[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hand-foot-and-mouth-diseasehfmd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hand-foot-and-mouth-diseasehfmd":61},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"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":21,"type":22},6000,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29],"Hand, Foot, and Mouth Disease(HFMD)","Herpangina",[31,29,32,33,34,35],"Hand, Foot, and Mouth Disease (HFMD)","phase IIIa","immunogenicity","safety","protective efficacy","NOT_YET_RECRUITING","2026-05-22",{"date":39,"type":40},"2026-05-28","ACTUAL",{"date":42,"type":22},"2026-05",{"date":44,"type":22},"2028-09",{"name":46,"class":47},"Sinovac Biotech Co., Ltd","INDUSTRY",5,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},"100572558","phase-3-efficacy-safety-and-immunogenicity-of-the-bivalent-inactivated-enterovirus-vaccine-vero-cell-100572558","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.",{"count":57,"type":22},8000,[25],"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.",[61],"Hand, Foot, and Mouth Disease（HFMD)",[63,64,65,66,67,68,69,34],"bivalent enterovirus inactivated vaccine","Hand, Foot, and Mouth Disease","EV71","CA16","PHASE Ⅲ","vaccine efficacy","immonogenicity","RECRUITING","2024-12-31",{"date":73,"type":40},"2025-01-01",{"date":75,"type":40},"2024-12-13",{"date":77,"type":22},"2026-11-30",{"name":46,"class":47},4]