| 1 |
NCT01940250 |
Completed |
Magnesium Sulphate for Severe Hand, Foot and Mouth Disease in Vietnam |
- Hand, Foot and Mouth Disease
|
- Drug: Magnesium Sulphate
- Drug: Sterile water
|
Interventional
|
Phase 2 |
- Oxford University Clinical Research Unit, Vietnam
- Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
- Children's Hospital Number 1, Ho Chi Minh City, Vietnam
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Number of patients who experience at least one of the clinical events listed below (composite endpoint)
- Death
- Blood pressure criteria necessitating addition of milrinone following Vietnam Ministry of Health guidelines for the treatment of hand, foot and mouth disease
- (and 7 more...)
|
26 |
All |
6 Months to 15 Years (Child) |
NCT01940250 |
02EI |
|
April 21, 2014 |
June 30, 2016 |
December 28, 2016 |
September 12, 2013 |
March 7, 2017 |
|
- Children's Hospital 1
Ho Chi Minh City, Vietnam - Hospital for Tropical Diseases
Ho CHi Minh City, Vietnam
|
|
| 2 |
NCT02066714 |
Completed |
Neurodevelopment Outcomes Following Severe Hand Foot and Mouth Disease in Vietnam |
- Hand Foot and Mouth Disease
|
|
Observational
|
|
- Oxford University Clinical Research Unit, Vietnam
- Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
- Children's Hospital Number 1, Ho Chi Minh City, Vietnam
- Preventative Medical Centre, District 8, Ho Chi Minh City, Vietnam
|
Other |
- Observational Model: Case Control
- Time Perspective: Prospective
|
- Cognitive, language and motor development
- Neurological status
|
243 |
All |
up to 4 Years (Child) |
NCT02066714 |
08RS |
08RS |
June 2013 |
December 2014 |
August 2016 |
February 19, 2014 |
October 4, 2016 |
|
- Hospital of Tropical Diseases
Ho Chi Minh City, Vietnam
|
|
| 3 |
NCT01145664 |
Unknown † |
A Multi-Center Clinical Trial To Evaluate Chinese Herbal Medicines in the Treatment of Severe Hand-foot-mouth Disease |
- Hand, Foot and Mouth Disease
|
- Drug: Herbal concentrate-granules plus western therapy
- Drug: Reduning Injection plus western therapy
- Drug: Western therapy
|
Interventional
|
Not Applicable |
- Beijing YouAn Hospital
- State Administration of Traditional Chinese Medicine of the People's Republic of China
- China Academy of Chinese Medical Sciences
- Beijing University of Chinese Medicine
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- incidence of complications
- incidence of critically ill patients
- case fatality rate
- (and 5 more...)
|
390 |
All |
1 Year to 13 Years (Child) |
NCT01145664 |
200907001-3 |
|
May 2010 |
August 2010 |
|
June 17, 2010 |
June 17, 2010 |
|
- Guangzhou Women and Children Hospital
Guangzhou, Guangdong, China - The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China - Kaifeng Municipal Children's Hospital
Kaifeng, Henan, China - (and 3 more...)
|
|
| 4 |
NCT01376479 |
Completed |
Safety and Immunogenicity Study of an Inactivated Vaccine Against Hand, Foot and Mouth Disease Caused by Enterovirus 71 |
- Hand, Foot and Mouth Disease
|
- Biological: INV21 Low Dose
- Biological: INV21 High Dose
- Biological: Placebo
|
Interventional
|
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Frequency of systemic adverse events and local reactions in healthy adults following two doses of INV21 given 28 days apart
- Immunogenicity of INV21 vaccine in healthy adults following two doses given 28 days apart
|
36 |
All |
21 Years to 45 Years (Adult) |
NCT01376479 |
INV-EVR-101 |
|
August 2011 |
November 2011 |
April 2012 |
June 20, 2011 |
May 6, 2015 |
|
- Investigational Medicine Unit, National University Hospital
Singapore, Singapore
|
|
| 5 |
NCT01769794 |
Completed |
Chinese Medicinal Treatment on Mild Hand, Foot, and Mouth Disease: Multicenter, Prospective, Randomized Double-blind, Placebo-controlled Study |
- Hand, Foot and Mouth Disease
|
- Drug: Western therapy
- Drug: JET
- Drug: Placebo(for JET)
|
Interventional
|
Not Applicable |
- China Academy of Chinese Medical Sciences
- Chengdu University of Traditional Chinese Medicine
- Beijing Children's Hospital
- (and 4 more...)
