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Hand, Foot and Mouth Disease

10
Pipeline Programs
2
Companies
16
Clinical Trials
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
1
0
0
3
6
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Vaccine
11100%
+ 5 programs with unclassified modality

Competitive Landscape

2 companies ranked by most advanced pipeline stage

Sinovac Biotech
Sinovac BiotechChina - Beijing
15 programs
1
3
6
5000 volunteersPhase 41 trial
Concomitant administration of EV71 vaccine with EPI vaccinesPhase 4Vaccine1 trial
Concomitant administration of EV71vaccine with EPI vaccinesPhase 41 trial
EV71 inactived vaccine（Vero cells）Phase 4Vaccine1 trial
EV71 vaccinePhase 4Vaccine1 trial
+10 more programs
Active Trials
NCT05637229Completed600Est. Dec 2022
NCT05166044Unknown12,500Est. Aug 2022
NCT02001233Completed10,077Est. Oct 2014
+12 more trials
Takeda
TakedaTOKYO, Japan
1 program
INV21 Low DosePHASE_11 trial
Active Trials
NCT01376479Completed36Est. Apr 2012

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
Sinovac BiotechExperimental Vaccine
Sinovac BiotechConcomitant administration of EV71vaccine with EPI vaccines
Sinovac Biotech5000 volunteers
Sinovac BiotechEV71 inactived vaccine（Vero cells）
Sinovac BiotechEV71 vaccine
Sinovac BiotechConcomitant administration of EV71 vaccine with EPI vaccines
Sinovac Biotech36-71 months old children-experimental EV71 vaccine.
Sinovac Biotechthree consecutive lots of EV71 vaccine
Sinovac Biotech400U /0.5ml EV71 vaccine
Sinovac Biotechlow dose Bivalent Enterovirus Vaccine
TakedaINV21 Low Dose
Sinovac BiotechPCR
Sinovac BiotechA Serosurvey Study of Hand, Foot, and Mouth Disease in Indonesia
Sinovac BiotechEV71 Inactivated Vaccine
Sinovac BiotechFive-year Immune Persistence Study of Inactivated Enterovirus Type 71 (EV71) Vaccine

Showing 15 of 16 trials with date data

Clinical Trials (16)

Total enrollment: 54,323 patients across 16 trials

NCT05397587Sinovac BiotechExperimental Vaccine

An Immunity Persistence Study of Enterovirus 71 Inactivated Vaccine (Vero Cell)

Start: Jul 2022Est. completion: Oct 2025474 patients
Phase 4Unknown
NCT04111432Sinovac BiotechConcomitant administration of EV71vaccine with EPI vaccines

Safety and Immunogenicity of Concomitant Administration of EV71 Vaccine With Expanded Programme on Immunization Vaccines

Start: Jul 2019Est. completion: Mar 2020372 patients
Phase 4Completed
NCT03903926Sinovac Biotech5000 volunteers

Efficacy Trial of a Commercial EV71 Vaccine

Start: Mar 2019Est. completion: Oct 202015,500 patients
Phase 4Completed
NCT03873740Sinovac BiotechEV71 inactived vaccine（Vero cells）

Immunogenicity and Safety of Two Different Commercial EV71 Vaccines

Start: Nov 2018Est. completion: Jan 2019300 patients
Phase 4Completed
NCT03278132Sinovac BiotechEV71 vaccine

Phase IV Clinical Trial, Immunogenicity and Safety of EV71 Vaccine

Start: Jul 2017Est. completion: Sep 2017120 patients
Phase 4Completed
NCT03274102Sinovac BiotechConcomitant administration of EV71 vaccine with EPI vaccines

Safety and Immunogenicity of Concomitant Administration of EV71 Vaccine With EPI Vaccines

Start: Apr 2017Est. completion: Nov 2017780 patients
Phase 4Completed
NCT03909074Sinovac Biotech36-71 months old children-experimental EV71 vaccine.

Clinical Trial of Enterovirus 71（EV71） Inactivated Vaccine in Children Aged 36-71 Months

Start: Mar 2019Est. completion: Nov 2019900 patients
Phase 3Completed
NCT01636245Sinovac Biotechthree consecutive lots of EV71 vaccine

Immunogenicity and Safety of Three Consecutive Lots of a New Inactivated Enterovirus Type 71 (EV71) Vaccine

Start: Jul 2012Est. completion: Feb 20131,400 patients
Phase 3Completed
NCT01507857Sinovac Biotech400U /0.5ml EV71 vaccine

An Efficacy Trial in Inactivated Enterovirus Type 71 (EV71) Vaccine

Start: Jan 2012Est. completion: Mar 201310,077 patients
Phase 3Completed
NCT06063057Sinovac Biotechlow dose Bivalent Enterovirus Vaccine

Inactivated Bivalent Enterovirus Vaccine (Vero Cell) Phase I/II Clinical Trial

Start: Sep 2023Est. completion: Mar 2026744 patients
Phase 1/2Active Not Recruiting
NCT01376479TakedaINV21 Low Dose

Safety and Immunogenicity Study of an Inactivated Vaccine Against Hand, Foot and Mouth Disease Caused by Enterovirus 71

Start: Aug 2011Est. completion: Apr 201236 patients
Phase 1Completed
NCT06251219Sinovac BiotechPCR

Active Case Finding of Clinical Hand Foot Mouth Disease in Children Aged 6 Months Old to 18 Years Old in Indonesia

Start: Feb 2024Est. completion: Jun 2025100 patients
N/AUnknown
NCT05637229Sinovac BiotechA Serosurvey Study of Hand, Foot, and Mouth Disease in Indonesia

A Serosurvey Study of Hand, Foot, and Mouth Disease in Indonesia

Start: Nov 2022Est. completion: Dec 2022600 patients
N/ACompleted
NCT05166044Sinovac BiotechEV71 Inactivated Vaccine

Safety Observation of Enterovirus 71 Inactivated Vaccine (Vero Cell) Combined Immunization in Shanghai

Start: Jan 2022Est. completion: Aug 202212,500 patients
N/AUnknown
NCT03281174Sinovac BiotechFive-year Immune Persistence Study of Inactivated Enterovirus Type 71 (EV71) Vaccine

Five-year Immune Persistence Study of Inactivated Enterovirus Type 71 (EV71) Vaccine

Start: May 2017Est. completion: May 2017343 patients
N/ACompleted
NCT02001233Sinovac BiotechEV71 vaccine

A Follow-up Study for a Phase III, Efficacy Trial in Inactivated Enterovirus Type 71 (EV71) Vaccine

Start: Mar 2013Est. completion: Oct 201410,077 patients
N/ACompleted

Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

3 late-stage (Phase 3) programs, potential near-term approvals
Vaccine is the dominant modality (100% of programs)
2 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.