{"id":"ev71-vaccine","safety":{"commonSideEffects":[{"rate":null,"effect":"Injection site pain, erythema, or swelling"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Irritability or fussiness"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"EV71 vaccine is an inactivated viral vaccine containing killed enterovirus 71 particles that trigger both humoral (antibody) and cell-mediated immune responses. Upon vaccination, the immune system recognizes viral antigens and develops protective immunity, reducing the risk of EV71 infection and associated hand, foot, and mouth disease (HFMD), particularly severe neurological complications in young children.","oneSentence":"The EV71 vaccine stimulates the immune system to produce antibodies and cellular immunity against enterovirus 71, preventing infection and disease.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-27T23:46:03.335Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of enterovirus 71 infection and hand, foot, and mouth disease (HFMD) in infants and young children"}]},"trialDetails":[{"nctId":"NCT06754384","phase":"PHASE1, PHASE2","title":"Tolerability, Safety, and Immunogenicity of Tetravalent Inactivated Enterovirus Vaccine (Vero Cell).","status":"COMPLETED","sponsor":"Sinovac Biotech Co., Ltd","startDate":"2025-01-15","conditions":"Hand, Foot, and Mouth Disease (HFMD), Herpangina","enrollment":552},{"nctId":"NCT06063057","phase":"PHASE1, PHASE2","title":"Inactivated Bivalent Enterovirus Vaccine (Vero Cell) Phase I/II Clinical Trial","status":"ACTIVE_NOT_RECRUITING","sponsor":"Sinovac Biotech Co., Ltd","startDate":"2023-09-20","conditions":"Hand, Foot and Mouth Disease, Herpangina","enrollment":744},{"nctId":"NCT07178522","phase":"PHASE3","title":"A Study to Evaluate the Immunogenicity and Safety of an EV71 Vaccine (Envacgen®) in Children Aged 6 to <10 Years Compared to Children Aged 2 to <6 Years","status":"RECRUITING","sponsor":"Medigen Vaccine Biologics Corp.","startDate":"2025-06-25","conditions":"Enterovirus 71 Inactivated Vaccine","enrollment":378},{"nctId":"NCT07144202","phase":"","title":"Study on the Persistence of Immunity Following EV71 Vaccination","status":"ENROLLING_BY_INVITATION","sponsor":"Institute of Medical Biology, Chinese Academy of Medical Sciences","startDate":"2025-08-10","conditions":"Hand, Foot, and Mouth Disease, Hand, Foot, and Mouth Disease (HFMD)","enrollment":270},{"nctId":"NCT07026500","phase":"PHASE4","title":"Clinical Trial for Batch Consistency of EV71 Vaccine","status":"COMPLETED","sponsor":"Sinovac Biotech Co., Ltd","startDate":"2019-09-19","conditions":"EV71 Vaccine","enrollment":720},{"nctId":"NCT06734832","phase":"PHASE3","title":"Efficacy, Safety, and Immunogenicity of the Bivalent Inactivated Enterovirus Vaccine (Vero Cell)","status":"RECRUITING","sponsor":"Sinovac Biotech Co., Ltd","startDate":"2024-12-13","conditions":"Hand, Foot, and Mouth Disease（HFMD)","enrollment":8000},{"nctId":"NCT05099029","phase":"PHASE3","title":"A Study to Evaluate the Efficacy, Immunogenicity and Safety of an EV71 Vaccine in Healthy Infants and Children","status":"ACTIVE_NOT_RECRUITING","sponsor":"Enimmune Corporation","startDate":"2018-06-27","conditions":"Enterovirus Infections","enrollment":3982},{"nctId":"NCT06209398","phase":"PHASE4","title":"Immunogenicity of the Inactivated EV71 Vaccine Combined With 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Programme on Immunization Vaccines","status":"COMPLETED","sponsor":"Sinovac Biotech Co., Ltd","startDate":"2019-07-26","conditions":"Hand, Foot and Mouth Disease","enrollment":372},{"nctId":"NCT03274102","phase":"PHASE4","title":"Safety and Immunogenicity of Concomitant Administration of EV71 Vaccine With EPI Vaccines","status":"COMPLETED","sponsor":"Sinovac Biotech Co., Ltd","startDate":"2017-04-22","conditions":"Hand, Foot and Mouth Disease","enrollment":780},{"nctId":"NCT03873740","phase":"PHASE4","title":"Immunogenicity and Safety of Two Different Commercial EV71 Vaccines","status":"COMPLETED","sponsor":"Sinovac Biotech Co., Ltd","startDate":"2018-11-06","conditions":"Hand, Foot and Mouth Disease","enrollment":300},{"nctId":"NCT01812135","phase":"PHASE2","title":"Safety and Immunogenicity of EV71 Vaccine With or Without Aluminum Adjuvant in Infants","status":"WITHDRAWN","sponsor":"Sinovac Biotech Co., Ltd","startDate":"2011-09","conditions":"Infection, Viral, 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Children 6-71months","status":"COMPLETED","sponsor":"International Centre for Diarrhoeal Disease Research, Bangladesh","startDate":"2019-12-24","conditions":"Hand Foot & Mouth Disease","enrollment":430},{"nctId":"NCT04637919","phase":"PHASE1","title":"Safety and Immunogenicity of High-dose IN-B001 in Healthy Subjects","status":"UNKNOWN","sponsor":"HK inno.N Corporation","startDate":"2020-12","conditions":"Hand, Foot and Mouth Disease","enrollment":30},{"nctId":"NCT04182932","phase":"PHASE1","title":"Safety and Immunogenicity of CJ-40010 in Healthy Subjects","status":"UNKNOWN","sponsor":"HK inno.N Corporation","startDate":"2019-12-02","conditions":"Hand, Foot and Mouth Disease","enrollment":60},{"nctId":"NCT03278132","phase":"PHASE4","title":"Phase IV Clinical Trial, Immunogenicity and Safety of EV71 Vaccine","status":"COMPLETED","sponsor":"Sinovac Biotech Co., Ltd","startDate":"2017-07-16","conditions":"Hand, Foot and Mouth 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Persistence Study of Inactivated Enterovirus Type 71 (EV71) Vaccine","status":"COMPLETED","sponsor":"Sinovac Biotech Co., Ltd","startDate":"2017-05-20","conditions":"Hand, Foot and Mouth Disease","enrollment":343},{"nctId":"NCT03240744","phase":"PHASE4","title":"The Phase IVc of Inactivated Enterovirus 71 Vaccine (Human Diploid Cell)","status":"UNKNOWN","sponsor":"Chinese Academy of Medical Sciences","startDate":"2017-06-22","conditions":"Hand, Foot and Mouth Disease (HFMD)","enrollment":800},{"nctId":"NCT02200237","phase":"PHASE2","title":"A Clinical Study for Inactivated Vaccine Against EV71","status":"COMPLETED","sponsor":"Medigen Vaccine Biologics Corp.","startDate":"2014-09","conditions":"Enterovirus 71 Human","enrollment":366},{"nctId":"NCT02777411","phase":"PHASE2","title":"A Study to Evaluate the Safety and Immunogenicity of EV71 Vaccine in Pediatric Subjects Aged 3 to 6 Years and 6 to 35 Months Old","status":"COMPLETED","sponsor":"Enimmune 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Used for Prevention of enterovirus 71 infection and hand, foot, and mouth disease (HFMD) in infants and young children.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":6,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}