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- The time of body temperature going back to normal
- Healing time of skin or oral mucosa lesions symptom
- Score of skin or oral mucosa lesions symptom during the study period time
- (and 2 more...)
|
288 |
All |
1 Year to 13 Years (Child) |
NCT01769794 |
ChinaACMS-HFMD |
|
June 2011 |
October 2011 |
October 2011 |
January 17, 2013 |
January 17, 2013 |
|
- Tangshan infectious disease hospital
Tangshan, Hebei, China - Affiliated Hospital of Chengdu university of Traditional Chinese Medicine
Chengdu, Sichuan, China - Beijing children's hospital
Beijing, China - Tianjin infectious disease hospital
Tianjin, China
|
|
| 6 |
NCT01182532 |
Completed |
A Clinical Trial to Evaluate the Effectiveness and Safety of Chinese Medicine in the Treatment of Mild Type of Hand, Foot, and Mouth Disease |
- Hand, Foot and Mouth Disease
|
- Other: Western therapy
- Drug: TCM Syndrome Differentiation and Treatment
- Other: Western therapy plus TCM treatment
|
Interventional
|
Not Applicable |
- The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
- Beijing University of Chinese Medicine
- China Academy of Chinese Medical Sciences
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- time to onset
- time of body temperature going back to normal
- time of symptom disappearance
- (and 4 more...)
|
3000 |
All |
1 Year to 14 Years (Child) |
NCT01182532 |
200907001-3 |
|
May 2010 |
October 2011 |
December 2011 |
August 17, 2010 |
July 23, 2012 |
|
- Anhui Provincial Children's Hospital
Hefei, Anhui, China - The First Affiliated Hospital of Anhui College of Traditional Chinese Medicine
Hefei, Anhui, China - Beijing Ditan Hospital
Beijing, Beijing, China - (and 18 more...)
|
|
| 7 |
NCT01175915 |
Unknown † |
A Clinical Trial To Evaluate Reduning Injection in the Treatment of Mild Type of Hand, Foot, and Mouth Disease |
- Hand, Foot and Mouth Disease
|
- Other: Western therapy
- Other: Reduning Injection
- Other: Reduning Injection plus western therapy
|
Interventional
|
Not Applicable |
- Jiangsu Kanion Pharmaceutical Co., Ltd
- Beijing University of Chinese Medicine
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- time of bringing down the fever
- time of body temperature going back to normal
- time of symptom disappearance
- (and 4 more...)
|
360 |
All |
1 Year to 13 Years (Child) |
NCT01175915 |
200907001-3-1 |
|
May 2010 |
August 2010 |
August 2010 |
August 5, 2010 |
August 5, 2010 |
|
- An'Hui Provincial Children's Hospital
Hefei, Anhui, China - Fujian Provincial Quanzhou City Children's Hospital
Quanzhou, Fujian, China - The Fifth Hospital of Shijiazhuang City
Shijiazhuang, Hebei, China - (and 3 more...)
|
|
| 8 |
NCT01182025 |
Unknown † |
A Clinical Trial to Evaluate the Effectiveness and Safety of Xiyanping Injection in the Treatment of Mild Type of Hand, Foot, and Mouth Disease |
- Hand, Foot and Mouth Disease
|
- Other: Western therapy
- Drug: Xiyanping Injection
- Drug: Xiyanping Injection with western medicine
|
Interventional
|
Not Applicable |
- The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
- Beijing University of Chinese Medicine
- China Academy of Chinese Medical Sciences
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- time of bringing down the fever
- time of body temperature going back to normal
- time of symptom disappearance
- (and 4 more...)
|
360 |
All |
1 Year to 14 Years (Child) |
NCT01182025 |
200907001-4 |
|
June 2010 |
May 2011 |
December 2011 |
August 16, 2010 |
August 17, 2010 |
|
- Affiliated Hospital of Guilin Medical College
Guilin, Guangxi, China - Liuzhou Worker's Hospital
Liuzhou, Guangxi, China - Liuzhou People's Hospital
Liuzhou, Guangxi, China - (and 2 more...)
|
|
| 9 |
NCT03001986 |
Active, not recruiting |
The Phase IVb of Inactivated Enterovirus 71 Vaccine (Human Diploid Cell, KMB-17) in Chinese Children |
- Hand, Foot and Mouth Disease (HFMD)
|
- Biological: inactivated EV71 vaccine (KMB-17 cells)
|
Interventional
|
Phase 4 |
- Chinese Academy of Medical Sciences
- Hubei Province Centers for Disease Control and Prevention
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- The effectiveness of inactivated EV71 vaccine in preventing hand-foot-and-mouth disease (HFMD) caused by Enterovirus 71 (EV71) in large scale population of Chinese children (from 6 to 71 months old) in Hubei Province, China.
