[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572558":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":39,"responsibleParty":93,"collaborators":26,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":26,"eligibilityCriteria":101,"healthyVolunteers":102,"sex":103,"minAge":104,"maxAge":105,"enrollmentInfo":106,"targetDuration":26,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":115,"overallStatus":42,"whyStopped":26,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"Sinovac Biotech Co., Ltd","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"trial group","EXPERIMENTAL","Bivalent enterovirus inactivated vaccine (Vero cell)",[13],"Biological: bivalent enterovirus vaccine (Vero cell), inactivated",{"label":15,"type":16,"description":17,"interventionNames":18},"control group","ACTIVE_COMPARATOR","Enterovirus Type 71 Vaccine (Vero Cell), Inactivated",[19],"Biological: Enterovirus Type 71 Vaccine (Vero Cell), Inactivated",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BIOLOGICAL","bivalent enterovirus vaccine (Vero cell), inactivated","Two doses are administered with a one-month interval between each dose.",[9],null,{"type":22,"name":17,"description":24,"armGroupLabels":28,"otherNames":26},[15],[30],{"name":31,"affiliation":32,"role":33},"Liu Xiaoqiang, Dr.","Yunnan Provincial Center for Disease Control and Prevention","PRINCIPAL_INVESTIGATOR",[35],{"name":31,"role":36,"phone":37,"phoneExt":26,"email":38},"CONTACT","98-15911568282","lxq7611@126.com",[40,57,69,82],{"facility":41,"status":42,"city":43,"state":44,"zip":26,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Anhui Provincial Center for Disease Control and Prevention","RECRUITING","Hefei","Anhui","China","CN",{"type":48,"coordinates":49},"Point",[50,51],117.28083,31.86389,{"lat":51,"lon":50},[54],{"name":55,"role":36,"phone":56,"phoneExt":26,"email":26},"Tang Jihai","15395002840",{"facility":58,"status":42,"city":59,"state":26,"zip":26,"country":45,"countryCode":46,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"Fujian Provincial Center for Disease Control and Prevention","Fujian",{"type":48,"coordinates":61},[62,63],106.12972,28.92651,{"lat":63,"lon":62},[66],{"name":67,"role":36,"phone":68,"phoneExt":26,"email":26},"Zhang Dongjuan","13799327516",{"facility":70,"status":42,"city":71,"state":26,"zip":72,"country":45,"countryCode":46,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Guangdong Provincial Center for Disease Control and Prevention","Guangdong","650000",{"type":48,"coordinates":74},[75,76],129.33635,42.76832,{"lat":76,"lon":75},[79],{"name":80,"role":36,"phone":81,"phoneExt":26,"email":26},"Huang Zhuhang","13602438596",{"facility":83,"status":42,"city":84,"state":26,"zip":26,"country":45,"countryCode":46,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Hubei Provincial Center for Disease Control and Prevention","Hubei",{"type":48,"coordinates":86},[87,88],120.41732,29.08114,{"lat":88,"lon":87},[91],{"name":92,"role":36,"phone":26,"phoneExt":26,"email":26},"Tong Yeqing",{"type":94,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100572558","phase-3-efficacy-safety-and-immunogenicity-of-the-bivalent-inactivated-enterovirus-vaccine-vero-cell-100572558",false,"NCT06734832","Efficacy, Safety, and Immunogenicity of the Bivalent Inactivated Enterovirus Vaccine (Vero Cell)","A Multicenter, Randomized, Double-blind, Controlled Phase III Clinical Trial on the Efficacy, Safety, and Immunogenicity of the Bivalent Enterovirus Inactivated Vaccine (Vero Cell) in Children Aged 6 to 71 Months.","Inclusion Criteria:\n\n* Healthy children aged 6 to 71 months with no history of EV71 vaccination; or healthy children aged 24 to 71 months who have completed two doses of EV71 vaccine at least 6 months prior.\n* Guardians who can understand and voluntarily sign the informed consent form.\n* Willing and able to comply with all visit schedules, sample collections, vaccinations, and other research procedures.