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

Beijing Chaoyang District Centre for Disease Control and Prevention0 个研究点目标入组 20,000 人开始时间: 2016年7月1日最近更新: 2016年6月20日

适应症

试验速览

阶段: 4 期
发起方
入组人数: 20,000
主要终点: The rate of adverse reactions of enterovirus 71 Vaccine

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Prevention
盲法: None

入排标准

年龄范围: 6 Months 至 35 Months（Child）
性别: All
接受健康志愿者: 是

入选标准

•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.

排除标准

•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.

结局指标

主要结局

The rate of adverse reactions of enterovirus 71 Vaccine

时间窗: 28 days

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

次要结局

未报告次要终点

研究者

发起方

Beijing Chaoyang District Centre for Disease Control and Prevention

申办方类型

Other

责任方

Sponsor

相似试验

已完成

4 期

Phase IV Clinical Trial, Immunogenicity and Safety of EV71 VaccineHand, Foot and Mouth Disease

NCT03278132Sinovac Biotech Co., Ltd120

Unknown

不适用

Safety Observation of Enterovirus 71 Inactivated Vaccine (Vero Cell) Combined Immunization in ShanghaiHand, Foot and Mouth Disease

NCT05166044Sinovac Biotech Co., Ltd12,500

已完成

3 期

A Study to Evaluate the Efficacy, Immunogenicity and Safety of an EV71 Vaccine in Healthy Infants and ChildrenEnterovirus Infections

NCT05099029Enimmune Corporation3,982

已完成

3 期

An Efficacy Trial in Inactivated Enterovirus Type 71 (EV71) VaccineHand, Foot and Mouth Disease

NCT01507857Sinovac Biotech Co., Ltd10,077

已完成

4 期

The Phase IVb of Inactivated Enterovirus 71 Vaccine (Human Diploid Cell, KMB-17) in Chinese ChildrenHand, Foot and Mouth Disease (HFMD)

NCT03001986Institute of Medical Biology, Chinese Academy of Medical Sciences40,724