ChiCTR2000031809 版本V1.8 版本创建时间2020/4/12 22:41:39 中国临床试验注册中心

审核状态:

Project audit state:

通过审核

Successful

注册号:

Registration number:

ChiCTR2000031809 

最近更新时间:

Date of Last Refreshed on:

2020/4/11 15:33:24 

注册号状态:

预注册  

Registration Status:

Prospective registration  

填写语言:

中文和英文  

Language:

Chinese And English  

注册题目:

新型冠状病毒(COVID-19)灭活疫苗(Vero细胞)随机、双盲、安慰剂平行对照Ⅰ/Ⅱ期临床试验 

Public title:

A randomized, double-blind, placebo parallel-controlled phase I/II clinical trial for inactivated Novel Coronavirus Pneumonia (COVID-19) vaccine (Vero cells)  

注册题目简写:

 

Public title acronym:

 

研究课题的正式科学名称:

评价新型冠状病毒灭活疫苗(Vero细胞)在6岁及以上健康人群中接种的安全性和免疫原性的随机、双盲、安慰剂平行对照Ⅰ/Ⅱ期临床试验 

Scientific title:

Evaluation of the safety and immunogenicity of inactivated Novel Coronavirus Pneumonia (COVID-19) vaccine (Vero cells) in healthy population aged 6 years and above in a randomized, double-blind, placebo parallel-controlled phase I/II clinical trial 

研究课题的正式科学名称简写:

 

Scientific title acronym:

 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

陈伟 

研究负责人:

夏胜利 

Applicant:

Wei Chen 

Study leader:

Shengli Xia 

申请注册联系人电话:

Applicant telephone:

+86 027 88862194 

研究负责人电话:

Study leader's telephone:

+86 13592610137 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

564890016@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

xiasl@hncdc.com.cn 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

湖北省武汉市江夏区郑店黄金工业园路1号 

研究负责人通讯地址:

河南省郑州市郑东新区农业东路 

Applicant address:

1 Golden Industrial Park Road, Zhengdian, Jiangxia District,Wuhan City, Hubei Province, P.R.China 

Study leader's address:

Agricultural East, Zhengdong New District, Zhengzhou, He'nan, China 

申请注册联系人邮政编码:

Applicant postcode:

430207 

研究负责人邮政编码:

Study leader's postcode:

450016 

申请人所在单位:

武汉生物制品研究所有限责任公司 

Applicant's institution:

Wuhan Institute of Biological Products co., LTD. 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

2020-YM-002-02 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

河南省疾病预防控制中心医学伦理委员会 

Name of the ethic committee:

Medical Ethics Commission of Henan Provincial Center for Disease Control and Prevention  

伦理委员会批准日期:

Date of approved by ethic committee:

2020-04-10 

国家FDA批准文号:

Approved No. of SFDA:

国家FDA批准附件:

Approved file of SFDA:

国家FDA批准日期:

Date of approved by SFDA:

研究实施负责(组长)单位:

河南省疾病预防控制中心 

Primary sponsor:

Henan Provincial Center for Disease Control and Prevention  

研究实施负责(组长)单位地址:

河南省郑州市郑东新区农业东路 

Primary sponsor's address:

Agricultural East, Zhengdong New District, Zhengzhou, He'nan, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

湖北

市(区县):

武汉

Country:

China

Province:

Hubei

City:

Wuhan

单位(医院):

武汉生物制品研究所有限责任公司

具体地址:

湖北省武汉市江夏区郑店黄金工业园路1号

Institution
hospital:

Wuhan institute of biological products co.,LTD.

