Effectiveness and Safety of Inactivated EV71 Vaccine (Human Diploid Cell) in 6-71 Months Children: an Open-label Controlled Phase Ⅳ Clinical Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40,724
- 试验地点
- 1
- 主要终点
- The effectiveness of inactivated EV71 vaccine in preventing hand-foot-and-mouth disease (HFMD) caused by Enterovirus 71 (EV71) in large scale population of Chinese children (from 6 to 71 months old) in Hubei Province, China.
研究概览
简要总结
Enterovirus 71 (EV71), a major pathogen causing hand-foot-and-mouth disease (HFMD) worldwide, is a member of the Human Enterovirus species A, family Picornaviridae. Its infection occasionally leads to severe diseases and death, with central nervous system (CNS) damage.
An inactivated EV71 vaccine (Human Diploid cell, KMB-17 Cell) has been finished phase I, II and III clinical trials and licensed by CFDA in China at Dec. 3, 2015. Based on the results of clinical trials, the protective efficacy of inactivated EV71 vaccine is 97% against HFMD caused by EV71. The target population is determined to be susceptible children aged 6 to 71 months; this target population is well known as a major global population with strict requirements for safety and efficacy of vaccines in implementing the World Health Organization (WHO) Expanded Program on Immunization (EPI) . Thus, it is necessary and significant to conduct a postmarketing phase IV trial in large populations for long-term observation to evaluate the distinctive effectiveness and to identify potential safety issues .
This study is an open-label and controlled postmarketing phase IV trial on children aged 6-71 months who resided in 3 districts of Xiangyang City, Hubei Province, China.
详细描述
Primary Objective: To evaluate the effectiveness of EV71 vaccine after mass vaccination in a large population (Chinese healthy children aged 6-71 months) for preventing against EV71-associated hand, foot and mouth disease.
Secondary Objective: To evaluate the safety of EV71 vaccine after mass vaccination in a large population (Chinese healthy children aged 6-71 months).
Participants: The children aged 6-71 months in the study area registered in August 2016 in the Childhood Immunization Information Management System (CIIMS) in Hubei Province are designated as study population. Of these children, 39189 will be recruited in the vaccine group for receiving 2 doses of EV71 inactivated vaccine at an interval of 1 month. The remaining children will be used as the control group.
Sampling size: The total sample size is primarily calculated based on the previous HFMD monitoring data of the study sites from 2010 to 2015 by stratifying the data into 6 age groups as follows: 6-11 months, 12-23 months, 24-35 months, 36-47 months, 48-59 months and 60-71 months, respectively. Prior to the identification of minimum annual HFMD incidences caused by EV71 infection are 0.08%-6.05% (data not shown). Assuming a vaccine effectiveness of 90% , power of 0.80 with a 0.05 significance level (two-tailed), and drop-out rate of 20% , the sample size would be 39189 in the vaccine group.
Standard Operating Procedures:
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 71 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects (6-71 months old children)
- •The subjects' legal guardian voluntarily participate in the study and signed Informed Consent Form
- •The subjects' legal guardian with the ability and objective to comply with the requirements of the protocol
排除标准
- •Allergy to a vaccine , any ingredient of vaccine or substance used in the preparation process including excipients, formaldehyde, and kanamycin sulfate.
- •Fever, acute illness
- •Severe chronic disease, allergic diathesis
结局指标
主要结局
The effectiveness of inactivated EV71 vaccine in preventing hand-foot-and-mouth disease (HFMD) caused by Enterovirus 71 (EV71) in large scale population of Chinese children (from 6 to 71 months old) in Hubei Province, China.
时间窗: Up to 14 months from twenty-eight days p.i.of the 2nd vaccination dose
The effectiveness of inactivated EV71 vaccine and 95% confidence intervals were calculated on the basis of the observed difference of incidence between the children (from 6 to 71 months old) who were vaccinated and those who were not vaccinated.
次要结局
- Incidence of treatment adverse events(Within 30 days postinoculation each dose)