37 completed, 14 unknown, 4 not yet recruiting, 3 recruiting. 15 Phase 4, 12 Phase 1, 9 Not applicable, 9 Phase 2, 9 Phase 3.
Follow Hand, Foot and Mouth Disease: new trials by email Literature Review of Hand, Foot and Mouth Disease trials Research Report on Hand, Foot and Mouth Disease
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| CHIPCAT and HFMD-PREP for HFMD Prevention in Childcare Centres in Kota Kinabalu HFMD-PREP (HFMD Prevention and Response Enhancement Programme) - Hand, Foot and Mouth Disease, Infection Control | Not applicable | Not yet recruiting | Helmy Sajali, MD, MPH | 780 | 2026-10-01 | 2026-10-13 |
| Bridging Clinical Trial of EV71 Vaccine in Vietnamese Children EV71 vaccine - Hand, Foot, and Mouth Disease (HFMD), Enterovirus 71 Infection | Not applicable | Not yet recruiting | Sinovac Biotech Co., Ltd | 320 | 2026-09-19 | 2026-09-01 |
| Protective Efficacy , Immunogenicity and Safety of the Tetravalent Inactivated Enterovirus Vaccine (Vero Cell). Tetravalent Inactivated Enterovirus Vaccine (Vero Cell), Placebo - Hand, Foot, and Mouth Disease(HFMD), Herpangina | Phase 3 | Not yet recruiting | Sinovac Biotech Co., Ltd | 6000 | 2026-05-01 | 2026-05-28 |
| Phase I Clinical Trial of Enterovirus Type71 - Coxsackievirus Type A16 Bivalent Vaccine Low Dose Enterovirus Type71 - Coxsackievirus Type A16 bivalent vaccine, inactivated (human diploid cell), Medium Dose Enterovirus Type71 - Coxsackievirus Type A16 bivalent vaccine, inactivated (human diploid cell), High Dose Enterovirus Type71 - Coxsackievirus Type A16 bivalent vaccine, inactivated (human diploid cell) - Hand, Foot and Mouth Disease (HFMD), HFMD | Phase 1 | Not yet recruiting | Institute of Medical Biology, Chinese Academy of Medical Sciences | 144 | 2025-12-30 | 2026-01-08 |
| Study on the Persistence of Immunity Following EV71 Vaccination Hand, Foot, and Mouth Disease, Hand, Foot, and Mouth Disease (HFMD) | Enrolling by invitation | Institute of Medical Biology, Chinese Academy of Medical Sciences | 270 | 2025-08-10 | 2025-08-27 | |
| Tolerability, Safety, and Immunogenicity of Tetravalent Inactivated Enterovirus Vaccine (Vero Cell). 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) ) - Hand, Foot, and Mouth Disease (HFMD), Herpangina | Phase 1 / Phase 2 | Completed | Sinovac Biotech Co., Ltd | 552 | 2025-01-15 | 2026-03-04 |
| Efficacy, Safety, and Immunogenicity of the Bivalent Inactivated Enterovirus Vaccine (Vero Cell) bivalent enterovirus vaccine (Vero cell), inactivated, Enterovirus Type 71 Vaccine (Vero Cell), Inactivated - Hand, Foot, and Mouth Disease（HFMD) | Phase 3 | Recruiting | Sinovac Biotech Co., Ltd | 8000 | 2024-12-13 | 2025-01-01 |
| Artificial Intelligence-driven Virtual Standardized Pediatric Patients Trial Virtual standardized patients (VSPs), Case teaching manuals, Case teaching videos - Pneumococcal Pneumonia, Rotavirus Enteritis With Hypovolemic Shock | Not applicable | Recruiting | Southern Medical University, China | 459 | 2024-12-01 | 2024-12-19 |
| Active Case Finding of Clinical Hand Foot Mouth Disease in Children Aged 6 Months Old to 18 Years Old in Indonesia PCR - Hand, Foot and Mouth Disease | Unknown | Sinovac Biotech Co., Ltd | 100 | 2024-02-01 | 2024-02-09 | |
| Lot-to-lot Consistency Study of Three Commercial Batches of Enterovirus 71 Vaccine EV71 Vaccine - Hand, Foot and Mouth Disease | Phase 4 | Unknown | Institute of Medical Biology, Chinese Academy of Medical Sciences | 1500 | 2023-11-25 | 2024-01-03 |
| Inactivated Bivalent Enterovirus Vaccine (Vero Cell) Phase I/II Clinical Trial low dose Bivalent Enterovirus Vaccine (Vero Cell), Inactivated, medium dose Bivalent Enterovirus Vaccine (Vero Cell), Inactivated, high dose Bivalent Enterovirus Vaccine (Vero Cell), Inactivated - Hand, Foot and Mouth Disease, Herpangina | Phase 1 / Phase 2 | Completed | Sinovac Biotech Co., Ltd | 744 | 2023-09-20 | 2026-06-26 |
| Surveillance of HFMD in Pediatric Outpatients Throat/buccal swab sample - Hand, Foot and Mouth Disease, Herpangina | Recruiting | University Hospital, Clermont-Ferrand | 3000 | 2023-06-20 | 2024-02-16 | |
| A Serosurvey Study of Hand, Foot, and Mouth Disease in Indonesia Hand, Foot and Mouth Disease | Completed | Sinovac Biotech Co., Ltd | 600 | 2022-11-28 | 2023-10-31 | |
