Today is 2020-12-02

Randomized double blind, placebo controlled phase I trial for anti novel coronavirus pneumonia (COVID-19) recombinant vaccine (Sf9)
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注册号:

Registration number:

ChiCTR2000037518 

最近更新日期:

Date of Last Refreshed on:

2020-10-26 

注册时间:

Date of Registration:

2020-08-28 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

重组新型冠状病毒肺炎(COVID-19)疫苗(Sf9)I期临床试验研究 

Public title:

Randomized double blind, placebo controlled phase I trial for anti novel coronavirus pneumonia (COVID-19) recombinant vaccine (Sf9) 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

在18周岁及以上健康人群中开展重组新型冠状病毒肺炎(COVID-19)疫苗(Sf9细胞)的单中心、随机、组内双盲、安慰剂对照的Ⅰ期临床试验 

Scientific title:

Randomized double blind, placebo controlled phase I trial for anti novel coronavirus pneumonia (COVID-19) recombinant vaccine (Sf9) among health adults population 

研究课题代号(代码):

Study subject ID:

JSVCT098 

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:

王玮 

研究负责人:

朱凤才 

Applicant:

Wei Wang 

Study leader:

Fengcai Zhu 

申请注册联系人电话:

Applicant telephone:

+86 13679077022 

研究负责人电话:

Study leader's telephone:

+86 13951994867 

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:

weiwang@scu.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

jszfc@jscdc.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:

中国四川省成都市武侯区国学巷37号 

研究负责人通讯地址:

江苏省南京市江苏路172号 

Applicant address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, China 

Study leader's address:

172 Jiangsu Road, Nanjing, Jiangsu, China 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

四川大学华西医院 

Applicant's institution:

West China Hospital, Sichuan University 

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:

JSJK2020-A053-01 

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:

江苏省疾病预防控制中心伦理审查委员会 

Name of the ethic committee:

Ethics Committee of Jiangsu Provincial Center for Disease Prevention and Control 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-08-25 

伦理委员会联系人:

蔡慧媛 

Contact Name of the ethic committee:

Huiyuan Cai 

伦理委员会联系地址:

江苏省南京市江苏路172号 

Contact Address of the ethic committee:

172 Jiangsu Road, Nanjing, Jiangsu, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 25-83759406 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

ec@jscdc.cn 

研究实施负责(组长)单位:

四川大学华西医院 

Primary sponsor:

West China Hospital, Sichuan University 

研究实施负责(组长)单位地址:

成都市武侯区国学巷37号 

Primary sponsor's address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

自筹 

Source(s) of funding:

no funding 

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期临床试验 

Study phase:

研究目的:

评价18周岁及以上健康人群接种重组新型冠状病毒肺炎疫苗(Sf9细胞)的安全性、耐受性和免疫原性。 

Objectives of Study:

The aim is to evaluate safety, tolerability and immunogenicity of a recombinant SARS-CoV-2 vaccine (Sf9 cell) in Chinese healthy population aged 18 years and older. 

药物成份或治疗方案详述:

试验疫苗: 通用名称:重组新型冠状病毒肺炎疫苗(Sf9细胞) 研制单位:四川大学华西医院 规格:20μg/0.5ml/瓶 批号:20200508 有效期至:2021.11.02 包装:西林瓶 该疫苗以杆状病毒为载体,在Sf9细胞中表达新型冠状病毒SARS-CoV-2刺突蛋白(Spike protein, S)受体结合域RBD区(S-RBD),经抗原分离纯化,加入氢氧化铝佐剂制成,用于预防新型冠状病毒感染肺炎(COVID-19)。临床试验剂量设计为中、高2个剂量,分别为20μg(0.5ml)、40μg(1.0ml)。 安慰剂对照: 研制单位:四川大学华西医院 规格:0.5ml/瓶 批号:20200501-P 有效期至:2021.11.02 包装:西林瓶 除不含疫苗抗原外,其它成分均与试验疫苗一致,并经中国食品药品检定研究院检定合格。 

