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

Beijing Chaoyang District Centre for Disease Control and Prevention20,000 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

20,000

Conditions

Enterovirus 71 Vaccine

Interventions

two doses enterovirus 71 vaccineBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 35 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

The rate of adverse reactions of enterovirus 71 Vaccine

Adverse reactions associated with vaccine will be observed in subjects after each vaccination. Solicited local adverse events include Pain, Redness, Swelling, Induration, Rash, Pruritus at injection site. solicited general adverse events include Fever, Nausea, Vomiting, Diarrhea, Decreased appetite, Be agitated (irritability, abnormal crying), fatigue, allergy

Time frame: 28 days

Data from ClinicalTrials.gov

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