- Incidence of treatment adverse events
|
39189 |
All |
6 Months to 71 Months (Child) |
NCT03001986 |
2016-012-03 |
|
September 2016 |
March 2018 |
March 2018 |
December 23, 2016 |
March 1, 2018 |
|
- Hubei Province Center for Diseases Control and Prevention
Wuhan, Hubei, China
|
|
| 10 |
NCT02001233 |
Completed |
A Follow-up Study for a Phase III, Efficacy Trial in Inactivated Enterovirus Type 71 (EV71) Vaccine |
- Hand, Foot and Mouth Disease
|
|
Observational
|
|
|
Industry |
- Observational Model: Case Control
- Time Perspective: Prospective
|
- The incidence rate of Hand, Foot and Mouth disease caused by EV71 within the second year observation period after the second vaccination
- The GMT of anti-EV71 antibodies in serum two years after second vaccination
- Frequency of serious adverse events (SAEs) with the second year after the second vaccination
|
10077 |
All |
6 Months to 35 Months (Child) |
NCT02001233 |
PRO-EV71-3003 |
|
March 2013 |
March 2014 |
October 2014 |
December 4, 2013 |
May 22, 2015 |
|
- Ganyu
Lianyungang, Jiangsu, China - Taixing
Taizhou, Jiangsu, China - Sheyang
Yancheng, Jiangsu, China
|
|
| 11 |
NCT01507857 |
Completed |
An Efficacy Trial in Inactivated Enterovirus Type 71 (EV71) Vaccine |
- Hand, Foot and Mouth Disease
|
- Biological: 400U /0.5ml EV71 vaccine
- Biological: 0/0.5ml placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Prevention
|
- The incidence rate of Hand, Foot and Mouth disease caused by EV71 within one year observation period after the second vaccination
- The GMT of anti-EV71 antibodies in serum after second vaccination
- The GMT of anti-EV71 antibodies in serum 7 and 13 months after second vaccination
- (and 2 more...)
|
10077 |
All |
6 Months to 35 Months (Child) |
NCT01507857 |
PRO-EV71-3001 |
|
January 2012 |
March 2013 |
March 2013 |
January 11, 2012 |
November 28, 2013 |
|
- Ganyu
Lianyungang, Jiangsu, China - Taixing
Taizhou, Jiangsu, China - Sheyang CDC
Yancheng, Jiangsu, China
|
|
| 12 |
NCT03296410 |
Enrolling by invitation |
The Phase IVd of Inactivated Enterovirus 71 Vaccine |
- Hand, Foot and Mouth Disease (HFMD)
|
- Biological: EV71 and two measles attenuated live vaccine
- Biological: EV71 and attenuated Japanese encephalitis vaccine
- Biological: two measles attenuated live vaccine
- (and 2 more...)
|
Interventional
|
Phase 4 |
- Chinese Academy of Medical Sciences
- Guangdong Center for Disease Prevention and Control
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Evaluate the seropositive rate of anti-EV71 antibodies in serum of children before first vaccination
- Evaluate the seropositive rate of anti-EBV antibodies in serum of children before first vaccination
- Evaluate the seropositive rate of anti-measles virus antibodies in serum of children before first vaccination
- (and 11 more...)
