A Follow-up Study for a Phase III, Efficacy Trial in Inactivated Enterovirus Type 71 (EV71) Vaccine
NCT ID: NCT02001233
Last Updated: 2022-05-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
10077 participants
OBSERVATIONAL
2013-03-31
2014-10-31
Brief Summary
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Detailed Description
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This study is the phase III, open-labelled, follow-up research, in order to evaluate the two-year efficacy, safety and immune persistence.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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EV71 Vaccine
Inactivated vaccine (vero cell) against EV71 of 400U /0.5ml in 5000 infants aged 6-35 months old on day0,28
EV71 vaccine
inactivated vaccine (vero cell) against EV71 of 400U /0.5ml, two doses, 28 days interval
Placebo
placebo in 5000 infants aged 6-35 months old on day0,28
No interventions assigned to this group
Interventions
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EV71 vaccine
inactivated vaccine (vero cell) against EV71 of 400U /0.5ml, two doses, 28 days interval
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
6 Months
35 Months
ALL
Yes
Sponsors
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Sinovac Biotech Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Feng-Cai Zhu, BS
Role: PRINCIPAL_INVESTIGATOR
Jiangsu Center for Diseases Control and Prevention
Locations
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Ganyu
Lianyungang, Jiangsu, China
Taixing
Taizhou, Jiangsu, China
Sheyang
Yancheng, Jiangsu, China
Countries
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Other Identifiers
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PRO-EV71-3003-0
Identifier Type: -
Identifier Source: org_study_id
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