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

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

343 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-20

Study Completion Date

2017-05-21

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hand, Foot and Mouth Disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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EV71 vaccine group

The group which received two doses EV71 vaccine (400U/0.5ml) on day 0,28 in phase III clinical trial.

No interventions assigned to this group

Placebo group

The group which received two doses placebo (0U/0.5ml) on day 0,28 in phase III clinical trial.

No interventions assigned to this group

Eligibility Criteria

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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