|
1220 |
All |
8 Months to 9 Months (Child) |
NCT03296410 |
20170710 |
|
September 14, 2017 |
September 2, 2019 |
September 2, 2019 |
September 28, 2017 |
September 28, 2017 |
|
- Guangdong Province Center for Diseases Control and Prevention
Guangzhou, Guangdong, China
|
|
| 13 |
NCT03240744 |
Active, not recruiting |
The Phase IVc of Inactivated Enterovirus 71 Vaccine (Human Diploid Cell) |
- Hand, Foot and Mouth Disease (HFMD)
|
- Biological: Inactivated EV71 vaccine (human diploid cell, KMB-17)
|
Interventional
|
Phase 4 |
- Chinese Academy of Medical Sciences
- Hubei Province Centers for Disease Control and Prevention
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Evaluate the seroconversion rate of anti-EV71 antibodies in serum of children
- Evaluate the antibody titers of anti-EV71 antibodies in serum of children
- Evaluate long-term of the seroconversion rate of anti-EV71 antibodies in serum of children
- Evaluate long-term of the antibody titers of anti-EV71 antibodies in serum of children
|
800 |
All |
6 Months to 71 Months (Child) |
NCT03240744 |
2017-003-02 |
|
June 22, 2017 |
October 2020 |
October 2020 |
August 7, 2017 |
September 6, 2017 |
|
- Hubei Province Center for Diseases Control and Prevention
Wuhan, Hubei, China
|
|
| 14 |
NCT02328651 |
Completed |
Effect of Xiaoer Jiebiao Oral Liquid on Hand-foot-mouth Disease |
|
- Drug: Ribavirin plus Xiao'er jiebiao oral liquid
- Drug: Ribavirin
|
Interventional
|
Phase 4 |
- Children's Hospital of Fudan University
- Weihai Rensheng Pharmacy
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- Time (hours) taken from treatment start till body temperature dropping to normal
- Time (hours) taken from disease onset till body temperature dropping to normal
- Top body temperature at the 24th hour, 48th hour and the 72th hour from treatment starting.
- (and 3 more...)
|
24 |
All |
1 Year to 5 Years (Child) |
NCT02328651 |
XEJB_Ver1.0 |
|
October 2014 |
April 30, 2018 |
May 31, 2018 |
December 31, 2014 |
August 7, 2018 |
|
- Children's Hospital of Fudan University
Shanghai, China
|
|
| 15 |
NCT01267903 |
Completed |
A Clinical Trial for Inactivated Vaccine(Vero Cell) Against EV71 in Chinese Healthy Young Adults and Children |
- Hand, Foot and Mouth Disease
|
- Biological: vaccine against EV71 of 320U/0.5ml
- Biological: vaccine against EV71 of 640U/0.5ml
- Biological: vaccine against EV71 of 160U/0.5ml
|
Interventional
|
Phase 1 |
- Jiangsu Province Centers for Disease Control and Prevention
- Bejing Vigoo Biological Co., LTD
|
Other / Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- to evaluate the safety of EV71 vaccine in Chinese healthy adults and children
- to evaluate the seroconversion rate of Antinuclear antibodies in serum after first vaccination
- to evaluate the seroconversion rate of Antinuclear antibodies in serum after second vaccination
- (and 2 more...)
|
100 |
All |
5 Years to 22 Years (Child, Adult) |
NCT01267903 |
JSVCT003 |
|
January 2011 |
May 2011 |
June 2011 |
December 29, 2010 |
June 10, 2011 |
|
|
|
| 16 |
NCT01512706 |
Completed |
A Phase II, Safety and Efficacy Study of Inactivated EV 71 Vaccine (Human Diploid Cell, KMB-17) in Chinese Infants |
- The Study Focused on the Safety of Inactivated EV71 Vaccine (Human Diploid Cell) Against Hand, Foot and Mouth Disease in Chinese Children and Infants
|
- Biological: 160Eu/0.5ml in infants (6-11 months old)
- Biological: 320Eu/0.5ml in infants (6-11 months old)
- Biological: 640Eu/0.5ml in infants (6-11 months old)
- (and 12 more...)
|
Interventional
|
Phase 2 |
- Chinese Academy of Medical Sciences
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Prevention
|
- Evaluate the safety of Inactivated EV 71 Vaccine (Human Diploid Cell, KMB-17) in Chinese Infants (from 6 to 11 months old)
- Evaluate the safety of Inactivated EV 71 Vaccine (Human Diploid Cell, KMB-17) in Chinese Infants (from 12 to 23 months old)
- Evaluate the safety of Inactivated EV 71 Vaccine (Human Diploid Cell, KMB-17) in Chinese children (from 24 months to 5 years old)
- (and 10 more...)
|
660 |
All |
6 Months to 5 Years (Child) |
NCT01512706 |
EV71-KMB17-II-IMB-CAMS |
|
July 2011 |
January 2012 |
February 2012 |
January 19, 2012 |
April 27, 2012 |
|
- Guangxi Provincial Center for Diseases Control and Prevention
Nanning, Guangxi, China
|
|
| 17 |
NCT01391494 |
Completed |
A Safety Study of Inactivated EV71 Vaccine (Human Diploid Cell, KMB-17) in Chinese Adults, Children and Infants |
- The Study Focused on the Safety of Inactivated EV71 Vaccine (Human Diploid Cell) Against Hand, Foot and Mouth Disease in Chinese Adults, Children and Infants.
|
- Biological: 160Eu/0.5ml in adults
- Biological: 320Eu/0.5ml in adults
- Biological: 640Eu/0.5ml in adults
- (and 12 more...)
|
Interventional
|
Phase 1 |
- Longding Liu
- Guangxi Center for Disease Control and Prevention
- Chinese Academy of Medical Sciences
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Prevention
|
- Evaluate the Safety of Inactivated EV 71 Vaccine (Human Diploid Cell, KMB-17) in Chinese Adults.
- Evaluate the Safety of Inactivated EV 71 Vaccine (Human Diploid Cell, KMB-17) in Chinese Children.
- Evaluate the safety of Inactivated EV 71 Vaccine (Human Diploid Cell, KMB-17) in Chinese Infants.
- (and 8 more...)
|
288 |
All |
6 Months to 49 Years (Child, Adult) |
NCT01391494 |
EV71-KMB17-I-IMB-CAMS |
|
February 2011 |
June 2011 |
June 2011 |
July 12, 2011 |
April 27, 2012 |
|
- Guangxi Provincial Center for Diseases Control and Prevention
Nanning, Guangxi, China
|
|
| 18 |
NCT03804749 |
Recruiting |
Study to Evaluate the Tolerance and Pharmacokinetics of Suramin Sodium |
- Hand, Foot and Mouth Disease
|
- Drug: suramin sodium
- Other: placebo
|
Interventional
|
Phase 1 |
- First Affiliated Hospital of Zhejiang University
- Guangdong Kangda Pharmaceutical Co., Ltd
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Number of subjects with adverse events
- the area under the plasma concentration-time curve (AUC) from time zero to the time of the last measurable concentration (AUC0-t) of suramin sodium
- the AUC from time zero to infinity (AUC0-inf) of suramin sodium
- (and 5 more...)
|
36 |
All |
18 Years to 45 Years (Adult) |
NCT03804749 |
LC00-043 |
|
December 19, 2018 |
December 19, 2019 |
December 19, 2020 |
January 15, 2019 |
January 15, 2019 |
|
- First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China
|
|
| 19 |
NCT03582761 |
Not yet recruiting |
Efficacy Evaluation for Inactivated Vaccine (Vero Cell) Against EV71 |
- Hand, Foot and Mouth Disease
|
|
Interventional
|
Phase 4 |
- Jiangsu Province Centers for Disease Control and Prevention
- Wuhan Institute of Biological Products Co., Ltd
- Shandong Province Centers for Disease Control and Prevention
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- EV71 positive HFMD cases confirmed by PCR detection in hospital.
- Incidence and severity of adverse reactions/adverse events in children aged 6-35 months after EV71 vaccine receiving.
- Incidence of serious adverse events in children aged 6-35 months after EV71 vaccine receiving.
- (and 13 more...)
|
40000 |
All |
6 Months to 35 Months (Child) |
NCT03582761 |
JSVCT048 |
|
August 2018 |
December 2019 |
December 2019 |
July 11, 2018 |
July 11, 2018 |
|
|
|
| 20 |
NCT03278132 |
Completed |
Phase IV Clinical Trial, Immunogenicity and Safety of EV71 Vaccine |
- Hand, Foot and Mouth Disease
|
|
Interventional
|
Phase 4 |
- Sinovac Biotech Co., Ltd
- Zhejiang Provincial Center for Disease Control and Prevention
- Shangyu District Center for Disease Control and Prevention
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- The seroconversion rate of EV71 neutralizing antibody 30 days after the two doses vaccination
- The seroconversion rate of EV71 neutralizing antibody 10, 20 and 30 days after the first dose vaccination
- The seropositive rate of EV71 neutralizing antibody 10, 20, 30, and 60 days after the first dose vaccination
- (and 4 more...)
|
120 |
All |
6 Months to 35 Months (Child) |
NCT03278132 |
PRO-EV71-4011 |
|
July 16, 2017 |
September 15, 2017 |
September 15, 2017 |
September 11, 2017 |
January 1, 2019 |
|
- Shangyu District Center for Disease Control and Prevention
Shaoxing, Zhejiang, China
|
|
| 21 |
NCT03274102 |
Completed |
Safety and Immunogenicity of Concomitant Administration of EV71 Vaccine With EPI Vaccines |
- Hand, Foot and Mouth Disease
|
- Biological: Concomitant administration of EV71 vaccine with EPI vaccines
- Biological: Single injection of EPI vaccine
- Biological: EV71 Vaccine only
|
Interventional
|
Phase 4 |
- Sinovac Biotech Co., Ltd
- Guangdong Provincial Center for Disease Control and Prevention
- Dongguan Municipal Center for Disease Control and Prevention
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- The seropositive rate of EV71 neutralizing antibody, anti-HBs and serum bactericidal antibody 1 month after 2 doses of vaccination
- Incidence of solicited local or systemic adverse events within 7 days after each dose
- Incidence of unsolicited local or systemic adverse events within 30 days after each dose
- (and 3 more...)