Address:

1 Golden Industrial Park Road, Zhengdian, Jiangxia District

国家:

中国

省(直辖市):

湖北

市(区县):

武汉

Country:

China

Province:

Hubei

City:

Wuhan

单位(医院):

中国科学院武汉病毒研究所

具体地址:

湖北省武汉市武昌区小洪山中区44号

Institution
hospital:

Wuhan Institute of Virology, Chinese Academy of Sciences (CAS)

Address:

44 Xiaohongshan Central District, Wuchang District

经费或物资来源:

国家科技部 

Source(s) of funding:

Ministry of Science and Technology, China 

研究疾病:

新型冠状病毒肺炎(COVID-19) 

Target disease:

Novel Coronavirus Pneumonia (COVID-19)  

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

I期+II期 

Study phase:

1-2 

研究目的:

通过对不同年龄人群接种不同剂量新型冠状病毒灭活疫苗(Vero细胞)后的观察,评价新型冠状病毒灭活疫苗(Vero细胞)在相应年龄健康人群中的安全性,并初步探索免疫原性和持久性。 

Objectives of Study:

To evaluate the safety of COVID-19 vaccine (Vero cells) in healthy people at different ages after inoculation with different doses of COVID-19 vaccine (Vero cells), and to preliminarily explore the immunogenicity and persistence of COVID-19 vaccine (Vero cells) in healthy people. 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

-年龄范围:6岁及以上健康人群; -询问病史和体格检查,经研究者判断健康状况良好; -从2019年12月至今未去过湖北、境外及出现过疫情的村/社区,未接触新型冠状病毒感染者或疑似病例,处于非隔离期内的人员,且同村/社区内未出现新型冠状病毒感染者或疑似病例; -育龄女性受试者入组时没有怀孕(尿妊娠试验阴性)、未在哺乳期且在入组后的前3个月内无生育计划;在入选前2周内已采取有效的避孕措施; -在整个研究随访期间(约14个月),能够且愿意完成整个规定研究计划; -本人或/和其法定监护人或受托人有能力了解研究程序,经知情同意,自愿签署知情同意书,能够遵守临床研究方案的要求。 

Inclusion criteria

1. Age scope: Healthy subjects aged 6 years and above; 2. Request medical history and physical examination, and the researchers judged health status of subjects; 3. Since December 2019, subjects have not been to Hubei, overseas and villages/communities with COVID-19 epidemic, and do not contact with COVID-19 cases or suspected cases. Subject shall be not in guarantee, and there are not COVID-19 cases or suspected cases in their village and communities; 4. Female subjects with childbearing age are not pregnant at the time of admission (negative reaction in urine pregnancy test), and are not nursing and have not fertility plan within the first 3 months after admission. Effective contraceptive measures shall be taken within 2 weeks before inclusion; 5. Subjects are able and willing to complete the study plan over follow-up period of approximately 14 months. 6. I or/and my legal guardian or trustee have the capability to understand the research procedures, sign informed consent form voluntarily with informed consent, and be able to comply with the requirements of the clinical research plan. 

排除标准:

-新型冠状病毒感染确诊病例疑似病例者或无症状感染者(查询中国疾病预防控制信息系统) -新型冠状病毒抗体检测阳性 -接种前14天内出现发热(腋温>37.0℃)、干咳、乏力、鼻塞、流涕、咽痛、肌痛、腹泻、呼吸急促、呼吸困难症状者; -接种前检测血生化、血常规、尿常规相关指标有临床意义的异常者(仅指Ⅰ期); -接种前腋下体温>37.0℃; -既往发生过疫苗接种严重过敏反应(如急性过敏反应、荨麻疹、皮肤湿疹、呼吸困难、血管神经性水肿或腹痛)或对新型冠状病毒灭活疫苗已知成份过敏; -有惊厥、癫痫、脑病或精神疾病史或家族史; -先天畸形或发育障碍,遗传缺陷,严重营养不良等; -严重的肝肾疾病、药物不可控制的高血压(收缩压≥140mmHg,舒张压≥90 mmHg)、糖尿病并发症、恶性肿瘤、各种急性疾病或慢性疾病急性发作期; -已被诊断为患有先天性或获得性免疫缺陷、HIV感染、淋巴瘤、白血病或其他自身免疫疾病; -已知或怀疑患有疾病包括:严重呼吸系统疾病、严重心血管疾病、肝肾疾病、恶性肿瘤; -有凝血功能异常史(如凝血因子缺乏,凝血性疾病); -正在接受抗-TB治疗; -3个月内接受免疫增强或抑制剂治疗者(持续口服或滴注超过14天); -接种前1个月内接种过减毒活疫苗,接种前14天内接种过其他疫苗; -接种前3个月内接受过血液制品; -接种前6个月内接受过其他研究药物; -研究者判断其他不适合参加本临床试验的情况 

