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COMPLETEDNCT03281174

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

The purpose of this study is to evaluate the 5-year Immune Persistence of Inactivated Enterovirus Type 71 (EV71) Vaccine manufactured by Sinovac (Beijing) Biotech Co., Ltd.

Lead sponsor: Sinovac Biotech Co., Ltd•1 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Sinovac Biotech Co., Ltd

The phase III, efficacy trial of inactivated vaccine (vero cell) against EV71 has completed on March 2013 in China,and a follow up study for phase III clinical trial has completed on March 2014. On the basis of phase III, this study is the Phase IV, open-labelled research, in order to evaluate the 5-year immune persistence of EV71 vaccine.

Age

0 - 2 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•In the prior phase III clinical trial, 10077 subjects in three counties (Ganyu, Sheyang and Taixing ) were enrolled ( Experimental group: 5044; Control group: 5043 ), with 1293 of them in immunogenicity subgroup (Experimental group: 648; Control group: 645). In Sheyang county, 3351 subjects were enrolled (Experimental group: 1676 ; Control group :1675) , with 435 of them in immunogenicity subgroup (Experimental group: 418 ; Control group :418).
•The subjects in Sheyang immunogenicity subgroup with the following conditions were included in this study:
•Guardian(s) of the volunteer should be capable of understanding the written consent form, and such form should be signed before the infant being included into this study
•Received at least one injection of EV71 vaccine or the placebo in the phase III clinical trial
•Finished the blood sampling 64 months after the vaccination

Exclusion Criteria

•Received extra EV71 vaccination after the phase III clinical trial
•Refused to join the study

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: September 13, 2017Terms

Trial snapshot

StatusCOMPLETED

Phase—

Enrollment343

Start dateMay 2017

Last updatedSep 13, 2017

Condition

Hand, Foot and Mouth Disease

Locations shown

Sheyang Center for Disease Control and Prevention

Yancheng, Jiangsu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 13, 2017Data synced to Clareo: May 3, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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