近日，有媒体报道称，“江苏泰兴分界镇有婴儿被注射未上市手足口病疫苗，卫生中心承认是临床试验，但是家长不知情。”江苏省疾控中心及泰兴市疾控中心相关负责人1月25日在接受本报记者采访时回应，所有接受该项目疫苗的婴儿都由监护人签署知情同意书，不存在婴儿监护人不知情、强迫进行接种的情况。疾控中心表示，在家属授权同意、揭盲程序开始以后，愿意公开一切资料。

recently,Media reports said,"Jiangsu TaiXing FenJieZhen have babies are injection not listed hand, foot and mouth disease vaccine,Health center admitted that clinical trials,But parents don't know."Jiangsu province CDC and taixing city CDC on January 25, the relevant person in charge in an interview with our reporter response,All accept the project vaccine baby are made by a signed informed consent,Does not exist baby guardian not informed/Forced the inoculation.CDC said,In the family agreed to authorized/The blind program started later,All information to the public.

　　据介绍，此次在泰州实施的项目为肠道病毒71型灭活疫苗三期临床试验，该项目于2010年12月23日经国家食品药品监督管理局批准，江苏省疾病预防控制中心为负责单位。该疫苗用于预防EV71感染引起的一系列疾病，如手足口病、中枢神经系统感染疾病等，尤其是重症手足口病。

According to introducing,The implementation of the project in taizhou for intestinal virus type 71 inactivated vaccine three phase of clinical test,This project in December 2010 and the state food and drug administration approved,Jiangsu province disease prevention and control center for responsible department.The vaccine to prevent infection EV71 causes a series of disease,Such as hand, foot and mouth disease/The central nervous system infection disease,Especially severe hand, foot and mouth disease.

　　泰兴市疾控中心主任姚根红介绍，2011年年底，由疾控中心、镇卫生院等工作人员在当地针对符合条件的婴儿进行上门宣传，邀请愿意参加临床试验的家长在2012年1月10日到镇卫生院登记、签署知情同意书、体检并现场打第一针疫苗。以泰兴市分界镇为例，共有适龄儿童482人，口头招募204人，现场招聘199人，知情同意197人，知情不同意2人。

Taixing city, director of the center for disease control and YaoGenGong is introduced,By the end of 2011,The centers for disease control and/Township health centers in local work personnel to meet the conditions of the baby on the door propaganda,Invite parents to participate in clinical trials in January 10, 2012 township health centers to register/Informed consent signed/The medical and play the first needle vaccine.To FenJieZhen taixing city as an example,There are 482 school-age children,Oral recruited 204 people,Recruitment 199 people,Informed consent 197 people,Informed don't agree with 2 people.

　　“所有接种的婴儿，都由带着来的监护人签署了知情同意书。为了方便识别接种疫苗的婴儿身份，我们对每一个婴儿都进行了现场拍照。”姚根红称，“整个流程的每一个阶段，都是由各级有关部门在现场进行监督的，没有在幼儿园、学校等场所进行宣传、接种；不可能存在不知情而强迫接种的情况。”

"All inoculation baby,By with the guardian signed the consent of knowledge.In order to facilitate the identification of vaccination baby identity,We to each baby are the photos."YaoGenGong says,"The whole process of every stage,Are made by the relevant departments at all levels in the field of supervision,Not in kindergarten/Schools and other places for publicity/inoculation;Impossible not informed and forced the inoculation."

