Clinical trials: Enterovirus 71 Infection
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
Hand, Foot and Mouth Disease
Immunogenicity of the Inactivated EV71 Vaccine Combined With Hepatitis B and Group A Meningococcal Vaccine
The main purpose of this study is to evaluate the immunogenicity and safety of inactivated enterovirus type 71 vaccine combined with recombinant hepatitis B vaccine or Group a meningococcal polysaccharide vaccine.
- Trial name
- NCT06209398
- Testing
- Enterovirus Type 71 Vaccine, inactivated ( Human Diploid Cell ), Recombinant Hepatitis B Vaccine, Group A meningococcal polysaccharide vaccine
- Where
- China
- Volunteers
- 510 people, healthy volunteers welcome
- Sponsor
- Jiangsu Province Centers for Disease Control and Prevention
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
Safety of Inactivated EV71 Vaccine, Immunization of Inactivated EV71 Vaccine
The Phase IVa of Inactivated Enterovirus 71 Vaccine (Human Diploid Cell, KMB-17)
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
- NCT02999828
- Testing
- inactivated EV71 vaccine (KMB-17)
- Where
- China
- Volunteers
- 20,770 people, healthy volunteers welcome
- Sponsor
- Chinese Academy of Medical Sciences
Enterovirus 71 Human
Long-Term Immunogenicity of Envacgen® in Children
This study is designed to evaluate the long-term antibody titers of Envacgen® approximately 6 years after the first vaccination dose in participants who were aged 2 months to <6 years at the time of enrollment in the CT-EV-31s…
- Trial name
- NCT07568522
- Testing
- EV71 vaccine
- Where
- 4 sites in Taiwan
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- Medigen Vaccine Biologics Corp.
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
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
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 (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
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.
Enterovirus 71 Human
Long-Term Immunogenicity Study of Inactivated EV71 Vaccine in Children
This study is designed to evaluate the long-term antibody titers of EV71 vaccine 4 and 5 years after first dose vaccination for subjects at the age of 2 to < 6 years , and 3 to 5 years after first dose vaccination for subjects at…
- Trial name
- NCT04072276
- Testing
- EV71 vaccine
- Where
- 4 sites in Taiwan
- Volunteers
- 227 people, healthy volunteers welcome
- Sponsor
- Medigen Vaccine Biologics Corp.
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
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
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
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
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
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
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(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
Phase IV Clinical Trial, Immunogenicity and Safety of EV71 Vaccine
The purpose of this study is to evaluate the immunogenicity and safety of EV71 vaccine in infants aged 6 to 35 months old, by detecting the dynamic changes of neutralizing antibody at different time after vaccination
- Trial name
- NCT03278132
- Testing
- EV71 vaccine
- Where
- China
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Sinovac Biotech Co., Ltd