Safety Study of Enterovirus 71 Vaccine in Children Aged 6-35 Months Old

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

20000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Brief Summary

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This phase IV clinical study evaluates the safety of enterovirus 71 vaccine in children aged 6-35 months old by the method of both passive and active surveillance.

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Detailed Description

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Conditions

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Enterovirus 71 Vaccine

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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two doses enterovirus 71 vaccine

Two doses of enterovirus 71 vaccine will be given in aged 6-35 months old, 28 days interval.

Group Type EXPERIMENTAL

two doses enterovirus 71 vaccine

Intervention Type BIOLOGICAL

Two doses of enterovirus 71 vaccine will be given in children aged 6-35 months old, 28 days interval.

Interventions

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two doses enterovirus 71 vaccine

Two doses of enterovirus 71 vaccine will be given in children aged 6-35 months old, 28 days interval.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Infant and toddlers aged 6 and 35 months, meeting the criteria of receiving vaccine based on the judgement of caregivers at vaccination clinic. And The legal guardian are willing to vaccination at his own expense.

Exclusion Criteria

* History of allergy to any vaccine ingredient or gentamycin;
* Fever, or acute disease, or acute stage of chronic disease;
* Having serious chronic diseases, or allergic constitution;
* Refusal of follow-up for safety concern.

Minimum Eligible Age

6 Months

Maximum Eligible Age

35 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes