[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637880":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":39,"responsibleParty":100,"collaborators":25,"id":102,"slug":103,"hasResults":104,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":25,"eligibilityCriteria":108,"healthyVolunteers":109,"sex":110,"minAge":111,"maxAge":112,"enrollmentInfo":113,"targetDuration":25,"studyType":116,"phases":117,"briefSummary":119,"conditions":120,"keywords":123,"overallStatus":129,"whyStopped":25,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},{"fullName":5,"class":6},"Sinovac Biotech Co., Ltd","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Tetravalent Inactivated Enterovirus Vaccine (Vero Cell)","EXPERIMENTAL","3000 participants aged 6-71 months will receive Tetravalent Inactivated Enterovirus Vaccine (Vero Cell).Route of administration is intramuscular injection at anterolateral thigh for infants aged younger than 12 months, and at deltoid muscle of upper arm for children aged older than 12 months.",[13],"Biological: Tetravalent Inactivated Enterovirus Vaccine (Vero Cell)",{"label":15,"type":16,"description":17,"interventionNames":18},"placebo","PLACEBO_COMPARATOR","3000 participants aged 6-71 months will receive placebo .Route of administration is intramuscular injection at anterolateral thigh for infants aged younger than 12 months, and at deltoid muscle of upper arm for children aged older than 12 months.",[19],"Biological: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BIOLOGICAL","Two doses are administered with a one-month interval between each dose.",[9],null,{"type":22,"name":27,"description":23,"armGroupLabels":28,"otherNames":25},"Placebo",[15],[30],{"name":31,"affiliation":32,"role":33},"Yanxia Wang","Henan Provincial Center for Disease Control and Prevention","PRINCIPAL_INVESTIGATOR",[35],{"name":31,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","13613816598","wangyanxia99@163.com",[40,52,65,74,87],{"facility":41,"status":25,"city":42,"state":43,"zip":25,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":25},"Anhui Provincial Center for Disease Control and Prevention","Hefei","Anhui","China","CN",{"type":47,"coordinates":48},"Point",[49,50],117.28083,31.86389,{"lat":50,"lon":49},{"facility":53,"status":25,"city":54,"state":25,"zip":25,"country":44,"countryCode":45,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"Fujian Provincial Center for Disease Control and Prevention","Fujian",{"type":47,"coordinates":56},[57,58],106.12972,28.92651,{"lat":58,"lon":57},[61],{"name":62,"role":36,"phone":63,"phoneExt":25,"email":64},"Dongjuan Zhang","13799327516","q3799327516@126.com",{"facility":32,"status":25,"city":66,"state":25,"zip":25,"country":44,"countryCode":45,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"Henan",{"type":47,"coordinates":68},[69,70],112.22494,37.92189,{"lat":70,"lon":69},[73],{"name":31,"role":36,"phone":37,"phoneExt":25,"email":38},{"facility":75,"status":25,"city":76,"state":25,"zip":25,"country":44,"countryCode":45,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Hubei Provincial Center for Disease Control and Prevention","Hubei",{"type":47,"coordinates":78},[79,80],120.41732,29.08114,{"lat":80,"lon":79},[83],{"name":84,"role":36,"phone":85,"phoneExt":25,"email":86},"Yeqing Tong","13971078410","63382251@qq.com",{"facility":88,"status":25,"city":89,"state":25,"zip":25,"country":44,"countryCode":45,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"Sichuan Provincial Center for Disease Control and Prevention","Sichuan",{"type":47,"coordinates":91},[92,93],105.48032,35.1221,{"lat":93,"lon":92},[96],{"name":97,"role":36,"phone":98,"phoneExt":25,"email":99},"Yulin Jing","18081892339","21820422@qq.com",{"type":101,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100637880","phase-3-protective-efficacy--immunogenicity-and-safety-of-the-tetravalent-inactivated-enterovirus-vaccine-vero-cell-100637880",false,"NCT07611513","Protective Efficacy , Immunogenicity and Safety of the Tetravalent Inactivated Enterovirus Vaccine (Vero Cell).","Multicenter, Randomized, Double-blind, Placebo-Controlled Phase IIIa Clinical Trial on the Protective Efficacy , Immunogenicity and Safety of the Tetravalent Inactivated Enterovirus Vaccine (Vero Cell) in Children Aged 6 to 71 Months.","Inclusion Criteria:\n\n1. Healthy children aged 6 to 71 months.\n2. Guardians who can understand and voluntarily sign the informed consent form\n3. Willing and able to comply with all visit schedules, sample collection, vaccinations, and other trial procedures。\n4. Provide legal identification for the participant and their guardian\n\nExclusion Criteria:\n\n1. A known history of HFMD\u002FHA\n2. 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.\n3. Autoimmune diseases, immunodeficiency diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid diseases, asplenia, functional asplenia, and HIV infection).\n4. Abnormal coagulation function (such as coagulation factor deficiencies,and platelet abnormalities).\n5. 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\n6. Various acute diseases or exacerbations of chronic diseases within the last 3 days.\n7. Having been vaccinated with a vaccine containing any of the components EV71, CA16, CA10, CA6.\n8. Having received ≥14 days of immunosuppressive or other immunomodulatory treatment (prednisone ≥2mg\u002Fkg\u002Fday, or its equivalent; local or inhaled corticosteroids excluded) within the past 6 months, or cytotoxic treatment, or planning to receive such treatment during the trial.\n9. Having received immunoglobulin or other blood products(excluding hepatitis B immunoglobulin) within the past 6 months, or planning to receive such treatment during the trial.\n10. Having received other investigational drugs or vaccines within the past 30 days, or planning to receive such drugs or vaccines during the trial.\n11. Having received live attenuated vaccines or nucleic acid vaccines within the past 14 days, or subunit or inactivated vaccines within the past 7 days.\n12. Known allergy to any component of the investigational vaccine (inactivated EV71 virus, inactivated CA16 virus, , inactivated CA10 virus,, inactivated CA6 virus,aluminum hydroxide, sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate, injectable water).\n13. On the day of planned vaccination with the investigational vaccine, having an axillary temperature ≥37.3°C before vaccination, or other vital sign measurements outside the normal range,or the physical examination is not qualified.\n14. 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":114,"type":115},6000,"ESTIMATED","INTERVENTIONAL",[118],"PHASE3","This multicenter, randomized, double-blind, placebo-controlled phase IIIa clinical trial aims to evaluate the protective efficacy , immunogenicity and safety of the Tetravalent Inactivated Enterovirus Vaccine (Vero Cell) in Children aged 6 to 71 months.\n\nParticipants will be randomly assigned in a 1:1 ratio to the trial group and the placebo group, receiving two doses of experimental vaccine or placebo , with a one-month interval between the two doses.",[121,122],"Hand, Foot, and Mouth Disease(HFMD)","Herpangina",[124,122,125,126,127,128],"Hand, Foot, and Mouth Disease (HFMD)","phase IIIa","immunogenicity","safety","protective efficacy","NOT_YET_RECRUITING","2026-05-22",{"date":132,"type":133},"2026-05-28","ACTUAL",{"date":135,"type":115},"2026-05",{"date":137,"type":115},"2028-09",{"name":5,"class":6},5]