{"id":"ev71-vaccine-only","safety":{"commonSideEffects":[{"rate":null,"effect":"Injection site pain, redness, or swelling"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Irritability or fussiness"},{"rate":null,"effect":"Loss of appetite"}]},"_chembl":{"chemblId":"CHEMBL2108573","moleculeType":"Vaccine component"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"This is an inactivated viral vaccine containing killed Enterovirus 71 particles that triggers 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":"high"},"_scrapedAt":"2026-03-28T00:35:57.794Z","_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":"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":"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":"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":"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":"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":"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}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"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 Vaccine only","genericName":"EV71 Vaccine only","companyName":"Sinovac Biotech Co., Ltd","companyId":"sinovac-biotech-co-ltd","modality":"Biologic","firstApprovalDate":"","aiSummary":"The 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) in infants and young children.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":2,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}