Clinical trials: EV71
EV71
e- Ab Sensor - Based Real-time Diagnosis of Enterovirus Type 71
To develop a real-time diagnostic technique with e- Ab sensor for Entervirus 71 detection, the investigators conduct a prospective clinical study.
- Trial name
- NCT01388049
- Testing
- Electrosensing antibody probing system (e- Ab sensor)
- Where
- Taiwan
- Volunteers
- 72 people
- Sponsor
- National Taiwan University Hospital
Enterovirus Infections
An Extension Study of EV-BR1701 Part A1
To determine the long-term immunogenicity more than 5 years after EnVAX-A71 vaccination in the pediatric population aged 2 months to <6 years when first vaccinated.
- Trial name
- NCT07635966
- Where
- 4 sites in Taiwan
- Volunteers
- 180 people
- Sponsor
- Enimmune Corporation
The Study Focused on the Safety of Inactivated EV71 Vaccine (Human Diploid Cell) Against Hand, Foot and Mouth Disease in Chinese Children and Infants
A Phase II, Safety and Efficacy Study of Inactivated EV 71 Vaccine (Human Diploid Cell, KMB-17) in Chinese Infants
Enterovirus 71 (EV71), a major pathogen that is responsible for causing hand-foot-and-mouth disease (HFMD) worldwide, is a member of the Human Enterovirus species A, family Picornaviridae.
- Trial name
- NCT01512706
- Testing
- 160Eu/0.5ml in infants (6-11 months old), 320Eu/0.5ml in infants (6-11 months old), 640Eu/0.5ml in infants (6-11 months old)
- Where
- China
- Volunteers
- 660 people, healthy volunteers welcome
- Sponsor
- Institute of Medical Biology, Chinese Academy of Medical Sciences
COVID-19
Immunogenicity And Safety of COVID-19 Vaccine , Inactivated Co -Administration With EV71 Vaccine (Vero Cell)
This study is a randomized and controlled phase Ⅳ clinical trial of the COVID-19 vaccine (Vero cell), Inactivated manufactured by Sinovac Research \& Development Co., Ltd.
- Trial name
- NCT04993365
- Testing
- Experimental Group, Control Group
- Where
- 2 sites in China
- Volunteers
- 520 people, healthy volunteers welcome
- Sponsor
- Sinovac Research and Development Co., Ltd.
Hand, Foot and Mouth Disease
A Follow-up Study for a Phase III, Efficacy Trial in Inactivated Enterovirus Type 71 (EV71) Vaccine
The purpose of this follow-up study is to evaluate the two-year efficacy, immunogenicity and safety of EV71 Vaccines in preventing Hand, Foot and Mouth disease caused by EV71 in a total 10,000 healthy infants volunteers aged from…
- Trial name
- NCT02001233
- Testing
- EV71 vaccine
- Where
- 3 sites in China
- Volunteers
- 10,077 people, healthy volunteers welcome
- Sponsor
- Sinovac Biotech Co., Ltd
Central Nervous System Infection
Long Term Outcomes of EV71 CNS Infection
Our study involved 142 children with EV71 CNS infections that included 61 (43%) with viral meningitis, 53 (37%) with severe CNS involvement including encephalitis, polio-like syndrome and encephalomyelitis, and 28 (20%) with…
- Trial name
- NCT00172393
- Where
- Taiwan
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- National Taiwan University Hospital
Hand, Foot and Mouth Disease
Efficacy Trial of a Commercial EV71 Vaccine
The purpose of this post-marketing study is to evaluate the efficacy, immunogenicity, and safety of the EV71 vaccine post marketing, and explore the protective levels of various enterovirus neutralizing antibodies
- Trial name
- NCT03903926
- Testing
- 5000 volunteers (6-35 months)-EV71 vaccine
- Where
- 2 sites in China
- Volunteers
- 15,500 people, healthy volunteers welcome
- Sponsor
- Sinovac Biotech Co., Ltd
Hand, Foot and Mouth Disease
Immunogenicity and Safety of Two Different Commercial EV71 Vaccines
The purpose of this study is to evaluate the immunogenicity and safety of sequential vaccination of two EV71 inactived vaccines in healthy infants aged 6-35 months.
