{"id":"ev71-inoculation-vaccine","safety":{"commonSideEffects":[{"rate":null,"effect":"Injection site pain, erythema, or swelling"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Myalgia or fatigue"}]},"_chembl":{"chemblId":"CHEMBL2108573","moleculeType":"Vaccine component"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The vaccine contains inactivated or attenuated EV71 virus particles that trigger both humoral (antibody) and cell-mediated immune responses. Upon exposure to wild-type EV71, the primed immune system recognizes and neutralizes the virus, preventing viral replication and the development of hand, foot, and mouth disease (HFMD) and its severe neurological complications.","oneSentence":"EV71 vaccine stimulates the immune system to produce antibodies and cellular immunity against Enterovirus 71, preventing infection and disease.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:35:58.203Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of Enterovirus 71 infection and hand, foot, and mouth disease (HFMD)"}]},"trialDetails":[{"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":"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 Hepatitis B and Group A Meningococcal Vaccine","status":"UNKNOWN","sponsor":"Jiangsu Province Centers for Disease Control and Prevention","startDate":"2018-05-24","conditions":"Hand, Foot and Mouth Disease","enrollment":510},{"nctId":"NCT04993365","phase":"PHASE4","title":"Immunogenicity And Safety of COVID-19 Vaccine , 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Shanghai","status":"UNKNOWN","sponsor":"Sinovac Biotech Co., Ltd","startDate":"2022-01-04","conditions":"Hand, Foot and Mouth Disease","enrollment":12500},{"nctId":"NCT05397587","phase":"PHASE4","title":"An Immunity Persistence Study of Enterovirus 71 Inactivated Vaccine (Vero Cell)","status":"UNKNOWN","sponsor":"Sinovac Biotech Co., Ltd","startDate":"2022-07-30","conditions":"Hand, Foot and Mouth Disease","enrollment":474},{"nctId":"NCT03909074","phase":"PHASE3","title":"Clinical Trial of Enterovirus 71（EV71） Inactivated Vaccine in Children Aged 36-71 Months","status":"COMPLETED","sponsor":"Sinovac Biotech Co., Ltd","startDate":"2019-03-10","conditions":"Hand, Foot and Mouth Disease","enrollment":900},{"nctId":"NCT03865238","phase":"PHASE3","title":"A Study to Evaluate the Efficacy, Safety, and Immunogenicity of an EV71 Vaccine","status":"COMPLETED","sponsor":"Medigen Vaccine Biologics Corp.","startDate":"2019-04-23","conditions":"Enterovirus 71 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Commercial EV71 Vaccines","status":"COMPLETED","sponsor":"Sinovac Biotech Co., Ltd","startDate":"2018-11-06","conditions":"Hand, Foot and Mouth Disease","enrollment":300},{"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 Disease","enrollment":120},{"nctId":"NCT03519568","phase":"PHASE4","title":"Clinical Study on Combined Immune Effect of EV71 Inactivated Vaccine","status":"UNKNOWN","sponsor":"Shandong Province Centers for Disease Control and Prevention","startDate":"2018-03-01","conditions":"Enterovirus 71 Inactivated Vaccine, HFMD","enrollment":1944},{"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 Corporation","startDate":"2014-12","conditions":"Enterovirus Infections","enrollment":122},{"nctId":"NCT01268787","phase":"PHASE1","title":"A Study to Evaluate the Safety and Immunogenicity of EV71 Vaccine","status":"COMPLETED","sponsor":"National Health Research Institutes, Taiwan","startDate":"2010-12","conditions":"Enterovirus Infection","enrollment":60},{"nctId":"NCT01679665","phase":"PHASE2","title":"Systems Biology of Vaccination for EV71 Vaccine in Humans","status":"COMPLETED","sponsor":"Jiangsu Province Centers for Disease Control and Prevention","startDate":"2012-08","conditions":"Systems Biology, Early Gene, EV71 Vaccine","enrollment":72}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":147,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"EV71 (inoculation vaccine)","genericName":"EV71 (inoculation vaccine)","companyName":"Shandong Province Centers for Disease Control and Prevention","companyId":"shandong-province-centers-for-disease-control-and-prevention","modality":"Biologic","firstApprovalDate":"","aiSummary":"EV71 vaccine stimulates the immune system to produce antibodies and cellular immunity against Enterovirus 71, preventing infection and disease. Used for Prevention of Enterovirus 71 infection and hand, foot, and mouth disease (HFMD).","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}