|
780 |
All |
6 Months to 6 Months (Child) |
NCT03274102 |
PRO-EV71-4003 |
|
April 22, 2017 |
November 1, 2017 |
November 1, 2017 |
September 6, 2017 |
January 1, 2019 |
|
- Dongguan Municipal Center for Disease Control and Prevention
Dongguan, Guangdong, China
|
|
| 22 |
NCT03281174 |
Completed |
Five-year Immune Persistence Study of Inactivated Enterovirus Type 71 (EV71) Vaccine |
- Hand, Foot and Mouth Disease
|
|
Observational
|
|
|
Industry |
- Observational Model: Other
- Time Perspective: Prospective
|
- The seropositive rate of EV71 neutralizing antibody-1
- The seropositive rate of EV71 neutralizing antibody-2
- The seropositive rate of EV71 neutralizing antibody-3
- The GMT of EV71 neutralizing antibody
|
343 |
All |
6 Months to 35 Months (Child) |
NCT03281174 |
PRO-EV71-4007 |
|
May 20, 2017 |
May 21, 2017 |
May 21, 2017 |
September 13, 2017 |
September 13, 2017 |
|
- Sheyang Center for Disease Control and Prevention
Yancheng, Jiangsu, China
|
|
| 23 |
NCT01636245 |
Completed |
Immunogenicity and Safety of Three Consecutive Lots of a New Inactivated Enterovirus Type 71 (EV71) Vaccine |
- Hand, Foot and Mouth Disease
|
- Biological: three consecutive lots of EV71 vaccine
- Biological: placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Prevention
|
- The GMT of anti-EV71 antibodies in serum 28 days after the two-dose regimen
- Frequency of systemic and local adverse reactions after the first vaccination
- Frequency of systemic and local adverse reactions after the second vaccination
|
1400 |
All |
6 Months to 5 Years (Child) |
NCT01636245 |
PRO-EV71-3002 |
|
July 2012 |
September 2012 |
February 2013 |
July 10, 2012 |
March 15, 2013 |
|
- Jurong
ZhenJiang, Jiangsu, China
|
|
| 24 |
NCT02889497 |
Not yet recruiting |
Safety, Three Batches Consistency and Immunity Duration of the Post-marketing Inactivated Enterovirus Type 71 (EV71) Vaccine in Children Aged 6-71 Months |
- Hand Foot and Mouth Disease
|
- Biological: the first batch vaccine
- Biological: the second batch vaccine
- Biological: the third batch vaccine
|
Interventional
|
Phase 4 |
- Beijing Chaoyang District Centre for Disease Control and Prevention
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Prevention
|
- Evaluate the Rate of Adverse reactions of Post-marketing Inactivated Enterovirus Type 71 (EV71) Vaccine in Children Aged 6-71 Months.
- Evaluate the seroconversion rate of EV71 antibodies in serum after vaccination.
|
20900 |
All |
6 Months to 71 Months (Child) |
NCT02889497 |
cycdc2016-6 |
|
September 2016 |
March 2019 |
September 2019 |
September 5, 2016 |
September 7, 2016 |
|
|
|
| 25 |
NCT01255124 |
Completed |
Study on Dynamic Changes of the Maternal Anti-EV71 and Anti-CVA16 Antibody Levels in Infants and Young Children |
- Hand, Foot and Mouth Disease
- Anti-EV71
- Anti-CVA16
|
|
Observational
|
|
- Jiangsu Province Centers for Disease Control and Prevention
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- dynamic changes of the maternal anti-EV71
- dynamic changes of the maternal anti-CVA16
- incidence of HFMD
|
1297 |
All |
2 Years to 3 Years (Child) |
NCT01255124 |
JSVCT002 |
|
October 2010 |
September 2011 |
September 2011 |
December 7, 2010 |
September 14, 2011 |
|
- Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu, China
|
|
| 26 |
NCT01554930 |
Completed |
Effectiveness and Safety of Chinese Medicine to Treat Hand, Foot, and Mouth Disease |
- Hand, Foot, and Mouth Disease
|
- Drug: Western therapy (mannitol, methylprednisolone, immunoglobulin, febrifuge)
- Drug: Xiyanping injection plus western therapy
|
Interventional
|
Not Applicable |
- Jiangxi Qingfeng Pharmaceutical Co. Ltd.
