Clinical trials: Hand, Foot and Mouth Disease (HFMD)
Hand, Foot and Mouth Disease, Herpangina
A Clinical Trial to Assess the Efficacy and Safety of an Inactivated Vaccine (Vero Cell) Against EV71 in Chinese Children Aged 6-35 Months
Since its discovery in 1969, enterovirus 71 (EV71) has been recognised as a frequent cause of epidemics of hand-foot-mouth disease (HFMD) associated with severe neurological sequelae in a small proportion of cases.
- Conditions
- Hand, Foot and Mouth Disease, Herpangina, Other EV71-associated Diseases
- Trial name
- NCT01508247
- Testing
- inactivated vaccine (Vero Cell) against EV71
- Where
- 4 sites in China
- Volunteers
- 10,245 people
- Sponsor
- Jiangsu Province Centers for Disease Control and Prevention
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
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
Hand, Foot and Mouth Disease
A Clinical Trial for Inactivated Vaccine(Vero Cell) Against EV71 in Chinese Healthy Young Adults and Children
Hand, foot, and mouth disease (HFMD) is a common viral illness in infants and children caused by viruses that belong to the enterovirus genus of the picornavirus family.
- Trial name
- NCT01267903
- Testing
- vaccine against EV71 of 320U/0.5ml, vaccine against EV71 of 640U/0.5ml, vaccine against EV71 of 160U/0.5ml
- Volunteers
- 100 people
- Sponsor
- Jiangsu Province Centers for Disease Control and Prevention
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
Hand Foot & Mouth Disease
Safety & Immunogenicity of Enterovirus Type 71 Vaccine in Healthy Adults and Children 6-71months
1. Burden: Hand-foot-and-mouth disease (HFMD) characterized by skin rash in extremities, mouth ulcer and fever among <5 years children.Primarily caused by Enterovirus- predominantly human Enterovirus (EV) 71 and Coxsackie virus…
- Trial name
- NCT04467541
- Testing
- Inactivated Enterovirus Type 71 (EV71) Vaccine (Vero Cell)
- Where
- Bangladesh
- Volunteers
- 430 people, healthy volunteers welcome
- Sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
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
Study to Evaluate the Tolerance and Pharmacokinetics of Suramin Sodium
This is a randomized, double-blind, placebo-controlled, single-dose with three incremental doses, Phase 1 study to evaluate the tolerance and pharmacokinetics of suramin sodium for injection in Chinese healthy adults.
- Trial name
- NCT03804749
- Testing
- suramin sodium
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- First Affiliated Hospital of Zhejiang University
Hand, Foot and Mouth Disease, Herpangina
Surveillance of HFMD in Pediatric Outpatients
The aims of this prospective multicentric study is to determine the types of enteroviruses (EVs) responsible for hand, foot and mouth disease (HFMD) or herpangina in children seen within an ambulatory setting : to detect an…
- Conditions
- Hand, Foot and Mouth Disease, Herpangina, Enterovirus Infections
- Trial name
- PMB (NCT06263439)
- Testing
- Throat/buccal swab sample
- Where
- France
- Volunteers
- 3,000 people
- Sponsor
- University Hospital, Clermont-Ferrand
Hand, Foot and Mouth Disease (HFMD)
The Phase IVd of Inactivated Enterovirus 71 Vaccine
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
- NCT03296410
- Testing
- EV71 and two measles attenuated live vaccine, EV71 and attenuated Japanese encephalitis vaccine, two measles attenuated live vaccine
- Where
- China
- Volunteers
- 1,220 people, healthy volunteers welcome
- Sponsor
- Chinese Academy of Medical Sciences
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
Active Case Finding of Clinical Hand Foot Mouth Disease in Children Aged 6 Months Old to 18 Years Old in Indonesia
An observational study of active case surveillance to identify the pathogens of clinically diagnosed HFMD cases aged 6 months to 18 years old recruited from puskesmas and hospitals in Indonesia.
- Trial name
- NCT06251219
- Testing
- PCR
- Volunteers
- 100 people
- 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
Hand, Foot and Mouth Disease
Safety and Immunogenicity of CJ-40010 in Healthy Subjects
This study aims to evaluate the safety and immunogenicity of CJ-40010 after administration in healthy subjects
- Trial name
- NCT04182932
- Testing
- CJ-40010 EV71 vaccine A dose, CJ-40010 EV71 vaccine B dose, CJ-40010 CVA16 vaccine C dose
- Where
- South Korea
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- HK inno.N Corporation
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-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
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, Enterovirus Infections
A Clinical Trial for Inactivated Vaccine (Vero Cell) Against EV71 in Chinese Children and Infants
Hand, foot, and mouth disease (HFMD) is a common viral illness in infants and children caused by viruses that belong to the enterovirus genus of the picornavirus family.
- Trial name
- NCT01313715
- Testing
- 160U /0.5ml, 320U /0.5ml, 640U /0.5ml
- Where
- China
- Volunteers
- 360 people
- Sponsor
- Jiangsu Province Centers for Disease Control and Prevention
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
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.