Clinical trials: Enterovirus 71 Infection
Hand, Foot, and Mouth Disease (HFMD), Enterovirus 71 Infection
Bridging Clinical Trial of EV71 Vaccine in Vietnamese Children
The purpose of this study is to evaluate the immunogenicity and safety of an inactivated Enterovirus Type 71 (EV71) vaccine, manufactured by Sinovac, in healthy Vietnamese children aged 6 to 71 months.
- Trial name
- NCT07793175
- Testing
- EV71 vaccine
- Where
- Vietnam
- Volunteers
- 320 people, healthy volunteers welcome
- Sponsor
- Sinovac Biotech Co., Ltd
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
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
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
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, 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(HFMD), Herpangina
Protective Efficacy , Immunogenicity and Safety of the Tetravalent Inactivated Enterovirus Vaccine (Vero Cell).
This multicenter, randomized, double-blind, placebo-controlled phase IIIa clinical trial aims to evaluate the protective efficacy , immunogenicity and safety of the Tetravalent Inactivated Enterovirus Vaccine (Vero Cell) in…
- Trial name
- NCT07611513
- Testing
- Tetravalent Inactivated Enterovirus Vaccine (Vero Cell)
- Where
- 5 sites in China
- Volunteers
- 6,000 people, healthy volunteers welcome
- Sponsor
- Sinovac Biotech Co., Ltd
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
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, 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
Lot-to-lot Consistency Study of Three Commercial Batches of Enterovirus 71 Vaccine
This study is a randomized, blinded study to evaluate the lot-to-lot consistency of immunogenicity, safety, and immune persistence of three consecutive manufacturing lots of EV71 vaccine, in 1500 children aged 6-35 months.
- Trial name
- NCT06146088
- Testing
- EV71 Vaccine
- Where
- 4 sites in China
- Volunteers
- 1,500 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
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
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
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
An Efficacy Trial in Inactivated Enterovirus Type 71 (EV71) Vaccine
The purpose of this study is to evaluate the 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 6 to 35months old.
- Trial name
- NCT01507857
- Testing
- 400U /0.5ml EV71 vaccine
- Where
- 3 sites in China
- Volunteers
- 10,077 people, healthy volunteers welcome
- Sponsor
- Sinovac Biotech Co., Ltd
Hand, Foot and Mouth Disease
Five-year Immune Persistence Study of Inactivated Enterovirus Type 71 (EV71) Vaccine
The purpose of this study is to evaluate the 5-year Immune Persistence of Inactivated Enterovirus Type 71 (EV71) Vaccine manufactured by Sinovac (Beijing) Biotech Co., Ltd.
- Trial name
- NCT03281174
- Where
- China
- Volunteers
- 343 people, healthy volunteers welcome
- Sponsor
- Sinovac Biotech 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
Enterovirus 71 Inactivated Vaccine, HFMD
Clinical Study on Combined Immune Effect of EV71 Inactivated Vaccine
Background: To prevent and control the epidemic of HFMD and related diseases caused by EV71 infection, the development of EV71 vaccine has been developed in many countries or regions.
- Trial name
- NCT03519568
- Testing
- EV71 (inoculation vaccine)
- Where
- China
- Volunteers
- 1,944 people, healthy volunteers welcome
- Sponsor
- Shandong Province Centers for Disease Control and Prevention
Enterovirus 71 Infection
A Study to Evaluate the Efficacy, Safety, and Immunogenicity of an EV71 Vaccine
Subjects will receive the first IM injection of study vaccine on Day 1 and will receive a second dose 56 days later. A booster vaccine will be given 365 days after the first dose in subjects 2 months to < 2 years of age.
- Trial name
- NCT03865238
- Testing
- EV71vac
- Where
- 6 sites in Taiwan, Vietnam
- Volunteers
- 3,061 people, healthy volunteers welcome
- Sponsor
- Medigen Vaccine Biologics Corp.