- China Academy of Chinese Medical Sciences
- Beijing YouAn Hospital
- (and 2 more...)
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- complication rate
- time of body temperature going back to normal
- time of symptom disappearance
- safety outcome
|
230 |
All |
1 Year to 13 Years (Child) |
NCT01554930 |
200907001-3 |
|
May 2010 |
November 2010 |
December 2011 |
March 15, 2012 |
March 15, 2012 |
|
- Liuzhou People's Hospital
Liuzhou, Guangxi, China - Handan Maternal and Child Health Care Hospital
Handan, Hebei, China - Jiangxi Children's Hospital
Nanchang, Jiangxi, China
|
|
| 27 |
NCT01508247 |
Completed |
A Clinical Trial to Assess the Efficacy and Safety of an Inactivated Vaccine (Vero Cell) Against EV71 in Chinese Children Aged 6-35 Months |
- Hand, Foot and Mouth Disease
- Herpangina
- Other EV71-associated Diseases
|
- Biological: inactivated vaccine (Vero Cell) against EV71
- Biological: 0/0.5ml placebo
|
Interventional
|
Phase 3 |
- Jiangsu Province Centers for Disease Control and Prevention
- Bejing Vigoo Biological Co., LTD
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Prevention
|
- the incidence density of the EV71-associated diseases in the vaccine group and placebo group.
- the frequency of all the adverse events in vaccine group and placebo group.
- Seropositive rate of the vaccine group
- (and 6 more...)
|
10245 |
All |
6 Months to 35 Months (Child) |
NCT01508247 |
JSVCT010 |
|
January 2012 |
March 2013 |
March 2013 |
January 11, 2012 |
March 29, 2013 |
|
- Donghai County Center for Disease Control and Prevention
Lianyungang, Jiangsu, China - Pizhou County-Level City Center for Disease Control and Prevention
Xuzhou, Jiangsu, China - Baoying County Center for Disease Control and Prevention
Yangzhou, Jiangsu, China - Chaoyang Distinct Center for Disease Control and Prevention
Beijing, China
|
|
| 28 |
NCT01273246 |
Completed |
Safety of an Inactivated Enterovirus Type 71 Vaccines in Healthy Children |
- Hand-foot-mouth Disease
- Infection; Viral, Enterovirus
|
- Biological: 100U inactivated Enterovirus Type 71 Vaccine
- Biological: 200U inactivated Enterovirus Type 71 Vaccine
- Biological: 400U inactivated Enterovirus Type 71 Vaccine
- Biological: Placebo
|
Interventional
|
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Care Provider)
- Primary Purpose: Prevention
|
- To evaluate the safety of the inactivated Enterovirus Type 71 Vaccine
- To evaluate the immunogenicity of the inactivated Enterovirus Type 71 Vaccine
|
132 |
All |
6 Months to 11 Years (Child) |
NCT01273246 |
EV71-1001-Ib |
|
January 2011 |
June 2011 |
July 2011 |
January 10, 2011 |
July 25, 2011 |
|
- GuangXi Center for Diseases Control and Prevention
Nanning, Guangxi, China
|
|
| 29 |
NCT03241030 |
Enrolling by invitation |
Sucralfate to Improve Oral Intake in Children With Infectious Oral Ulcers: a Randomized, Double-blind, Placebo-Controlled Trial |
- Herpangina
- Gingivostomatitis
- Hand, Foot and Mouth Disease
|
- Drug: Sucralfate
- Other: Placebo
- Drug: Acetaminophen
- Drug: Ibuprofen
|
Interventional
|
Phase 2 |
- University of Texas at Austin
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Supportive Care
|
- Oral Intake in mililiters
- Number of participants that require intravenous fluid administration
- Number of participants that require admission
- Rates of unscheduled visits
|
100 |
All |
6 Months to 5 Years (Child) |
NCT03241030 |
2017-06-0024 |
|
September 12, 2017 |
June 2019 |
June 2019 |
August 7, 2017 |
October 26, 2017 |
|
- Dell Children's Medical Center
Austin, Texas, United States
|
|
| 30 |
NCT01313715 |
Completed |
A Clinical Trial for Inactivated Vaccine (Vero Cell) Against EV71 in Chinese Children and Infants |
- Hand, Foot, and Mouth Disease
- Enterovirus Infections
|
- Biological: 160U /0.5ml
- Biological: 320U /0.5ml
- Biological: 640U /0.5ml
- Biological: 0/0.5ml placebo
|
Interventional
|
Phase 1 |
- Jiangsu Province Centers for Disease Control and Prevention
- Bejing Vigoo Biological Co., LTD
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Prevention
|
- Number of participants with adverse events after first vaccination
- Number of participants with adverse events after second vaccination
- The seroconversion rate of anti-EV71 antibodies in serum after first vaccination
- (and 3 more...)