| An Immunity Persistence Study of Enterovirus 71 Inactivated Vaccine (Vero Cell) Experimental Vaccine, Control Vaccine - Hand, Foot and Mouth Disease | Phase 4 | Unknown | Sinovac Biotech Co., Ltd | 474 | 2022-07-30 | 2022-06-10 |
| Safety Observation of Enterovirus 71 Inactivated Vaccine (Vero Cell) Combined Immunization in Shanghai EV71 Inactivated Vaccine - Hand, Foot and Mouth Disease | Unknown | Sinovac Biotech Co., Ltd | 12500 | 2022-01-04 | 2022-07-11 | |
| Safety and Immunogenicity of High-dose IN-B001 in Healthy Subjects IN-B001 EV71 A dose, IN-B001 CVA16 B dose, IN-B001 Bivalent C dose - Hand, Foot and Mouth Disease | Phase 1 | Unknown | HK inno.N Corporation | 30 | 2020-12-01 | 2020-11-20 |
| Safety & Immunogenicity of Enterovirus Type 71 Vaccine in Healthy Adults and Children 6-71months Inactivated Enterovirus Type 71 (EV71) Vaccine (Vero Cell) - Hand Foot & Mouth Disease | Phase 1 / Phase 2 | Completed | International Centre for Diarrhoeal Disease Research, Bangladesh | 430 | 2019-12-24 | 2021-02-02 |
| Safety and Immunogenicity of CJ-40010 in Healthy Subjects CJ-40010 EV71 vaccine A dose, CJ-40010 EV71 vaccine B dose, CJ-40010 CVA16 vaccine C dose - Hand, Foot and Mouth Disease | Phase 1 | Unknown | HK inno.N Corporation | 60 | 2019-12-02 | 2019-12-03 |
| The Immunogenicity and Safety of the Vaccination of Inactivated Enterovirus 71 Vaccine and Seasonal Influenza Vaccine EV71 +SIV, EV71, SIV - Seasonal Influenza, Hand, Foot and Mouth Disease | Phase 4 | Completed | Zhejiang Provincial Center for Disease Control and Prevention | 1134 | 2019-09-16 | 2022-07-13 |
| Safety and Immunogenicity of Concomitant Administration of EV71 Vaccine With Expanded Programme on Immunization Vaccines Concomitant administration of EV71vaccine with EPI vaccines, Single injection of EPI vaccine, EV71 Vaccine only - Hand, Foot and Mouth Disease | Phase 4 | Completed | Sinovac Biotech Co., Ltd | 372 | 2019-07-26 | 2021-07-29 |
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Enterovirus Infections (9) · Herpangina (7) · Mouth Diseases (3) · Foot-and-Mouth Disease (2) · Appendicitis (1) · Coxsackievirus Infections (1) · Encephalitis (1) · Fever (1) · Infections (1) · Pneumonia, Pneumococcal (1) · Respiratory Insufficiency (1)
Picornaviridae Infections (59) · RNA Virus Infections (59) · Virus Diseases (59) · Coxsackievirus Infections (58) · Infections (58) · Enterovirus Infections (50) · Echovirus Infections (7) · Stomatognathic Diseases (3) · Animal Diseases (2) · Bacterial Infections (1) · Bacterial Infections and Mycoses (1) · Body Temperature Changes (1) · Brain Diseases (1) · Cecal Diseases (1) · Central Nervous System Diseases (1)
Adjuvants, Pharmaceutic (2) · reduning (2) · Acetaminophen (1) · Control Groups (1) · Hepatitis B Vaccines (1) · Ibuprofen (1) · Immunoglobulins (1) · Magnesium Sulfate (1) · Mannitol (1) · Methylprednisolone (1) · Sodium Chloride (1) · Sucralfate (1) · Suramin (1) · Therapeutics (1) · Vaccines (1)
Sinovac Biotech Co., Ltd (20) · Institute of Medical Biology, Chinese Academy of Medical Sciences (7) · Jiangsu Province Centers for Disease Control and Prevention (7) · Enimmune Corporation (3) · Chinese Academy of Medical Sciences (2) · HK inno.N Corporation (2) · Oxford University Clinical Research Unit, Vietnam (2) · The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine (2) · Beijing Chaoyang District Centre for Disease Control and Prevention (1) · Beijing YouAn Hospital (1) · China Academy of Chinese Medical Sciences (1) · Eskisehir Osmangazi University (1) · First Affiliated Hospital of Zhejiang University (1) · Helmy Sajali, MD, MPH (1) · International Centre for Diarrhoeal Disease Research, Bangladesh (1)
China (41) · Vietnam (4) · Taiwan (3) · South Korea (2) · Bangladesh (1) · France (1) · Indonesia (1) · Malaysia (1) · Singapore (1) · Turkey (Türkiye) (1) · United States (1)
Zhaojun Mo, Master (3) · Fengcai Zhu, Master (2) · Guoliang Zhang (2) · Xuhua Guan, M.S. (2) · AIqiang Xu (1) · Boyan Liu, chief physician (1) · Bridget Wills, MD (1) · Chin-Fen Yang (1) · Feng-Cai Zhu, BS (1) · Feng-Cai Zhu, Master (1) · Feng-cai Zhu, Master (1) · Guoliang Zhang, chief (1) · Hua Wang, BS (1)
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