Drugs / EV71 vaccine
last change Jul 2026 re-read 2 minutes ago

EV71 vaccine

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 · Medigen Vaccine Biologics Corp. · Wuhan Institute of Biological Products Co., Ltd
+16 more · Zhejiang Provincial Center for Disease Control and Prevention · 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 · 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 23 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 13 trials
Phase 1 NCT01273246 Jan → Jun 2011 hand, foot and mouth disease Sinovac Biotech Co., Ltd Completed No outcome recorded
Phase 1 NCT01273233 Dec 2010 → Feb 2011 enterovirus infectious disease Sinovac Biotech Co., Ltd Completed No outcome recorded
Phase 1 NCT01268787 Dec 2010 → Mar 2012 enterovirus infectious disease National Health Research Institutes, Taiwan Completed No outcome recorded
Phase 28 trials
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 No outcome recorded
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 No outcome recorded
Phase 2 NCT01421121 Jun → Sep 2011 enterovirus infectious disease Sinovac Biotech Co., Ltd Completed No outcome recorded
Phase 33 trials
Phase 3 NCT03865238 Apr 2019 → Apr 2021 enterovirus infectious disease Medigen Vaccine Biologics Corp. Completed No outcome recorded
Phase 3 NCT01636245 Jul → Sep 2012 hand, foot and mouth disease Sinovac Biotech Co., Ltd Completed No outcome recorded
Phase 3 NCT01507857 Jan 2012 → Mar 2013 hand, foot and mouth disease Sinovac Biotech Co., Ltd Completed No outcome recorded
Phase 49 trials
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 No outcome recorded
Also used as a comparator or background therapy in 2 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
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

Evidence & citations 14 cited values

Every value below carries the sentence it was read from. 32 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
21

“This study aims to evaluate the safety, reactogenicity and immunogenicity of EV71 vaccineNCT02200237

“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

NCT01399853

NCT01421121

NCT04091880

NCT03278132

NCT01636245

NCT03268083

NCT01268787

NCT07026500

NCT03296410

NCT03903926

NCT02777411

NCT01507857

NCT03274102

NCT06146088

NCT03582761

NCT04111432

NCT01812135

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
1

NCT03865238

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 Enterovirus Type 71 Vaccine ClinicalTrials.gov intervention name — accepted as the source's own label NCT01273246
1

NCT01273233

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 vaccinePMID 23541623 Mar 2013
Route Intramuscular “Adults received intramuscular injection on Days 0, 14 and 28.” PMID 22426327 Mar 2012