Today is 2020-08-11

A phase I/II clinical trial for inactivated novel coronavirus (2019-CoV) vaccine (Vero cells)
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注册号:

Registration number:

ChiCTR2000032459 

最近更新日期:

Date of Last Refreshed on:

2020-05-04 

注册时间:

Date of Registration:

2020-04-29 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

新型冠状病毒(2019-CoV)灭活疫苗(Vero细胞)Ⅰ/Ⅱ期临床试验 

Public title:

A phase I/II clinical trial for inactivated novel coronavirus (2019-CoV) vaccine (Vero cells)  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

评价新型冠状病毒灭活疫苗(2019-CoV)(Vero细胞)在3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 (2019-CoV) vaccine (Vero cells) in healthy population aged 3 years and above: a randomized, double-blind, placebo parallel-controlled phase I/II clinical trial 

研究课题代号(代码):

Study subject ID:

 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

 

申请注册联系人:

王伟 

研究负责人:

王彦霞 

Applicant:

Wei Wang 

Study leader:

Yanxia Wang 

申请注册联系人电话:

Applicant telephone:

+86 010-60963099 

研究负责人电话:

Study leader's telephone:

+86 13613816598 

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:

nvsiclinicaltrials@163.com 

研究负责人电子邮件:

Study leader's E-mail:

wangyanxia99@163.com 

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:

北京市北京经济技术开发区博兴二路6号 

研究负责人通讯地址:

河南省郑州市郑东新区农业南路105号 

Applicant address:

6 Second Boxing Road, Beijing Economic and Technological Development Area, Beijing, China 

Study leader's address:

105 Agricultural Road South, Zhengdong New District, Zhengzhou, He'nan, China 

申请注册联系人邮政编码:

Applicant postcode:

100176 

研究负责人邮政编码:

Study leader's postcode:

450016 

申请人所在单位:

北京生物制品研究所有限责任公司 

Applicant's institution:

Beijing 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-001-02 

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:

2013-08-26 

伦理委员会联系人:

许汴利 

Contact Name of the ethic committee:

Bianli Xu 

伦理委员会联系地址:

河南省郑州市郑东新区农业南路105号 

Contact Address of the ethic committee:

105 Agricultural Road South, Zhengdong New District, Zhengzhou, He'nan, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

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南路105号 

Primary sponsor's address:

105 Agricultural Road South, 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):

北京

市(区县):

北京

Country:

China

Province:

Beijing

City:

Beijing

单位(医院):

北京生物制品研究所有限责任公司

具体地址:

北京市北京经济技术开发区博兴二路6号

Institution
hospital:

Beijing Institute of Biological Products Co., LTD.

Address:

6 Second Boxing Road, Beijing Economic and Technological Development Area

经费或物资来源:

中国科学技术部 

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 inactivated SARS-CoV-2 vaccine (Vero cells) in healthy population at different ages after inoculation with different doses of inactivated SARS-CoV-2 vaccine (Vero cells), and to preliminarily explore the immunogenicity and persistence of inactivated SARS-CoV-2 vaccine (Vero cells).  

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1、年龄范围:3 岁及以上健康人群; 2、询问病史和体格检查,经研究者判断健康状况良好; 3、2019年12月至今,未去过湖北、境外或者出现过疫情的村/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; 4、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。 5、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; 6、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. Healthy subjects aged 3 years and above; 2. By asking for a medical history and a physical examination, the researchers determined that the subjects were in good health; 3. From December 2019 to now, the subject has not been to hubei province, outside the country or in a village/community where there has been an outbreak. The subject has not been exposed to a person infected with or suspected of COVID-19; 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. The subject or/and his/her legal guardian or trustee have the ability to understand the study procedures, voluntarily sign informed consent with informed consent, and comply with the requirements of the clinical study protocol. 

