[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572558":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":39,"responsibleParty":92,"collaborators":26,"id":94,"slug":26,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":26,"eligibilityCriteria":99,"healthyVolunteers":100,"sex":101,"minAge":102,"maxAge":103,"enrollmentInfo":104,"targetDuration":26,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":42,"whyStopped":26,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"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",[40,56,68,81],{"facility":41,"status":42,"city":43,"state":44,"zip":26,"country":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Anhui Provincial Center for Disease Control and Prevention","RECRUITING","Hefei","Anhui","China",{"type":47,"coordinates":48},"Point",[49,50],117.28083,31.86389,{"lat":50,"lon":49},[53],{"name":54,"role":36,"phone":55,"phoneExt":26,"email":26},"Tang Jihai","15395002840",{"facility":57,"status":42,"city":58,"state":26,"zip":26,"country":45,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"Fujian Provincial Center for Disease Control and Prevention","Fujian",{"type":47,"coordinates":60},[61,62],106.12972,28.92651,{"lat":62,"lon":61},[65],{"name":66,"role":36,"phone":67,"phoneExt":26,"email":26},"Zhang Dongjuan","13799327516",{"facility":69,"status":42,"city":70,"state":26,"zip":71,"country":45,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Guangdong Provincial Center for Disease Control and Prevention","Guangdong","650000",{"type":47,"coordinates":73},[74,75],129.33635,42.76832,{"lat":75,"lon":74},[78],{"name":79,"role":36,"phone":80,"phoneExt":26,"email":26},"Huang Zhuhang","13602438596",{"facility":82,"status":42,"city":83,"state":26,"zip":26,"country":45,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"Hubei Provincial Center for Disease Control and Prevention","Hubei",{"type":47,"coordinates":85},[86,87],120.41732,29.08114,{"lat":87,"lon":86},[90],{"name":91,"role":36,"phone":26,"phoneExt":26,"email":26},"Tong Yeqing",{"type":93,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","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":105,"type":106},8000,"ESTIMATED","INTERVENTIONAL",[109],"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.",[112],"Hand, Foot, and Mouth Disease（HFMD)",[114,115,116,117,118,119,120,121],"bivalent enterovirus inactivated vaccine","Hand, Foot, and Mouth Disease","EV71","CA16","PHASE Ⅲ","vaccine efficacy","immonogenicity","safety","2024-12-31",{"date":124,"type":125},"2025-01-01","ACTUAL",{"date":127,"type":125},"2024-12-13",{"date":129,"type":106},"2026-11-30",{"name":5,"class":6},4]