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Drugs / EV71 vaccine
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EV71 vaccine

also known as inactivated enterovirus 71 vaccine · enterovirus 71 (EV71) vaccine · enterovirus 71 vaccine · EV71 vaccine (Vero cell) · EV71vac · Inactivated enterovirus 71 vaccine (human diploid cell) · inactivated enterovirus A71 vaccine · inactivated EV71 vaccine · +2 more

Vaccine

Developed for
hand, foot and mouth disease · enterovirus infectious disease · enterovirus antenatal infection
Investigated by
Sinovac Biotech Co., Ltd · Jiangsu Province Centers for Disease Control and Prevention · Bejing Vigoo Biological Co., LTD · Enimmune Corporation · Wuhan Institute of Biological Products Co., Ltd · Zhejiang Provincial Center for Disease Control and Prevention
+16 more · Centers for Disease Control and Prevention, China · Changchun Institute of Biological Products Co., Ltd. · China National Biotec Group Company Limited · Guangdong Center for Disease Prevention and Control · Guizhou Center for Disease Control and Prevention · Henan Center for Disease Control and Prevention · Hubei Provincial Center for Disease Control and Prevention · Hunan Provincial Center for Disease Control and Prevention · Institute of Medical Biology, Chinese Academy of Medical Sciences · Medigen Vaccine Biologics Corp. · National Health Research Institutes, Taiwan · National Institutes for Food and Drug Control, China · Peking University · Shaanxi Provincial Center for Disease Control and Prevention · Shandong Province Centers for Disease Control and Prevention · Shangyu District Center for Disease Control and Prevention

Trials 21

today NCT07793175 · not/applicable NCT06146088 · Ph 4 NCT05107557 · Ph 4 NCT04091880 · Ph 4 NCT07026500 · Ph 4 NCT03582761 · Ph 4 NCT03903926 · Ph 4 NCT03519568 · Ph 4 NCT03278132 · Ph 4 NCT03274102 · Ph 4 NCT03268083 · Ph 2 NCT02777411 · Ph 2 NCT02200237 · Ph 2 NCT01734408 · Ph 2 NCT01679665 · Ph 2 NCT01636245 · Ph 3 NCT01507857 · Ph 3 NCT01812135 · Ph 2 NCT01399853 · Ph 2 NCT01421121 · Ph 2 NCT01268787 · Ph 1
20112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT01268787 Dec 2010 → Mar 2012 enterovirus infectious disease National Health Research Institutes, Taiwan Completed No outcome recorded
Phase 28 trials · 2 met primary
Phase 2 NCT03268083 Jul 2016 → Aug 2017 enterovirus infectious disease Enimmune Corporation Completed No outcome recorded
Phase 2 NCT02777411 Dec 2014 → Jan 2016 enterovirus infectious disease Enimmune Corporation Completed No outcome recorded
Phase 2 NCT02200237 Sep 2014 → May 2017 enterovirus infectious disease Medigen Vaccine Biologics Corp. Completed No outcome recorded
Phase 2 NCT01734408 Nov 2012 → Jan 2013 hand, foot and mouth disease Jiangsu Province Centers for Disease Control and Prevention Completed Met primary
Phase 2 NCT01679665 Aug 2012 → May 2013 early response to neural induction gene, enterovirus antenatal infection Jiangsu Province Centers for Disease Control and Prevention Completed No outcome recorded
Phase 2 NCT01812135 Sep → Nov 2011 enterovirus infectious disease Sinovac Biotech Co., Ltd Withdrawn No outcome recorded
Phase 2 NCT01399853 Jul → Nov 2011 — Jiangsu Province Centers for Disease Control and Prevention Completed Met primary
Phase 2 NCT01421121 Jun → Sep 2011 enterovirus infectious disease Sinovac Biotech Co., Ltd Completed No outcome recorded
Phase 32 trials · 2 met primary
Phase 3 NCT01636245 Jul → Sep 2012 hand, foot and mouth disease Sinovac Biotech Co., Ltd Completed Met primary
Phase 3 NCT01507857 Jan 2012 → Mar 2013 hand, foot and mouth disease Sinovac Biotech Co., Ltd Completed Met primary
Phase 49 trials · 1 met primary
Phase 4 NCT06146088 Nov 2023 → Mar 2024 hand, foot and mouth disease Institute of Medical Biology, Chinese Academy of Medical Sciences Unknown No outcome recorded
Phase 4 NCT05107557 Nov → Dec 2021 COVID-19 Sinovac Biotech Co., Ltd Completed No outcome recorded
Phase 4 NCT04091880 Sep 2019 → Jan 2020 enterovirus infectious disease, influenza China National Biotec Group Company Limited Completed No outcome recorded
Phase 4 NCT07026500 Sep 2019 → Apr 2020 — Sinovac Biotech Co., Ltd Completed No outcome recorded
Phase 4 NCT03582761 May 2019 → May 2020 hand, foot and mouth disease Jiangsu Province Centers for Disease Control and Prevention Completed No outcome recorded
Phase 4 NCT03903926 Mar 2019 → Jun 2020 hand, foot and mouth disease Sinovac Biotech Co., Ltd Completed No outcome recorded
Phase 4 NCT03519568 Mar → Dec 2018 enterovirus antenatal infection, hand, foot and mouth disease Shandong Province Centers for Disease Control and Prevention Unknown No outcome recorded
Phase 4 NCT03278132 Jul → Sep 2017 hand, foot and mouth disease Sinovac Biotech Co., Ltd Completed No outcome recorded
Phase 4 NCT03274102 Apr → Nov 2017 hand, foot and mouth disease Sinovac Biotech Co., Ltd Completed Met primary
Phase not applicable1 trial
— NCT07793175 Sep 2026 → Jan 2027 expected hand, foot and mouth disease Sinovac Biotech Co., Ltd Not yet recruiting No outcome recorded
Comparator or background therapy2 trials
Phase 4 NCT04111432 Comparator Jul → Nov 2019 hand, foot and mouth disease Sinovac Biotech Co., Ltd Completed No outcome recorded
Phase 4 NCT03296410 Comparator Sep 2017 → Sep 2019 hand, foot and mouth disease Chinese Academy of Medical Sciences Unknown No outcome recorded

