Clinical trials: Enterovirus 71 Infection
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 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
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
Safety and Immunogenicity Study of an Inactivated Vaccine Against Hand, Foot and Mouth Disease Caused by Enterovirus 71
The purpose of this study is to evaluate the safety and immune response of an inactivated vaccine to prevent hand, foot and mouth disease (HFMD) caused by Enterovirus 71 (EV71).
- Trial name
- NCT01376479
- Testing
- INV21 Low Dose, INV21 High Dose
- Where
- Singapore
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Inviragen Inc.
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
Hand, Foot and Mouth Disease
Safety and Immunogenicity of Concomitant Administration of EV71 Vaccine With EPI Vaccines
The purpose of this study is to evaluate the safety and immunogenicity of concomitant administration of EV71 vaccine with recombinant hepatitis B vaccine/Group A meningococcal polysaccharide vaccine.
- Trial name
- NCT03274102
- Testing
- Concomitant administration of EV71 vaccine with EPI vaccines, Single injection of EPI vaccine, EV71 Vaccine only
- Where
- China
- Volunteers
- 780 people, healthy volunteers welcome
- Sponsor
- Sinovac Biotech Co., Ltd
Hand, Foot, and Mouth Disease, Hand, Foot, and Mouth Disease (HFMD)
Study on the Persistence of Immunity Following EV71 Vaccination
This is a thirteen-year follow-up study conducted as an extension of a Phase III clinical trial. In this study, a sub-cohort of volunteers who was eligible for enrollment and randomly administrated either 2 dose EV71 vaccine or…
- Trial name
- NCT07144202
- Where
- 4 sites in China
- Volunteers
- 270 people, healthy volunteers welcome
- Sponsor
- Institute of Medical Biology, Chinese Academy of Medical Sciences
Hand, Foot and Mouth Disease
Immunity and Safety of Inactivated Enterovirus 71 Vaccine Post-marketing Among Children Aged 6-35 Months in China
This study evaluates three batches consistency, immunity duration and safety of inactivated Enterovirus 71(EV-A71) vaccine(vero cell) post-marketing among children aged 6-35months in China.3000 subjects will be recruited in this…
- Trial name
- NCT03893747
- Testing
- The first batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor, The second batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor, The third batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor
- Where
- China
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- Jiangsu Province Centers for Disease Control and Prevention
Hand, Foot and Mouth Disease (HFMD)
The Phase IVc of Inactivated Enterovirus 71 Vaccine (Human Diploid Cell)
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
- NCT03240744
- Testing
- Inactivated EV71 vaccine (human diploid cell, KMB-17)
- Where
- China
- Volunteers
- 800 people, healthy volunteers welcome
- Sponsor
- Chinese Academy of Medical Sciences
Enterovirus 71 Vaccine
Safety Study of Enterovirus 71 Vaccine in Children Aged 6-35 Months Old
This phase IV clinical study evaluates the safety of enterovirus 71 vaccine in children aged 6-35 months old by the method of both passive and active surveillance.
- Trial name
- NCT02806531
- Testing
- two doses enterovirus 71 vaccine
- Volunteers
- 20,000 people, healthy volunteers welcome
- Sponsor
- Beijing Chaoyang District Centre for Disease Control and Prevention
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
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
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
Hand, Foot and Mouth Disease
An Immunity Persistence Study of Enterovirus 71 Inactivated Vaccine (Vero Cell)
This is an open，observational and follow-up clinical trial based on the clinical trial of EV71 vaccine extended age group.The purpose of this study is to evaluate the immunity persistence of EV71 vaccine developed by Sinovac…
- Trial name
- NCT05397587
- Testing
- Experimental Vaccine, Control Vaccine
- Where
- China
- Volunteers
- 474 people, healthy volunteers welcome
- Sponsor
- Sinovac Biotech Co., Ltd
Enterovirus 71, Host Genetics, Social, Behavior, Environmental Factors
Children's Susceptibility to Enterovirus 71 in Different Areas of Taiwan
EV71 has caused large epidemics with lots of fatal cases and cases with sequelae. However, the clinical syndromes and severity of the same EV71 strain are very diverse, ranging from asymptomatic (71%) to fatal (0.05%) disease…
- Trial name
- DMR100-IRB-010 (NCT01311921)
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- China Medical University Hospital
Hand, Foot and Mouth Disease
A Serosurvey Study of Hand, Foot, and Mouth Disease in Indonesia
This study is a sero-survey study of infants aged 6 months to 71 months in Bandung City and West Bandung District. As initial data to find out how many children have been exposed to human enterovirus type 71 (HEV-71) which causes…
- Trial name
- NCT05637229
- Where
- 2 sites in Indonesia
- Volunteers
- 600 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.
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
Enterovirus Infections
Extension Study of Protocol EV-BR1701 Group B1
The main study was a randomized, multi-nation, multi-centered, double-blinded, phase III study on subjects aged 2 months to <6 years old (<72 months). Two parts were conducted in Taiwan (Group A) and Vietnam (Group B).
- Trial name
- NCT07630493
- Where
- Vietnam
- Volunteers
- 126 people
- Sponsor
- Enimmune Corporation
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