- Trial name
- NCT03873740
- Testing
- EV71 inactived vaccine（Vero cells）, EV71 inactived vaccine（Human diploid cells）
- Where
- China
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Sinovac Biotech Co., Ltd
Enterovirus Infections
A Study to Evaluate the Safety and Immunogenicity of EV71 Vaccine in Pediatric Subjects Aged 3 to 6 Years and 6 to 35 Months Old
The objectives of this study are to evaluate the immune response and safety profiles of two injections of EV71 vaccine administrated with or without adjuvant AlPO4 at 0.5-μg, 1-μg, 2-μg and 5-μg dose (if required) in children…
- Trial name
- NCT02777411
- Testing
- EV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AIPO4] per dose), EV71 vaccine ([1 μg total protein + adjuvant 150 μg AIPO4] per dose), EV71 vaccine ([2 μg total protein + adjuvant 150 μg AIPO4] per dose)
- Where
- 4 sites in Taiwan
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- Enimmune Corporation
The Efficacy of Inactivated EV71 Vaccine (KMB17) Against HFMD in Chinese Children and Infants
A Protected Study of Inactivated EV71 Vaccine (Human Diploid Cell, KMB-17) in Chinese Infants and Children
Enterovirus 71 (EV71), a major pathogen that is responsible for causing hand-foot-and-mouth disease (HFMD) worldwide, is a member of the Human Enterovirus species A, family Picornaviridae.
- Trial name
- NCT01569581
- Testing
- 100U/0.5ml in 6-11 months old infants, 100U/0.5ml in 12-23 months old infants, 100U/0.5ml in 24-35 months old children
- Where
- China
- Volunteers
- 12,000 people, healthy volunteers welcome
- Sponsor
- Institute of Medical Biology, Chinese Academy of Medical Sciences
Healthy Volunteers
Immunogenicity and Safety of Enterovirus Type 71 Vaccine,Inactivated(Vero Cells) in Volunteers Aged From 6 to 71 Months
The goal of this clinical trial is to evaluate the immunogenicity and safety of Enterovirus Type 71 Vaccine,Inactivated(Vero Cells) in healthy volunteers aged from 6 to 71 months.
- Trial name
- NCT05913024
- Testing
- Enterovirus Type 71 Vaccine
- Where
- China
- Volunteers
- 470 people, healthy volunteers welcome
- Sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Hand, Foot and Mouth Disease
Safety and Immunogenicity of Concomitant Administration of EV71 Vaccine With Expanded Programme on Immunization Vaccines
The purpose of this study is to evaluate the safety and immunogenicity of concomitant administration of EV71 vaccine with measles mumps, and rubella combined live attenuated vaccine/ encephalitis live attenuated vaccine.
- Trial name
- NCT04111432
- Testing
- Concomitant administration of EV71vaccine with EPI vaccines, Single injection of EPI vaccine, EV71 Vaccine only
- Where
- China
- Volunteers
- 372 people, healthy volunteers welcome
- Sponsor
- Sinovac Biotech Co., Ltd
Hand Foot and Mouth Disease
Safety, Three Batches Consistency and Immunity Duration of the Post-marketing Inactivated Enterovirus Type 71 (EV71) Vaccine in Children Aged 6-71 Months
This study evaluates the safety,three batches consistency and immunity duration of the post-marketing inactivated Enterovirus Type 71 (EV71) vaccine in children aged 6-71 months.This study has two groups:safety observation group…
- Trial name
- NCT02889497
- Testing
- the first batch vaccine, the second batch vaccine, the third batch vaccine
- Volunteers
- 20,900 people, healthy volunteers welcome
- Sponsor
- Beijing Chaoyang District Centre for Disease Control and Prevention
Hand, Foot, and Mouth Disease（HFMD)
Efficacy, Safety, and Immunogenicity of the Bivalent Inactivated Enterovirus Vaccine (Vero Cell)
This multicenter, randomized, double-blind, controlled Phase III clinical trial aims to evaluate the efficacy, safety, and immunogenicity of the bivalent enterovirus-inactivated vaccine (Vero cell) in healthy children aged 6 to…
- Trial name
- NCT06734832
- Testing
- bivalent enterovirus vaccine (Vero cell), inactivated, Enterovirus Type 71 Vaccine (Vero Cell), Inactivated
- Where
- 4 sites in China
- Volunteers
- 8,000 people, healthy volunteers welcome
- Sponsor
- Sinovac Biotech Co., Ltd
Hand, Foot and Mouth Disease
A Safety Study of Inactivated EV71 Vaccine (Human Diploid Cell, KMB-17) in Chinese Adults, Children and Infants
Enterovirus 71 (EV71), a major pathogen that is responsible for causing hand-foot-and-mouth disease (HFMD) worldwide, is a member of the Human Enterovirus species A, family Picornaviridae.