\n* Provide proof of identity documents.\n\nExclusion Criteria:\n\n* A known history of HFMD\u002FHA.\n* Uncontrolled chronic diseases or a history of severe illnesses, including but not limited to cardiovascular diseases, blood disorders, liver or kidney diseases, digestive system diseases, respiratory system diseases, malignant tumors, or a history of major functional organ transplantation.\n* Autoimmune diseases, immunodeficiency diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid diseases, asplenia, functional asplenia, and HIV infection).\n* Abnormal coagulation function (such as coagulation factor deficiencies, and platelet abnormalities).\n* Suffering from\u002Fhaving a history of severe neurological diseases (epilepsy, convulsions, or seizures \\[excluding a history of febrile seizures\\]) psychiatric disorders, or a family history of psychiatric disorders.\n* Various acute diseases or exacerbations of chronic diseases within the last 3 days, or known or suspected active infections.\n* Received a vaccine containing CA16 components.\n* Received immunosuppressive or other immunomodulatory treatments for ≥14 days within the past 6 months (prednisone ≥2mg\u002Fkg\u002Fday, or its equivalent; local or inhaled corticosteroids excluded), cytotoxic therapy, or planning to receive such treatment during the trial.\n* Received immunoglobulin or other blood products within the past 6 months, or planning to receive such treatment during the trial.\n* Received other investigational drugs or vaccines within the past 30 days, or planning to receive such drugs or vaccines during the trial.\n* Received live attenuated vaccines or nucleic acid vaccines within the past 14 days, or subunit or inactivated vaccines within the past 7 days.\n* Known allergy to any component of the investigational vaccine (inactivated EV71 virus, inactivated CA16 virus, aluminum hydroxide, sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate, injectable water).\n* On the day of the planned vaccination with the trial vaccine, there is a fever, with axillary temperature \\> 37.0°C before vaccination;\n* On the day of the planned vaccination with the trial vaccine, the physical examination is not qualified.\n* Skin damage, inflammation, ulcers, rash, or scars at the target injection site that may interfere with vaccination or observation of local reactions.\n* According to the investigator's judgment, participants have any other factors that make them unsuitable for participation in the clinical trial.",true,"ALL","6 Months","71 Months",{"count":107,"type":108},8000,"ESTIMATED","INTERVENTIONAL",[111],"PHASE3","This multicenter, randomized, double-blind, controlled Phase III clinical trial aims to evaluate the efficacy, safety, and immunogenicity of the bivalent enterovirus-inactivated vaccine (Vero cell) in healthy children aged 6 to 71 months.\n\nThe main questions it aims to answer are:\n\n* The primary vaccine efficacy of the investigational vaccine against Hand, Foot, and Mouth Disease（HFMD) caused by CA16 infection compared to the control vaccine.\n* The neutralizing antibody levels against EV71 in the trial group are non-inferior to those in the control group after two doses of vaccination.\n\nResearchers will compare the bivalent enterovirus-inactivated vaccine (Vero cell) to the EV71-inactivated vaccine (Vero cell) to prevent HFMD and Herpangina(HA).\n\nParticipants will be randomly assigned to the trial group and the control group in a 1:1 ratio to receive two doses of the investigational vaccine or the control EV71 vaccine, with a one-month interval between doses.",[114],"Hand, Foot, and Mouth Disease（HFMD)",[116,117,118,119,120,121,122,123],"bivalent enterovirus inactivated vaccine","Hand, Foot, and Mouth Disease","EV71","CA16","PHASE Ⅲ","vaccine efficacy","immonogenicity","safety","2024-12-31",{"date":126,"type":127},"2025-01-01","ACTUAL",{"date":129,"type":127},"2024-12-13",{"date":131,"type":108},"2026-11-30",{"name":5,"class":6},4]