Drugs / EV71
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT04133584 | Sep 2019 → Jun 2021 | hand, foot and mouth disease, influenza | Zhejiang Provincial Center for Disease Control and Prevention | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2026-03-17 | Medigen Vaccine Biologics Corp. | Regulatory 高端恩穩健成功取得越南首張腸病毒71型疫苗藥證，攜手Substipharm Biologics拓展東南亞商業布局 medigenvac.com ↗
高端疫苗生物製劑股份有限公司（MVC）與 Substipharm Biologics 今日 (2026/03/17) 共同宣布，恩穩健（ENVACGEN®）腸病毒71型（EV-A71）疫苗已正式取得越南藥品管理局（DAV）核發之藥品上市許可。 |
| 2024-12-19 | Medigen Vaccine Biologics Corp. | Results 越南巴斯德與高端疫苗共同舉辦腸病毒專家會議 獲得廣大迴響 medigenvac.com ↗
本次臨床試驗的疫苗組中皆無確診個案，且疫苗統計學有效性高達96.8%，試驗結果發表於國際權威醫學期刊《刺胳針》(The Lancet)，證明這支疫苗除具備豐富的實證醫學數據，也是越南當地臨床試驗的重要標竿。 |
| 2023-07-06 | Institute of Vaccines and Medical Biologicals, Vietnam | Results Việt Nam sắp có vaccine tay chân miệng ngừa chủng nguy hiểm nhất com.vn ↗
ghi nhận vaccine giúp bảo vệ trẻ chống lại bệnh tay chân miệng do EV71 ở bất kỳ độ nặng nào, hiệu quả 96,8%. |
| 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。 |
| 2019-03-21 | Medigen Vaccine Biologics Corp. | Regulatory 高端疫苗腸病毒EV71型疫苗 全球首獲越南衛生部核准3期臨床試驗 medigenvac.com ↗
本公司之腸病毒71型疫苗於今(3/21)日獲越南衛生部(Ministry of Health of Vietnam)核准進行第三期臨床試驗，加上先前已取得之台灣衛福部核准，本公司腸病毒71型疫苗將展開多國多中心第三期臨床試驗，台、越兩地總收案人數為3,000~3400人，可望於今年完成收案。 |
All press releases naming this drug 8 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-05-29 | PT Kalbe Farma Tbk | Kalventis Encourages Family Protection Through Adult Vaccination and the EV71 HFMD Vaccine co.id ↗ |
| 2026-03-17 | Medigen Vaccine Biologics Corp. | 高端恩穩健成功取得越南首張腸病毒71型疫苗藥證，攜手Substipharm Biologics拓展東南亞商業布局 medigenvac.com ↗ |
| 2024-12-19 | Medigen Vaccine Biologics Corp. | 越南巴斯德與高端疫苗共同舉辦腸病毒專家會議 獲得廣大迴響 medigenvac.com ↗ |
| 2023-07-06 | Institute of Vaccines and Medical Biologicals, Vietnam | Việt Nam sắp có vaccine tay chân miệng ngừa chủng nguy hiểm nhất com.vn ↗ |
| 2023-04-12 | Medigen Vaccine Biologics Corp. | 高端腸病毒71型（EV71）疫苗取得衛福部查驗登記核准，預計供貨時間為今年第三季起 medigenvac.com ↗ |
| 2021-04-11 | Medigen Vaccine Biologics Corp. | 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 ↗ |
| 2019-03-21 | Medigen Vaccine Biologics Corp. | 高端疫苗腸病毒EV71型疫苗 全球首獲越南衛生部核准3期臨床試驗 medigenvac.com ↗ |
| 2015-05-14 | Sinovac Biotech Co., Ltd | 北京科兴获得肠道病毒71型（EV71）灭活疫苗生产现场检查通知 sinovac.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | EV71 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04133584 ↗ |
| Known as | Inactivated Enterovirus 71 Vaccine | “Inactivated Enterovirus 71 Vaccine (EV71)” NCT04133584 ↗ |
| Modality | Vaccine | “Inactivated Enterovirus 71 Vaccine (EV71)” NCT04133584 ↗ |