　　1月25日，江苏省疾控中心工作人员向记者出示了媒体报道中涉及的两位当事人相关资料，知情同意书包括疾病概述、研究疫苗、研究概况、可能的风险等内容。记者看到报道中所提及的两名婴儿杨某与祖母、赵某与祖父在接种现场所照照片复印件及有杨某祖母、赵某祖父签名的知情同意书复印件；此外，随访记录表上，也详细记录了这两名婴儿接受疫苗后的随访及病情记录。

On January 25th,Jiangsu province CDC staff told reporters presented the media reports of the parties involved in two related material,Informed consent paper including disease/A vaccine/Research situation/Possible risk, etc.The reporter sees in the report mentioned two baby Yang and grandmother/ZhaoMou and grandfather in vaccination site copy according to photos and Yang grandmother/ZhaoMou grandfather signed consent to familiar with the copy;In addition,Follow-up data sheet on,Also a detailed record of the two baby vaccinated after the follow-up and illness record.

　　根据记录，这两个孩子都曾在接种疫苗半年后出现三次疑似手足口病的情况，经查，各有一次确实感染了手足口病，但感染原因均排除了EV71，即与注射的疫苗无关。

According to records,The two children have been vaccinated after half a year in three suspected of hand, foot and mouth disease,The basis of,Each has a really infected with hand, foot and mouth disease,But the infection causes are ruled out EV71,That has nothing to do with the injection of the vaccine.

　　“注射疫苗后仍然感染，可能有几个原因。首先，手足口病类型比较复杂，此项疫苗只能预防EV71，但柯萨奇病毒A16型等也会引起手足口病；其次，临床试验是双盲的，也就是有对照组是服用了安慰剂，所以未能显示出效果，但是这两名婴儿是否是对照组，目前还不到揭盲的时候。”江苏省疾控中心副主任朱凤才告诉记者。

"Flu vaccines are still infection,There could be several reasons.First of all,Hand, foot and mouth disease type is more complex,The vaccine can prevent EV71,But coxsackie virus A16 type can also cause such as hand, foot and mouth disease;secondly,Clinical trials are double blind,Is a control group is taking a placebo,So failed to show results,But the two baby is control group,There is less than when the blind."Jiangsu province, deputy director of the centers for disease control and ZhuFengCai told reporters.

　　在采访中，江苏省及泰兴市疾控中心有关负责人均表示，根据相关法律法规规定，接种疫苗的个人信息不能公开，在家属授权同意、揭盲程序开始以后，愿意公开一切资料。

In the interview,Taixing city in jiangsu province and the center for disease control related to per capita said,According to relevant laws and regulations,Vaccination personal information can't open,In the family agreed to authorized/The blind program started later,All information to the public.

　　朱凤才介绍，该次临床试验，有国家食品药品监督管理局《药物临床试验批件》(批件号：2010L05007)，经过了江苏省疾控中心伦理委员会审核通过。“此前已经完成的一期、二期临床研究表明，该疫苗在婴幼儿中具有良好的安全性，且能产生较高的抗体水平。”

ZhuFengCai introduced,This time the clinical test,Have the state food and drug administration[The approval of drug clinical trials](Approval number:2010 l05007),After the jiangsu province CDC ethics committee approved."Had already completed a period/Phase ii clinical study,The vaccine in young infants with good safety,And can produce higher levels of antibodies."

　　在接受采访时，姚根红坦言，泰兴分界镇等地，由于外出务工人员较多，不少孩子为留守儿童，由祖父祖母看护，相互之间或与孩子父母意见不统一的情况难免发生，这可能导致了有关报道中所称的“孩子父母不知情”的情况。

In an interview,YaoGenGong said,TaiXing FenJieZhen, etc,Due to the migrant workers more,Many children for left-behind children,The grandmother and grandfather care,Each other or with the parents of the disagreements inevitably occurred,This can lead to the relevant reports have said"The child's parents don't know"situation.

　　“在泰兴，接种EV71疫苗后，与2011年当地手足口病发病数、重症数相比，2012年分别下降31.01%、60%。”江苏省疾控中心相关专家介绍。(记者姚雪青)

"In TaiXing,After the vaccine inoculation EV71,And 2011 local hand, foot and mouth disease incidence/Severe number compared with,2012 were down by 31.01%/60%."Jiangsu province CDC related experts.(Reporter YaoXueQing)