News releases announcing trial results or a regulatory action · 8

DateIssuerRelease
2024-11-28 Sinovac Biotech Co., Ltd Results 最新研究：SINOVAC科兴EV71疫苗与多种其他疫苗在6-11月龄婴儿中同时接种安全性良好 sinovac.com ↗
2022-06-09 Sinovac Biotech Co., Ltd Results SINOVAC科兴EV71疫苗益尔来福 ® 上市六年来临床研究回顾 sinovac.com ↗
2022-04-20 Sinovac Biotech Co., Ltd Results SINOVAC科兴EV71疫苗益尔来福®最新研究进一步丰富了与免疫规划疫苗同时接种的证据 sinovac.com ↗
研究结果显示：SINVOAC科兴的EV71疫苗益尔来福 ® 与麻腮风疫苗和乙脑减毒活疫苗同时接种对相应组分的免疫效果没有影响，并显示出良好的安全性。
2021-06-11 Sinovac Biotech Co., Ltd Regulatory SINOVAC科兴EV71疫苗益尔来福®获批扩大适用年龄范围至71月龄，帮助更多儿童免受EV71所致手足口病困扰 sinovac.com ↗
2021-06-09 Sinovac Biotech Co., Ltd Results 美国《儿科传染病学会杂志》发表科兴肠道病毒71型灭活疫苗在 36-71月龄儿童中的免疫原性和安全性研究结果 sinovac.com ↗
研究结果显示，SINOVAC的肠道病毒71型灭活疫苗（EV71疫苗）益尔来福 ® 在36-71月龄儿童中接种具有良好的安全性及免疫原性，该年龄组儿童接种益尔来福 ® 后，中和抗体阳转率及GMI（几何平均增长倍数）均显著优效于同年龄段对照组。
2021-04-11 Medigen Vaccine Biologics Corp. Results 高端疫苗「腸病毒71型疫苗」多國多中心三期臨床試驗，免疫數據解盲 medigenvac.com ↗
高端腸病毒71型疫苗三期臨床試驗，於台灣及越南完成超過3,000人收案，在進一步完成受試者施打一年後的血清檢體採集、及實驗室數據分析後，於110年4月10日完成免疫生成性數據解盲，且數據達到台灣法規單位建議標準。
2019-04-08 Sinovac Biotech Co., Ltd Results 北京科兴EV71疫苗联合免疫研究成果受到国际广泛关注 sinovac.com ↗
结果表明联合免疫不会影响疫苗的免疫原性和安全性。
2014-02-27 Sinovac Biotech Co., Ltd Results 北京科兴自主研发的EV71疫苗Ⅲ期临床试验结果在新英格兰医学杂志发表 sinovac.com ↗
当地时间 2014 年 2 月 26 日下午，北京科兴自主研发的肠道病毒 71 型（ EV71 ）疫苗Ⅲ期临床试验结果在新英格兰医学杂志 ( New England Journal of Medicine ) 网站在线发表。

All press releases naming this drug 8 releases

DateIssuerRelease

Evidence & citations 13 cited values

Every value below carries the sentence it was read from. 30 sources stand behind the page.