排除标准:

1、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”); 2、新型冠状病毒抗体检测阳性; 3、有SARS病毒感染史(自报,现场问询); 4、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; 5、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); 6、接种前腋下体温>37.0℃; 7、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; 8、有惊厥、癫痫、脑病或精神疾病史或家族史; 9、先天畸形或发育障碍,遗传缺陷,严重营养不良等; 10、严重的肝肾疾病、药物不可控制的高血压(收缩压≥140mmHg,舒张压≥90mmHg)、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; 11、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; 12、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、皮肤病、恶性肿瘤; 13、有凝血功能异常史(如凝血因子缺乏,凝血性疾病); 14、正在接受抗-TB治疗; 15、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); 16、接种前14天接种过减毒活疫苗,接种前7天内接受过其他疫苗; 17、接种前3个月内接受过血液制品; 18、接种前6个月内接受过其他研究药物; 19、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. Positive in serum antibodies (IgG and IgM) screening of COVID-19; 3. Has a history of SARS virus infection (self-reported, site information); 4. 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; 5. 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); 6. Armpit temperature > 37.0 degree C before administration; 7. 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; 8. History of convulsion, epilepsy, encephalopathy or mental illness or family history; 9. with congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.; 10. 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; 11. diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases; 12. with known or suspected diseases include: severe respiratory diseases, severe cardiovascular diseases, liver and kidney diseases, malignant tumors; 13. with history of coagulation dysfunction (e.g. Coagulation factor deficiency, coagulation disease); 14. Receiving anti-TB treatment; 15. Receiving immunotherapy or inhibitor therapy within 3 months (consistently oral or infusion for more than 14 days); 16. vaccinated with live attenuated vaccine within 1 month, or other vaccine within 14 days before vaccination; 17. Receiving blood products within 3 months before administration; 18. Receiving other research drugs within 6 months before vaccination; 19. The investigators determined that other conditions were inappropriate for the study.  

研究实施时间:

Study execute time:

From2020-04-28To 2021-11-28 

征募观察对象时间:

Recruiting time:

From2020-04-29To 2020-11-28 

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 dosage

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:

medium dosage

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 dosage

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 dosage

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:

medium dosage

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 dosage

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:

Ⅰ期G1

样本量:

24

Group:

Phase I G1

Sample size:

干预措施:

低剂量

干预措施代码:

Intervention:

low dosage

Intervention code:

组别:

Ⅰ期G2

样本量:

8

Group:

Phase I G2

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

placebo

Intervention code:

组别:

Ⅰ期G3

样本量:

24

Group:

Phase I G3

Sample size:

干预措施:

中剂量

干预措施代码:

Intervention:

medium dosage

Intervention code:

组别:

Ⅰ期G4

样本量:

8

Group:

Phase I G4

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

placebo

Intervention code:

组别:

Ⅰ期G5

样本量:

24

Group:

Phase I G5

Sample size:

干预措施:

高剂量

干预措施代码:

Intervention:

high dosage

Intervention code:

组别:

Ⅰ期G6

样本量:

8

Group:

Phase I G6

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

placebo

Intervention code:

组别:

Ⅰ期H1

样本量:

24

Group:

Phase I H1

Sample size:

干预措施:

低剂量

干预措施代码:

Intervention:

low dosage

Intervention code:

组别:

Ⅰ期H2

样本量:

8

Group:

Phase I H2

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

placebo

Intervention code:

组别:

Ⅰ期H3

样本量:

24

Group:

Phase I H3

Sample size:

干预措施:

中剂量

干预措施代码:

Intervention:

medium dosage

Intervention code:

组别:

Ⅰ期H4

样本量:

8

Group:

Phase I H4

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

placebo

Intervention code:

组别:

Ⅰ期H5

样本量:

24

Group:

Phase I H5

Sample size:

干预措施:

高剂量

干预措施代码:

Intervention:

high dosage

Intervention code:

组别:

Ⅰ期H6

样本量:

8

Group:

Phase I H6

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

placebo

Intervention code:

组别:

Ⅰ期M1

样本量:

24

Group:

Phase I M1

Sample size:

干预措施:

低剂量

干预措施代码:

Intervention:

low dosage

Intervention code:

组别:

Ⅰ期M2

样本量:

8

Group:

Phase I M2

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

placebo

Intervention code:

组别:

Ⅰ期M3

样本量:

24

Group:

Phase I M3

Sample size:

干预措施:

中剂量

干预措施代码:

Intervention:

medium dosage

Intervention code:

组别:

Ⅰ期M4

样本量:

8

Group:

Phase I M4

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

placebo

Intervention code:

组别:

Ⅰ期M5

样本量:

24

Group:

Phase I M5

Sample size:

干预措施:

高剂量

干预措施代码:

Intervention:

high dosage

Intervention code:

组别:

Ⅰ期M6

样本量:

8

Group:

Phase I M6

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 dosage

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:

medium

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 dosage

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:

medium

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:

medium dosage

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D1

样本量:

84

Group:

phase II D1

Sample size:

干预措施:

中剂量

干预措施代码:

Intervention:

medium dosage

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:

84

Group:

phase II E1

Sample size:

干预措施:

高剂量

干预措施代码:

Intervention:

high dosage

Intervention code:

组别:

Ⅱ期E2

样本量:

28

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 dosage

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:

medium dosage

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 dosage

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:

组别:

Ⅱ期G1

样本量:

60

Group:

phase II G1

Sample size:

干预措施:

低剂量

干预措施代码:

Intervention:

low dosage

Intervention code:

组别:

Ⅱ期G2

样本量:

20

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G3

样本量:

60

Group:

phase II G3

Sample size:

干预措施:

中剂量

干预措施代码:

Intervention:

medium dosage

Intervention code:

组别:

Ⅱ期G4

样本量:

20

Group:

phase II G4

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

placebo

Intervention code:

组别:

Ⅱ期G5

样本量:

60

Group:

phase II G5

Sample size:

干预措施:

高剂量

干预措施代码:

Intervention:

high dosage

Intervention code:

组别:

Ⅱ期G6

样本量:

20

Group:

phase II G6

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

placebo

Intervention code:

组别:

Ⅱ期H1

样本量:

60

Group:

phase II H1

Sample size:

干预措施:

低剂量

干预措施代码:

Intervention:

low dosage

Intervention code:

组别:

Ⅱ期H2

样本量:

20

Group:

phase II H1

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

placebo

Intervention code:

组别:

Ⅱ期H3

样本量:

60

Group:

phase II H3

Sample size:

干预措施:

中剂量组

干预措施代码:

Intervention:

medium dosage

Intervention code:

组别:

Ⅱ期H4

样本量:

20

Group:

phase II H4

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

placebo

Intervention code:

组别:

Ⅱ期H5

样本量:

60

Group:

phase II H5

Sample size:

干预措施:

高剂量

干预措施代码:

Intervention:

high dosage

Intervention code:

组别:

Ⅱ期H6

样本量:

20

Group:

phase II H6

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

placebo

Intervention code:

组别:

Ⅱ期M1

样本量:

60

Group:

phase II M1

Sample size:

干预措施:

低剂量

干预措施代码:

Intervention:

low dosage

Intervention code:

组别:

Ⅱ期M2

样本量:

20

Group:

phase II M2

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

placebo

Intervention code:

组别:

Ⅱ期M3

样本量:

60

Group:

phase II M3

Sample size:

干预措施:

中剂量

干预措施代码:

Intervention:

medium dosage

Intervention code:

组别:

Ⅱ期M4

样本量:

20

Group:

phase II M4

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

placebo

Intervention code:

组别:

Ⅱ期M5

样本量:

60

Group:

phase II M5

Sample size:

干预措施:

高剂量

干预措施代码:

Intervention:

high dosage

Intervention code:

组别:

Ⅱ期M6

样本量:

20

Group:

phase II M6

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):

商丘 

Country:

China 

Province:

He'nan 

City:

Shangqiu 

单位(医院):

梁园区疾病预防控制中心 

单位级别:

 

Institution
hospital:

Liangyuan district centers for disease control and prevention  

Level of the institution:

 

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:

Incidence of adverse reactions/events

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 SARS-CoV-2

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 SARS-CoV-2 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:

4 days before and 14 days after each dose, 21 days after the first dose, and 28, 90, 180 and 360 days after the full course in phase Ⅰgroup aged 18-59 years old

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 SARS-CoV-2 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:

Four days before and after each dose, 14 days after the first and second dose, and 28, 90, 180 and 360 days after the full vaccination in phase I groups aged 3-17 years old and ≥60 years old

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:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血样

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:

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 3 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)

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

Using Stata 12.0 software to generate random codes by randomization, the study vaccine and the placebo were randomly assigned to serial Numbers (each vaccine has a unique serial number).

盲法:

未说明

Blinding:

Not stated

原始数据公开时间:

The time of sharing IPD:

Within six months after the trial complete

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

ResMan临床试验公共管理平台

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

ResMan (www.medresman.org)

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

电子采集和管理系统

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

Electronic Data Capture(EDC)

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-04-29
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