|
360 |
All |
6 Months to 60 Months (Child) |
NCT01313715 |
JSVCT004 |
|
March 2011 |
June 2011 |
June 2011 |
March 14, 2011 |
January 2, 2012 |
|
- Donghai Center for Diseases Control and Prevention
Lianyungang, Jiangsu, China
|
|
| 31 |
NCT02777411 |
Completed |
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 |
|
- Biological: EV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AIPO4] per dose)
- Biological: EV71 vaccine ([1 μg total protein + adjuvant 150 μg AIPO4] per dose)
- Biological: EV71 vaccine ([2 μg total protein + adjuvant 150 μg AIPO4] per dose)
- (and 2 more...)
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Solicited adverse events
- Unsolicited adverse events
- The occurrence of overall adverse events (AEs) and serious adverse event (SAEs)
- (and 7 more...)
|
122 |
All |
6 Months to 6 Years (Child) |
NCT02777411 |
EV-RB1401 |
|
December 2014 |
January 2016 |
January 2016 |
May 19, 2016 |
November 30, 2016 |
|
- China Medical University Hospital
Taichung, Taiwan - National Taiwan University Hospital
Taipei, Taiwan - Taipei Veterans General Hospital
Taipei, Taiwan - Linkou Chang Gung Memorial Hospital
Tao Yuan, Taiwan
|
|
| 32 |
NCT03268083 |
Active, not recruiting |
A Study to Evaluate the Immunogenicity and Safety of EV71 Vaccine in Pediatric Subjects Aged 3 to 6 Years and 2 to 35 Months Old |
|
- Biological: EV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AI(OH)3] per dose)
- Biological: EV71 vaccine ([1 μg total protein + adjuvant 150 μg AI(OH)3] per dose)
- Biological: EV71 vaccine ([1 μg total protein ] per dose)
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Serum neutralizing antibody titers (NT) induced by the EV71 vaccine
- Seroconversion rate (SCR) based on neutralizing antibody titers
- Solicited adverse events
- (and 3 more...)
|
140 |
All |
2 Months to 6 Years (Child) |
NCT03268083 |
EV-BR1501 |
|
July 2016 |
August 2017 |
December 2017 |
August 31, 2017 |
August 31, 2017 |
|
- Sherry Chen
Taipei, Da-an Dist, Taiwan
|
|
| 33 |
NCT01569581 |
Completed |
A Protected Study of Inactivated EV71 Vaccine (Human Diploid Cell, KMB-17) in Chinese Infants and Children |
- The Efficacy of Inactivated EV71 Vaccine (KMB17) Against HFMD in Chinese Children and Infants
|
- Biological: 100U/0.5ml in 6-11 months old infants
- Biological: 100U/0.5ml in 12-23 months old infants
- Biological: 100U/0.5ml in 24-35 months old children
- Biological: 100U/0.5ml in 36-71 months old children
|
Interventional
|
Phase 3 |
- Chinese Academy of Medical Sciences
- Guangxi Center for Disease Control and Prevention
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Prevention
|
- Evaluate the safety of Inactivated EV 71 Vaccine (Human Diploid Cell, KMB-17) in Chinese Infants and children (from 6 to 71 months old)
- Evaluate the efficacy of Inactivated EV 71 Vaccine (Human Diploid Cell, KMB-17) in Chinese Infants and children (from 6 to 71 months old)
- Evaluate the seroconversion rate of anti-EV71 antibodies in serum of children and infant, after first vaccination
- Evaluate the seroconversion rate of anti-EV71 antibodies in serum of children and infant, after second vaccination
|
12000 |
All |
6 Months to 71 Months (Child) |
NCT01569581 |
EV71-KMB17-III-IMB-CAMS |
|
March 2012 |
March 2013 |
March 2013 |
April 3, 2012 |
March 12, 2013 |
|
- Guangxi Provincial Center for Diseases Control and Prevention
Nanning, Guangxi, China
|
|
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