FieldValueCited text
Known as EV71 vaccine “A booster dose of alum-adjuvant 160U /0.5ml EV71 vaccine in 160 children whom had received two doses of alum-adjuvant 160U/0.5ml EV71 vaccines one year before.” NCT01734408 ↗
22

“This study aims to evaluate the safety, reactogenicity and immunogenicity of EV71 vaccine” NCT02200237 ↗

“the enterovirus 71 vaccine (EV71 vaccine) administered alone or simultaneously” PMID 35746502 ↗ Jun 2022

“EV71 vaccine has good safety profile and was immunogenic.” NCT01679665 ↗

“The EV71 vaccine was manufactured by Sinovac Biotech Co.” NCT05107557 ↗

NCT01421121 ↗

NCT07026500 ↗

NCT03582761 ↗

NCT02777411 ↗

NCT03274102 ↗

NCT03296410 ↗

Show 12 more sources
Known as enterovirus 71 (EV71) vaccine “This study tested the hypothesis that the immunogenicity and safety of the simultaneous administration of enterovirus 71 (EV71) vaccine (dose 1) with recombinant hepatitis B...” PMID 30891604 ↗ Jul 2019
Known as enterovirus 71 vaccine “The aim of this study was to investigate the immunogenicity and safety of the enterovirus 71 vaccine (EV71 vaccine) administered alone or simultaneously.” PMID 35746502 ↗ Jun 2022
Known as EV71 vaccine (Vero cell) “A Randomized and Controlled Phase IV Clinical Trial to Evaluate the Immunogenicity and Safety of COVID-19 Vaccine (Vero Cell), Inactivated Co-administrated With EV71 Vaccine...” NCT05107557 ↗
Known as EV71vac “a formalin-inactivated EV71 vaccine candidate (EV71vac) at 5- and 10-µg doses” PMID 24278177 ↗ Nov 2013
Known as inactivated enterovirus 71 vaccine “BACKGROUND: Few data exist on the immunogenicity and safety of an inactivated enterovirus 71 vaccine (EV71 vaccine) coadministered with trivalent split-virion inactivated...” PMID 36569946 ↗ Dec 2022
1

“Immunogenicity, safety, and lot consistency of a novel inactivated enterovirus 71 vaccine in Chinese children aged 6 to 59 months.” PMID 24108780 ↗ Oct 2013
Known as Inactivated enterovirus 71 vaccine (human diploid cell) “Inactivated enterovirus 71 vaccine (human diploid cell) of 3.0EU/0.5mL on Day 0,30” NCT06146088 ↗
Known as inactivated enterovirus A71 vaccine “Immunogenicity and safety of an inactivated enterovirus A71 vaccine in children 3-6 years and 2-35 months of age- an open-label, randomized phase IIb clinical trial.” PMID 31399275 ↗ Aug 2019
Known as inactivated EV71 vaccine “the inactivated EV71 vaccine (vero cell) had a clinically acceptable safety and good immunogenicity for healthy Chinese infants” NCT01636245 ↗
Known as inactivated whole EV-A71 virus vaccine “The immunogenicity and safety of an inactivated whole EV-A71 virus vaccine were assessed in children 2 months to 6 years of age.” PMID 31399275 ↗ Aug 2019
Known as KMB-17 “infants vaccined with two dose (3.0 EU/dose) of inactivated enterovirus 71 vaccine (KMB-17) at 8 months old and 9 months old (namely interval one month).” NCT03296410 ↗
Modality Vaccine “an inactivated alum-adjuvanted EV71 whole-virus vaccine” PMID 23541623 ↗ Mar 2013
Route Intramuscular “two intramuscular doses of either EV71 vaccine or placebo, 28 days apart” PMID 24571754 ↗ Feb 2014