Exclusion criteria:

1. Confirmed cases, suspected cases or asymptomatic cases with COVID-19 (refer to Information System of China Disease Prevention and Control); 2. COVID-19 antibody test positive; 3. Fever (armpit temperature > 37.0 degree C), dry cough, fatigue, nasal obstruction, runny nose, sore throat, myalgia, diarrhea, shortness of breath and dyspnea within 14 days before administration; 4. Subjects with abnormal indicators, such as blood biochemistry, blood routine and urine routine, which might show clinical meaning, before administration (only refers to Phase I); 5. Armpit temperature > 37.0 degree C before administration; 6. Subjects with history of severe allergic reactions (such as acute anaphylaxis, urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain) or allergy to known composition of COVID-19 vaccine; 7. Subjects with history of convulsion, epilepsy, encephalopathy or mental illness or family history; 8. Subjects with congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.; 9. Subjects with severe liver and kidney diseases, uncontrollable hypertension (systolic pressure >=140 mmHg, diastolic pressure >=90 mmHg), diabetic complications, malignant tumors, various acute diseases or acute onset of chronic diseases; 10. Subjects diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases; 11. Subjects with known or suspected diseases include: severe respiratory diseases, severe cardiovascular diseases, liver and kidney diseases, malignant tumors; 12. Subjects with history of coagulation dysfunction (e.g. Coagulation factor deficiency, coagulation disease); 13. Subjects receiving anti-TB treatment; 14. Subjects receiving immunotherapy or inhibitor therapy within 3 months (consistently oral or infusion for more than 14 days); 15. Subjects vaccinated with live attenuated vaccine within 1 month, or other vaccine within 14 days before vaccination; 16. Subjects receiving blood products within 3 months before administration; 17. Subjects receiving other research drugs within 6 months before vaccination; 18. The researchers shall judge the other conditions which might be not in compliance with the reequipments of this clinical trial. 

研究实施时间:

Study execute time:

From2020-04-11To 2021-11-10 

干预措施:

Interventions:

组别:

Ⅰ期A1

样本量:

24

Group:

phase I A1

Sample size:

干预措施:

低剂量

干预措施代码:

Intervention:

Low dose

Intervention code:

组别:

Ⅰ期A2

样本量:

8

Group:

phase I A2

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

Placebo

Intervention code:

组别:

Ⅰ期A3

样本量:

24

Group:

phase I A3

Sample size:

干预措施:

中剂量

干预措施代码:

Intervention:

Middle dose

Intervention code:

组别:

Ⅰ期A4

样本量:

8

Group:

phase I A4

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

Placebo

Intervention code:

组别:

Ⅰ期A5

样本量:

24

Group:

phase I A5

Sample size:

干预措施:

高剂量

干预措施代码:

Intervention:

High dose

Intervention code:

组别:

Ⅰ期A6

样本量:

8

Group:

phase I A6

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

Placebo

Intervention code:

组别:

Ⅰ期E1

样本量:

24

Group:

phase I E1

Sample size:

干预措施:

低剂量

干预措施代码:

Intervention:

Low dose

Intervention code:

组别:

Ⅰ期E2

样本量:

8

Group:

phase I E2

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

Placebo

Intervention code:

组别:

Ⅰ期E3

样本量:

24

Group:

phase I E3

Sample size:

干预措施:

中剂量

干预措施代码:

Intervention:

Middle dose

Intervention code:

组别:

Ⅰ期E4

样本量:

8

Group:

phase I E4

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

Placebo

Intervention code:

组别:

Ⅰ期E5

样本量:

24

Group:

phase I E5

Sample size:

干预措施:

高剂量

干预措施代码:

Intervention:

High dose

Intervention code:

组别:

Ⅰ期E6

样本量:

8

Group:

phase I E6

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

Placebo

Intervention code:

组别:

Ⅰ期F1

样本量:

24

Group:

phase I F1

Sample size:

干预措施:

低剂量

干预措施代码:

Intervention:

Low dose

Intervention code:

组别:

Ⅰ期F2

样本量:

8

Group:

phase I F2

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

Placebo

Intervention code:

组别:

Ⅰ期F3

样本量:

24

Group:

phase I F3

Sample size:

干预措施:

中剂量

干预措施代码:

Intervention:

Middle dose

Intervention code:

组别:

Ⅰ期F4

样本量:

8

Group:

phase I F4

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

Placebo

Intervention code:

组别:

Ⅰ期F5

样本量:

24

Group:

phase I F5

Sample size:

干预措施:

高剂量

干预措施代码:

Intervention:

High dose

Intervention code:

组别:

Ⅰ期F6

样本量:

8

Group:

phase I F6

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

Placebo

Intervention code:

组别:

Ⅱ期A1

样本量:

60

Group:

phase II A1

Sample size:

干预措施:

低剂量

干预措施代码:

Intervention:

Low dose

Intervention code:

组别:

Ⅱ期A2

样本量:

20

Group:

phase II A2

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

Placebo

Intervention code:

组别:

Ⅱ期A3

样本量:

60

Group:

phase II A3

Sample size:

干预措施:

中剂量

干预措施代码:

Intervention:

Middle dose

Intervention code:

组别:

Ⅱ期A4

样本量:

20

Group:

phase II A4

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

Placebo

Intervention code:

组别:

Ⅱ期A5

样本量:

60

Group:

phase II A5

Sample size:

干预措施:

高剂量

干预措施代码:

Intervention:

High dose

Intervention code:

组别:

Ⅱ期A6

样本量:

20

Group:

phase II A6

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

Placebo

Intervention code:

组别:

Ⅱ期B1

样本量:

84

Group:

phase II B1

Sample size:

干预措施:

中剂量

干预措施代码:

Intervention:

Middle dose

Intervention code:

组别:

Ⅱ期B2

样本量:

28

Group:

phase II B2

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

Placebo

Intervention code:

组别:

Ⅱ期C1

样本量:

84

Group:

phase II C1

Sample size:

干预措施:

中剂量

干预措施代码:

Intervention:

Middle dose

Intervention code:

组别:

Ⅱ期C2

样本量:

28

Group:

phase II C2

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

Placebo

Intervention code:

组别:

Ⅱ期G1

样本量:

84

Group:

phase II G1

Sample size:

干预措施:

中剂量

干预措施代码:

Intervention:

Middle dose

Intervention code:

组别:

Ⅱ期G2

样本量:

28

Group:

phase II G2

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

Placebo

Intervention code:

组别:

Ⅱ期D1

样本量:

84

Group:

phase II D1

Sample size:

干预措施:

高剂量

干预措施代码:

Intervention:

High dose

Intervention code:

组别:

Ⅱ期D2

样本量:

28

Group:

phase II D2

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

Placebo

Intervention code:

组别:

Ⅱ期E1

样本量:

60

Group:

phase II E1

Sample size:

干预措施:

低剂量

干预措施代码:

Intervention:

Low dose

Intervention code:

组别:

Ⅱ期E2

样本量:

20

Group:

phase II E2

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

Placebo

Intervention code:

组别:

Ⅱ期E3

样本量:

60

Group:

phase II E3

Sample size:

干预措施:

中剂量

干预措施代码:

Intervention:

Middle dose

Intervention code:

组别:

Ⅱ期E4

样本量:

20

Group:

phase II E4

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

Placebo

Intervention code:

组别:

Ⅱ期E5

样本量:

60

Group:

phase II E5

Sample size:

干预措施:

高剂量

干预措施代码:

Intervention:

High dose

Intervention code:

组别:

Ⅱ期E6

样本量:

20

Group:

phase II E6

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

Placebo

Intervention code:

组别:

Ⅱ期F1

样本量:

60

Group:

phase II F1

Sample size:

干预措施:

低剂量

干预措施代码:

Intervention:

Low dose

Intervention code:

组别:

Ⅱ期F2

样本量:

20

Group:

phase II F2

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

Placebo

Intervention code:

组别:

Ⅱ期F3

样本量:

60

Group:

phase II F3

Sample size:

干预措施:

中剂量

干预措施代码:

Intervention:

Middle dose

Intervention code:

组别:

Ⅱ期F4

样本量:

20

Group:

phase II F4

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

Placebo

Intervention code:

组别:

Ⅱ期F5

样本量:

60

Group:

phase II F5

Sample size:

干预措施:

高剂量

干预措施代码:

Intervention:

High dose

Intervention code:

组别:

Ⅱ期F6

样本量:

20

Group:

phase II F6

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

Placebo

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

河南 

市(区县):

焦作 

Country:

China 

Province:

He'nan 

City:

Jiaozuo 

单位(医院):

武陟县疾病预防控制中心 

单位级别:

 

Institution
hospital:

Wuzhi County Center for Disease Control and Prevention  

Level of the institution:

 

国家:

中国 

省(直辖市):

河南 

市(区县):

焦作 

Country:

China 

Province:

He'nan 

City:

Jiaozuo 

单位(医院):

武陟县人民医院 

单位级别:

二级医院 

Institution
hospital:

People’s hospital, Wuzhi county  

Level of the institution:

Secondary Hospital 

测量指标:

Outcomes:

指标中文名:

不良反应/事件的发生率

指标类型:

主要指标 

Outcome:

Incidence of adverse reactions/events

Type:

Primary indicator 

测量时间点:

每剂接种后0-7天

测量方法:

Measure time point of outcome:

0-7 days after each dose of vaccination

Measure method:

指标中文名:

肝肾功能、血常规、尿常规异常指标发生率

指标类型:

次要指标 

Outcome:

Incidence of abnormal indicators of liver and kidney function, blood routine and urine routine

Type:

Secondary indicator 

测量时间点:

Ⅰ期受试者每剂疫苗接种后第4天

测量方法:

Measure time point of outcome:

The 4th day after each dose of vaccination in phase I

Measure method:

指标中文名:

不良反应/事件的发生率

指标类型:

次要指标 

Outcome:

Rate of adverse reaction and adverse event

Type:

Secondary indicator 

测量时间点:

每剂疫苗接种后8~28/30天、0~28/30天

测量方法:

Measure time point of outcome:

8-28/30 days, 0-28/30 days after inoculation of each dose of vaccine

Measure method:

指标中文名:

严重不良事件( SAE)的发生率

指标类型:

次要指标 

Outcome:

Incidence of Serious Adverse Events (SAE)

Type:

Secondary indicator 

测量时间点:

首剂接种开始至全程免疫后 12个月内

测量方法:

Measure time point of outcome:

Within 12 months from first vaccination to completion of full vaccination schedule

Measure method:

指标中文名:

抗新型冠状病毒血清抗体4倍增长率和抗体水平(GMT、GMI)

指标类型:

次要指标 

Outcome:

Four-fold growth rate and antibody level (GMT, GMI) of serum antibody against COVID-19

Type:

Secondary indicator 

测量时间点:

全程免疫后28天

测量方法:

Measure time point of outcome:

28 days after full vaccination

Measure method:

指标中文名:

新型冠状病毒抗体4倍增长率和抗体水平(GMT、GMI)

指标类型:

次要指标 

Outcome:

Four-fold growth rate and antibody level (GMT, GMI) of COVID-19 antibody

Type:

Secondary indicator 

测量时间点:

Ⅰ期18-59岁组每剂免前、免后4天、14天,首剂免后21天,全程免后28天、90天、180天、360天

测量方法:

Measure time point of outcome:

In the 18-59 age group, bleeding shall be done at 4 and 14 days before and after each dose of vaccination, 21 days after the first dose of vaccination, 28, 90, 180 days after full vaccination completion, and 360 days after full vaccination in phase Ⅰ

Measure method:

指标中文名:

新型冠状病毒抗体4倍增长率和抗体水平(GMT、GMI)

指标类型:

次要指标 

Outcome:

Four-fold growth rate and antibody level (GMT, GMI) of COVID-19 antibody

Type:

Secondary indicator 

测量时间点:

Ⅰ期 ≥60岁和 6-17岁每剂免前、免后4天,首剂和2剂免后14天,全程免后28天、90天、180天、360天

测量方法:

Measure time point of outcome:

In >=60 years old and 6-17 years old groups, bleeding shall be done before and 4 days after each dose of vaccination, 14 days after the first and second doses of vaccination, at 28 days and 90 days and 180 days and 360 days after full vaccination in phase Ⅰ

