intervention. JYNNEOS (Smallpox and Monkeypox Vaccine, Live, Nonreplicating) suspension for subcutaneous injection. Administer two doses (0.5 mL each) 4 weeks apart. Each dose (0.5 mL) is supplied in a singledose vial.",[13],"Biological: JYNNEOS",{"label":15,"type":10,"description":16,"interventionNames":17},"Jynneos vaccine with other vaccines at dose 1","Allocated to Jynneos with concomitant vaccines given at time of first dose of Jynneos intervention.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Jynneos vaccine with other vaccines at dose 2","Allocated to Jynneos with concomitant vaccines given at time of second dose of Jynneos.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":10},"BIOLOGICAL","JYNNEOS","smallpox vaccine",[15,19,9],{"type":29,"investigatorFullName":30,"investigatorTitle":31,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Laurie Housel","MSN, FNP-C",[33,35],{"name":34,"class":6},"United States Naval Medical Center, San Diego",{"name":36,"class":6},"C.R.Darnall Army Medical Center","100478695","assessment-of-myocarditis-after-replication-deficient-smallpox-immunization-100478695",false,"NCT05513313","Assessment of Myocarditis After Replication-Deficient Smallpox Immunization","Prospective Assessment of Myocarditis After Replication-Deficient Smallpox Immunization","PAMARDSI","Inclusion Criteria:\n\n* Active duty military personnel within the range of 18-45 years of age without limitations to gender or ethnicity.\n* Primary vaccinee (receiving smallpox vaccine for the first time) with a force health protection requirement for the smallpox vaccination\n* Medical screening for immunization completed and potential participant found eligible for immunization (standard of care)\n\nExclusion Criteria:\n\n* Known contraindication to replication deficient smallpox vaccination based on FDA-approved package insert for JYNNEOS™ vaccine.\n* No indication for replication deficient smallpox vaccination based on FDA-approved package insert for JYNNEOS, ACIP or DoD guidelines\n* Secondary smallpox vaccinee (patients who had previously received any smallpox vaccine).\n* Age less than 18 years or age greater than 45 years.\n* Inability to provide informed consent.\n* Presence of a moderate or severe acute illness with or without a fever\n* Pregnancy: We will rely on the subject for an assessment of her pregnancy status, based on answers in the routine adult immunization screening questionnaire. (Screening by history is the current standard of care.)\n* Scheduled deployment, PCS or TDY that would interfere with the respective follow-up visits. (no planned deployment, TDY or PCS for 65 days after enrollment\u002Fvisit 1).",true,"ALL","18 Years","45 Years",{"count":50,"type":51},2350,"ESTIMATED","OBSERVATIONAL","This is a prospective observational phase IV study of a novel, replication-deficient smallpox vaccine that has been recently been approved by FDA. The purpose of this study is to determine if there are any abnormalities detected by electrocardiographic testing and\u002For blood tests within 35 days of receiving the second dose of smallpox vaccine either alone or co-administered with other vaccines that may\u002Fmay not be suggestive of myopericarditis.",[55,56],"Myopericarditis","Small Pox",[58,59,60],"Small pox vaccine","ACAM2000™","Dryvax®","NOT_YET_RECRUITING","2023-12-07",{"date":64,"type":65},"2023-12-14","ACTUAL",{"date":67,"type":51},"2029-03",{"date":69,"type":51},"2033-10",{"name":5,"class":6}]