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（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
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
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
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-mouth Disease, Infection; Viral, Enterovirus
Safety of an Inactivated Enterovirus Type 71 Vaccines in Healthy Children
A Phase I clinical trialto evaluate the safety of an Inactivated Enterovirus Type 71 Vaccine in healthy children (3-11y) and infants (6-35m).
- Trial name
- NCT01273246
- Testing
- 100U inactivated Enterovirus Type 71 Vaccine, 200U inactivated Enterovirus Type 71 Vaccine, 400U inactivated Enterovirus Type 71 Vaccine
- Where
- China
- Volunteers
- 132 people, healthy volunteers welcome
- Sponsor
- Sinovac Biotech Co., Ltd
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.
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
Clinical Trial of Enterovirus 71（EV71） Inactivated Vaccine in Children Aged 36-71 Months
The purpose of this study is to evaluate the non-inferiority of experimental EV71 vaccine compared to the control EV71 vaccine in children aged 36-71 months, to evaluate the non-inferiority of EV71 vaccine used in children aged…
- Trial name
- NCT03909074
- Testing
- 36-71 months old children-experimental EV71 vaccine., 36-71 months old children-control EV71 vaccine., 6-35 months old children-experimental EV71 vaccine.
- Where
- China
- Volunteers
- 900 people, healthy volunteers welcome
- Sponsor
- Sinovac Biotech Co., Ltd
Infection; Viral, Enterovirus
Safety of an Inactivated Enterovirus Type 71 Vaccine in Healthy Adults
A blind, randomized and placebo-controlled clinical trial with Inactivated Enterovirus Type 71 Vaccines in healthy adults
- Trial name
- NCT01273233
- Testing
- Inactivated Enterovirus Type 71 Vaccine
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Sinovac Biotech Co., Ltd
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