Clinical trials: HFMD
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
Effectiveness and Safety of Chinese Medicine to Treat Hand, Foot, and Mouth Disease
The study is aimed to evaluate the effectiveness and safety of Xiyanping injection,a traditional Chinese medicine (TCM), in the treatment of severe type of hand, foot, and mouth disease (HFMD).
- Trial name
- NCT01554930
- Testing
- Western therapy (mannitol, methylprednisolone, immunoglobulin, febrifuge), Xiyanping injection plus western therapy
- Where
- 3 sites in China
- Volunteers
- 230 people
- Sponsor
- Jiangxi Qingfeng Pharmaceutical 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
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
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 (HFMD), Herpangina
Tolerability, Safety, and Immunogenicity of Tetravalent Inactivated Enterovirus Vaccine (Vero Cell).
The trial aims to assess the tolerability, safety, and immunogenicity of the tetravalent inactivated enterovirus vaccine in adults and children aged 6 months to 12 years.
- Trial name
- NCT06754384
- Testing
- Low-dose of tetravalent inactivated enterovirus vaccine (Vero cell), Medium-dose tetravalent inactivated enterovirus vaccine (Vero cell), High-dose tetravalent inactivated enterovirus vaccine (Vero cell) )
- Where
- China
- Volunteers
- 552 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
Enterovirus Infections
A Study to Evaluate the Immunogenicity and Safety of EV71 Vaccine in Pediatric Subjects
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 Al(OH)3 at 0.5-μg and 1-μg dose in children aged 3 to 6 years old and 2…
- Trial name
- NCT03268083
- Testing
- EV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AI(OH)3] per dose), EV71 vaccine ([1 μg total protein + adjuvant 150 μg AI(OH)3] per dose), EV71 vaccine ([1 μg total protein ] per dose)
- Where
- 4 sites in Taiwan
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Enimmune Corporation
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
Hand, Foot and Mouth Disease, Herpangina
Inactivated Bivalent Enterovirus Vaccine (Vero Cell) Phase I/II Clinical Trial
The Phase I clinical trial is divided into two parts. The first part uses an open-label design, while the second part uses a randomized, double-blind, and controlled design.
- Trial name
- NCT06063057
- Testing
- low dose Bivalent Enterovirus Vaccine (Vero Cell), Inactivated, medium dose Bivalent Enterovirus Vaccine (Vero Cell), Inactivated, high dose Bivalent Enterovirus Vaccine (Vero Cell), Inactivated
- Where
- China
- Volunteers
- 744 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
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
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
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
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
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
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
Safety Observation of Enterovirus 71 Inactivated Vaccine (Vero Cell) Combined Immunization in Shanghai
This study is an open clinical trial of the EV71 vaccine (Vero cell), Inactivated manufactured by Sinovac Research \& Development Co.,Ltd.The purpose of this study is to evaluate the safety of EV71 vaccine (Vero cell)…
- Trial name
- NCT05166044
- Testing
- EV71 Inactivated Vaccine
- Where
- 6 sites in China
- Volunteers
- 12,500 people, healthy volunteers welcome
- Sponsor
- Sinovac Biotech Co., Ltd