Measure method:

指标中文名:

细胞免疫

指标类型:

次要指标 

Outcome:

Cellular immunity

Type:

Secondary indicator 

测量时间点:

Ⅰ期18岁及以上年龄组首剂和第2剂每剂免前、免后14天,第3剂免前、全程免疫后28天、180天、360天

测量方法:

Measure time point of outcome:

For the group at 18 years old and above, bleeding shall be done before and after first and second vaccination, before third vaccination and at 28 days, 180 days and 360 days after full vaccination in phase I

Measure method:

指标中文名:

不良反应/事件的发生率

指标类型:

次要指标 

Outcome:

Incidence of adverse reactions/events

Type:

Secondary indicator 

测量时间点:

Ⅱ期受试者每剂疫苗接种后8~14/21/28/30天、0~14/21/28/30天

测量方法:

Measure time point of outcome:

8-14/21/28/30 days, 0-14/21/28/30 days after inoculation of each dose of vaccine in phase II

Measure method:

指标中文名:

新型冠状病毒抗体4倍增长率和抗体水平(GMT、GMI)

指标类型:

次要指标 

Outcome:

Four-fold growth rate and antibody level (GMT, GMI) of COVID-19 antibody

Type:

Secondary indicator 

测量时间点:

Ⅱ期18~59岁1剂组和2剂组免前、全程免疫28天后

测量方法:

Measure time point of outcome:

In 18-59 age group with 1 dose, bleeding shall be done before vaccination and at 28 days post full-vaccination completion in phase II

Measure method:

指标中文名:

新型冠状病毒抗体4倍增长率和抗体水平(GMT、GMI)

指标类型:

次要指标 

Outcome:

Four-fold growth rate and antibody level (GMT, GMI) of COVID-19 antibody

Type:

Secondary indicator 

测量时间点:

Ⅱ期3剂组每剂免前和全程免疫28天后

测量方法:

Measure time point of outcome:

In 3-doses group, bleeding shall be done before each dose and at 28 days post full vaccination in phase II

Measure method:

指标中文名:

新型冠状病毒抗体4倍增长率和抗体水平(GMT、GMI)

指标类型:

次要指标 

Outcome:

Four-fold growth rate and antibody level (GMT, GMI) of COVID-19 antibody

Type:

Secondary indicator 

测量时间点:

Ⅱ期全程免疫后90天、180天和360天

测量方法:

Measure time point of outcome:

90 days, 180 days and 360 days after full vaccination in phase II

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

Blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

外周血淋巴细胞

组织:

Sample Name:

PBMC

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

尿液

组织:

Sample Name:

Urine

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

尚未开始

Pending

年龄范围:

Participant age:

最小 Min age 6 years
最大 Max age years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

,应用Stata 12.0软件以随机化方法产生随机编码,将试验疫苗和对照疫苗随机编成序列号(每人份疫苗有唯一的序列号)。考虑疫情紧急情况下局部揭盲的需要,分年龄组、剂量组和免疫程序组(Ⅱ期临床试验)分别进行编盲。在Ⅰ期临床试验中,将分9个亚组进行编盲,且9个亚组的随机种子数均不同;在Ⅱ期临床试验中,将分13个亚组进行编盲,且13个亚组的随机种子数均不同。

Randomization Procedure (please state who generates the random number sequence and by what method):

Stata 12.0 software will be used to generate random codes by randomization method, and the test vaccine and the control vaccine will be randomly compiled into serial numbers (each vaccine has a unique serial number). Considering the need of local blindness uncoveried

UTN(全球唯一识别码):

盲法:

双盲

Blinding:

Double blind

试验完成后的统计结果:

Calculated Results ater
the Study Completed:

研究负责(组长)单位:

Organizer institution (leader institution):

资料收集汇总单位:

6M

Data collection Institution:

资料管理单位:

ResMan临床试验公共管理平台

Data management Institution:

ResMan (www.medresman.org)

资料分析单位:

电子采集和管理系统(EDC)

Data analysis Institution:

Electronic Data Capture(EDC)

注册人:

Name on Registration:

 2020-04-11