- Trial name
- NCT01391494
- Testing
- 160Eu/0.5ml in adults, 320Eu/0.5ml in adults, 640Eu/0.5ml in adults
- Where
- China
- Volunteers
- 288 people, healthy volunteers welcome
- Sponsor
- Institute of Medical Biology, Chinese Academy of Medical Sciences
Enterovirus Infections
A Study to Evaluate the Efficacy, Immunogenicity and Safety of an EV71 Vaccine in Healthy Infants and Children
The objectives of this study are to evaluate the EV71vaccine efficacy, immune response and safety profiles after two injections of the cell culture-based inactivated EV71 vaccine with adjuvant Al(OH)3 administrated in pediatric…
- Trial name
- NCT05099029
- Testing
- EV71 vaccine
- Where
- 9 sites in Taiwan, Vietnam
- Volunteers
- 3,982 people, healthy volunteers welcome
- Sponsor
- Enimmune Corporation
Hand, Foot and Mouth Disease
Immunogenicity and Safety of Three Consecutive Lots of a New Inactivated Enterovirus Type 71 (EV71) Vaccine
The purpose of this study is to evaluate the immunogenicity and safety of three consecutive lots of EV71 Vaccines in healthy infants volunteers aged from 6 months to 5 years old.
- Trial name
- NCT01636245
- Testing
- three consecutive lots of EV71 vaccine
- Where
- China
- Volunteers
- 1,400 people, healthy volunteers welcome
- Sponsor
- Sinovac Biotech Co., Ltd
Enterovirus 71 Human
A Clinical Study for Inactivated Vaccine Against EV71
This study aims to evaluate the safety, reactogenicity and immunogenicity of EV71 vaccine in health children and infants aged from 2 months to <12yrs.
- Trial name
- EV71 (NCT02200237)
- Testing
- EV71 with adjuvant aluminium phosphate
- Where
- 4 sites in Taiwan
- Volunteers
- 366 people, healthy volunteers welcome
- Sponsor
- Medigen Vaccine Biologics Corp.
Enterovirus 71 Inactivated Vaccine
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
The purpose of this study is to assess the immunogenicity and safety of EV71 vaccine (Envacgen®) in Children Aged 6 to <10 Years compared to Children Aged 2 to <6 Years.
- Trial name
- NCT07178522
- Testing
- Envacgen®
- Where
- 3 sites in Taiwan
- Volunteers
- 379 people, healthy volunteers welcome
- Sponsor
- Medigen Vaccine Biologics Corp.
Hand, Foot and Mouth Disease (HFMD)
The Phase IVb of Inactivated Enterovirus 71 Vaccine (Human Diploid Cell, KMB-17) in Chinese Children
Enterovirus 71 (EV71), a major pathogen causing hand-foot-and-mouth disease (HFMD) worldwide, is a member of the Human Enterovirus species A, family Picornaviridae.
- Trial name
- NCT03001986
- Testing
- inactivated EV71 vaccine (KMB-17 cells)
- Where
- China
- Volunteers
- 40,724 people, healthy volunteers welcome
- Sponsor
- Institute of Medical Biology, Chinese Academy of Medical Sciences