{"id":"two-doses-enterovirus-71-vaccine","safety":{"commonSideEffects":[{"rate":null,"effect":"Local injection site reactions (pain, erythema, swelling)"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Irritability or fussiness"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Enterovirus 71 vaccine contains inactivated virus 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 infection and severe disease manifestations such as hand, foot, and mouth disease and neurological complications.","oneSentence":"This inactivated vaccine stimulates the immune system to produce antibodies and cellular immunity against enterovirus 71, preventing infection and disease.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:42:13.515Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of enterovirus 71 infection and associated hand, foot, and mouth disease"},{"name":"Prevention of enterovirus 71-associated neurological complications in infants and young children"}]},"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":"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 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":"NCT05913024","phase":"PHASE2","title":"Immunogenicity and Safety of Enterovirus Type 71 Vaccine,Inactivated(Vero Cells) in Volunteers Aged From 6 to 71 Months","status":"COMPLETED","sponsor":"Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd","startDate":"2021-10-19","conditions":"Healthy Volunteers","enrollment":470},{"nctId":"NCT02001233","phase":"","title":"A Follow-up Study for a Phase III, Efficacy Trial in Inactivated Enterovirus Type 71 (EV71) Vaccine","status":"COMPLETED","sponsor":"Sinovac Biotech Co., Ltd","startDate":"2013-03","conditions":"Hand, Foot and Mouth Disease","enrollment":10077},{"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":"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":"NCT03903926","phase":"PHASE4","title":"Efficacy Trial of a Commercial EV71 Vaccine","status":"COMPLETED","sponsor":"Sinovac Biotech Co., Ltd","startDate":"2019-03-26","conditions":"Hand, Foot and Mouth Disease","enrollment":15500},{"nctId":"NCT04467541","phase":"PHASE1, PHASE2","title":"Safety & Immunogenicity of Enterovirus Type 71 Vaccine in Healthy Adults and 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":"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":"NCT03296410","phase":"PHASE4","title":"The Phase IVd of Inactivated Enterovirus 71 Vaccine","status":"UNKNOWN","sponsor":"Chinese Academy of Medical Sciences","startDate":"2017-09-14","conditions":"Hand, Foot and Mouth Disease (HFMD)","enrollment":1220},{"nctId":"NCT03281174","phase":"","title":"Five-year Immune 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":"NCT02806531","phase":"PHASE4","title":"Safety Study of Enterovirus 71 Vaccine in Children Aged 6-35 Months Old","status":"UNKNOWN","sponsor":"Beijing Chaoyang District Centre for Disease Control and Prevention","startDate":"2016-07","conditions":"Enterovirus 71 Vaccine","enrollment":20000},{"nctId":"NCT01507857","phase":"PHASE3","title":"An Efficacy Trial in Inactivated Enterovirus Type 71 (EV71) Vaccine","status":"COMPLETED","sponsor":"Sinovac Biotech Co., Ltd","startDate":"2012-01","conditions":"Hand, Foot and Mouth Disease","enrollment":10077},{"nctId":"NCT01636245","phase":"PHASE3","title":"Immunogenicity and Safety of Three Consecutive Lots of a New Inactivated Enterovirus Type 71 (EV71) Vaccine","status":"COMPLETED","sponsor":"Sinovac Biotech Co., Ltd","startDate":"2012-07","conditions":"Hand, Foot and Mouth Disease","enrollment":1400}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":18,"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":"two doses enterovirus 71 vaccine","genericName":"two doses enterovirus 71 vaccine","companyName":"Beijing Chaoyang District Centre for Disease Control and Prevention","companyId":"beijing-chaoyang-district-centre-for-disease-control-and-prevention","modality":"Biologic","firstApprovalDate":"","aiSummary":"This inactivated 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 associated hand, foot, and mouth disease, Prevention of enterovirus 71-associated neurological complications in infants and young children.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}