{"id":"ev71-inactivated-vaccine","safety":{"commonSideEffects":[{"rate":null,"effect":"Pain, redness, swelling, or itching at the injection site"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Headache"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"groq-llama-8b","explanation":"This vaccine is designed to induce a specific immune response against the EV71 virus, which can cause severe neurological diseases in children. By exposing the body to a small, inactivated piece of the virus, the vaccine stimulates the production of antibodies that can recognize and neutralize the virus, providing protection against future infections.","oneSentence":"EV71 Inactivated Vaccine works by exposing the body to a small, harmless piece of the EV71 virus to stimulate the immune system to produce antibodies and provide immunity against future EV71 infections.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:52:30.257Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of EV71 infections"}]},"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":"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 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in Chinese Children","status":"COMPLETED","sponsor":"Institute of Medical Biology, Chinese Academy of Medical Sciences","startDate":"2016-09","conditions":"Hand, Foot and Mouth Disease (HFMD)","enrollment":40724},{"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":"NCT04091880","phase":"PHASE4","title":"Evaluation of the Safety and Immunogenicity of Simultaneously Administration of EV71 Vaccine and Influenza Vaccine","status":"COMPLETED","sponsor":"China National Biotec Group Company Limited","startDate":"2019-09-26","conditions":"Enterovirus Infections, Influenza","enrollment":1134},{"nctId":"NCT04072276","phase":"","title":"Long-Term Immunogenicity Study of Inactivated EV71 Vaccine in Children","status":"COMPLETED","sponsor":"Medigen Vaccine Biologics Corp.","startDate":"2019-08-15","conditions":"Enterovirus 71 Human","enrollment":227},{"nctId":"NCT05107557","phase":"PHASE4","title":"Immunogenicity And Safety of COVID-19 Vaccine , Inactivated Co -Administration With EV71 Vaccine (Vero Cell)","status":"COMPLETED","sponsor":"Sinovac Biotech Co., Ltd","startDate":"2021-11-05","conditions":"COVID-19","enrollment":520},{"nctId":"NCT04133584","phase":"PHASE4","title":"The Immunogenicity and Safety of the Vaccination of Inactivated Enterovirus 71 Vaccine and Seasonal Influenza Vaccine","status":"COMPLETED","sponsor":"Zhejiang Provincial Center for Disease Control and Prevention","startDate":"2019-09-16","conditions":"Seasonal Influenza, Hand, Foot and Mouth Disease","enrollment":1134},{"nctId":"NCT05166044","phase":"","title":"Safety Observation of Enterovirus 71 Inactivated Vaccine (Vero Cell) Combined Immunization in 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":"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":"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 Infection","enrollment":3061},{"nctId":"NCT04111432","phase":"PHASE4","title":"Safety and Immunogenicity of Concomitant Administration of EV71 Vaccine With Expanded 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, Enterovirus","enrollment":""},{"nctId":"NCT01273246","phase":"PHASE1","title":"Safety of an Inactivated Enterovirus Type 71 Vaccines in Healthy Children","status":"COMPLETED","sponsor":"Sinovac Biotech Co., Ltd","startDate":"2011-01","conditions":"Hand-foot-mouth Disease, Infection; Viral, Enterovirus","enrollment":132},{"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":"NCT03582761","phase":"PHASE4","title":"Efficacy Evaluation for Inactivated Vaccine (Vero Cell) Against EV71","status":"COMPLETED","sponsor":"Jiangsu Province Centers for Disease Control and Prevention","startDate":"2019-05-01","conditions":"Hand, Foot and Mouth Disease","enrollment":40000},{"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":"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 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":"NCT02999828","phase":"PHASE4","title":"The Phase IVa of Inactivated Enterovirus 71 Vaccine (Human Diploid Cell, KMB-17)","status":"UNKNOWN","sponsor":"Chinese Academy of Medical Sciences","startDate":"2016-09","conditions":"Safety of Inactivated EV71 Vaccine, Immunization of Inactivated EV71 Vaccine","enrollment":20770},{"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":"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":"NCT02889497","phase":"PHASE4","title":"Safety, Three Batches Consistency and Immunity Duration of the Post-marketing Inactivated Enterovirus Type 71 (EV71) Vaccine in Children Aged 6-71 Months","status":"UNKNOWN","sponsor":"Beijing Chaoyang District Centre for Disease Control and Prevention","startDate":"2016-09","conditions":"Hand Foot and Mouth Disease","enrollment":20900},{"nctId":"NCT01376479","phase":"PHASE1","title":"Safety and Immunogenicity Study of an Inactivated Vaccine Against Hand, Foot and Mouth Disease Caused by Enterovirus 71","status":"COMPLETED","sponsor":"Inviragen Inc.","startDate":"2011-08","conditions":"Hand, Foot and Mouth Disease","enrollment":36},{"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":"NCT01734408","phase":"PHASE2","title":"A Booster Dose of Inactivated Vaccine (Vero Cell) Against EV71 in Chinese Children","status":"COMPLETED","sponsor":"Jiangsu Province Centers for Disease Control and Prevention","startDate":"2012-11","conditions":"EV71-associated Disease","enrollment":773},{"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},{"nctId":"NCT01508247","phase":"PHASE3","title":"A Clinical Trial to Assess the Efficacy and Safety of an Inactivated Vaccine (Vero Cell) Against EV71 in Chinese Children Aged 6-35 Months","status":"COMPLETED","sponsor":"Jiangsu Province Centers for Disease Control and Prevention","startDate":"2012-01","conditions":"Hand, Foot and Mouth Disease, Herpangina, Other EV71-associated Diseases","enrollment":10245},{"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},{"nctId":"NCT01273233","phase":"PHASE1","title":"Safety of an Inactivated Enterovirus Type 71 Vaccine in Healthy Adults","status":"COMPLETED","sponsor":"Sinovac Biotech Co., Ltd","startDate":"2010-12","conditions":"Infection; Viral, Enterovirus","enrollment":36},{"nctId":"NCT01421121","phase":"PHASE2","title":"Safety and Immunogenicity of an Inactivated EV71 Vaccine in Infants","status":"COMPLETED","sponsor":"Sinovac Biotech Co., Ltd","startDate":"2011-06","conditions":"Infection, Viral, 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Prevention","startDate":"2011-01","conditions":"Hand, Foot and Mouth Disease","enrollment":100}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_2","status":"active","brandName":"EV71 Inactivated Vaccine","genericName":"EV71 Inactivated Vaccine","companyName":"Sinovac Biotech Co., Ltd","companyId":"sinovac-biotech-co-ltd","modality":"Biologic","firstApprovalDate":"","aiSummary":"The EV71 Inactivated Vaccine is a vaccine component that induces an immune response through biological mechanisms. It is used to prevent Hand, Foot and Mouth Disease, Enterovirus 71 Human, Herpangina, and other EV71-associated diseases, and is typically administered in a dose of 400U /0.5ml.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}