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400U / EV71 vaccine

Phase 3

Hand, Foot and Mouth Disease | Monoclonal antibody | Other |Sinovac Biotech, Ltd|Last Updated: Nov 28, 2013

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment10,077
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01507857An Efficacy Trial in Inactivated Enterovirus Type 71 (EV71) VaccinePHASE3 COMPLETED 10,077 — — Jan 1, 2012Mar 1, 2013Nov 28, 20133 China
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Study Endpoints
Primary Endpoints
The incidence rate of Hand, Foot and Mouth disease caused by EV71 within one year observation period after the second vaccination
From 28 days after the second vaccination to one year

to evaluate the efficacy of EV71 vacccine against HFMD caused by EV71

Secondary Endpoints
The GMT of anti-EV71 antibodies in serum after second vaccination
28 days after first vaccination
The GMT of anti-EV71 antibodies in serum 7 and 13 months after second vaccination
7 and 13 months after second vaccination
Frequency of systemic and local adverse reactions after the first vaccination
28 days after the first vaccination
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
400U /0.5ml in infantsEXPERIMENTALinactivated vaccine(vero cell) against EV71 of 400U /0.5ml in 5000 infants aged 6-35 months old on day0,28
0/0.5ml placebo in infantsPLACEBO_COMPARATOR0/0.5ml placebo in 5000 infants aged 6-35 months old on day0,28
Interventions
NameTypeDescription
400U /0.5ml EV71 vaccineBIOLOGICALinactivated vaccine (vero cell) against EV71 of 400U /0.5ml, two doses, 28 days interval
0/0.5ml placeboBIOLOGICAL0/0.5ml placebo, two doses, 28 days interval
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Eligibility Criteria
Age Range6 Months — 35 Months
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * Healthy males and females, aged from 6 months to 11 years old Health is determined by medical history, physical examination, laboratory examination and clinical judgment of the investigator * Provided legal identification for the sake of recruitment * Subjects and/or parent(s)...

Countries:China
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