Description for medicine or protocol of treatment in detail:

Experimental vaccine: Common name: recombinant SARS-CoV-2 vaccine (Sf9 cell). Manufacturer: West China Hospital of Sichuan University. Specification: 20 μ g / 0.5ml/ bottle. Batch number: 20200508. Expiration Date: 2021.11.02. Packing: penicillin bottle. Using baculovirus as vector, the SARS-CoV-2 spike protein (Spike protein, S) receptor binding domain RBD (S-RBD) of novel coronavirus was expressed in Sf9 cells. The vaccine was isolated and purified and prepared with aluminum hydroxide adjuvant to prevent novel coronavirus from being infected with pneumonia (COVID-19). The clinical trial doses were designed as middle and high doses, 20 μ g (0.5ml) and 40 μ g (1.0ml), respectively. Placebo control: Manufacturer: West China Hospital of Sichuan University. Specification: 0.5ml/ bottle. Batch number: 20200501murp. Expiration Date: 2021.11.02. Packing: Xilin bottle. Except that there is no vaccine antigen, all the other components are consistent with the experimental vaccine and have been certified by the China Institute for Food and Drug Control. 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1. 年龄在18周岁及以上。 2. 获得受试者的知情同意,并签署知情同意书。 3. 受试者能够并愿意遵守临床试验方案的要求,并且能完成约13个月的研究随访。 4. HIV抗体筛查阴性。 5. 腋下体温≤37.0℃。 6. 2019新型冠状病毒核酸筛查阴性。 7. 2019新型冠状病毒抗体(IgG和IgM)筛查阴性。 8. 胸部CT无新型冠状病毒肺炎影像学特征。 9. BMI指数18.5-30.0。 10. 血常规、血生化、凝血功能、尿常规等实验室检查指标无显著异常,或经医生判定无临床意义(包括白细胞计数、淋巴细胞计数、中性粒细胞计数、血小板、血红蛋白、谷丙转氨酶ALT、谷草转氨酶AST、总胆红素、空腹血糖、肌酐、凝血酶原时间、部分活化凝血酶原时间、尿蛋白、尿红细胞)。 11. 经查问病史、体检和临床判定健康者,符合本制品免疫接种的受试者。 

Inclusion criteria

1. Male or female subjects aged >=18 years old at the recruitment; 2. The subject can provide with informed consent and signs and dates a written informed consent form (ICF) prior to the initiation of any trial procedures; 3. They must be able to understand and follow trial-related instructions. They must be willing and able to comply with planned visits, treatment schedule, laboratory tests and other requirements of the trial; 4. Negative in HIV antibody test; 5. Axillary temperature <=37.0 degrees C; 6. Negative finding in nucleic acid screening of SARS-CoV-2; 7. Negative in antibodies (IgG and IgM) test of SARS-CoV-2; 8. Negative finding in chest CT examine for COVID-19; 9. Body mass index (BMI) 18.5 to 30; 10. There were no significant abnormalities in blood routine, blood biochemistry, coagulation function and urine routine, or no clinical significance was determined by doctors (including white blood cell count, lymphocyte count, neutrophil count, platelet, hemoglobin, glutamic pyruvic transaminase ALT, glutamic oxaloacetic transaminase AST, total bilirubin, fasting blood glucose, creatinine, prothrombin time, partially activated prothrombin time, urine protein, urine red blood cells); 11. Healthy subjects who have been examined by medical history, physical examination and clinical examination are in accordance with the immunization of this vaccine. 

排除标准:

1 有惊厥、癫痫、脑病和精神病等病史或家族史者。 2 对研究疫苗中任何成份过敏者,过去有较严重的疫苗过敏反应,过敏史。 3 女性尿妊娠试验阳性者,怀孕、在哺乳期的妇女,或在6个月内有怀孕计划的妇女。 4 急性发热性疾病者及传染病者。 5 有SARS病史者。 6 患有较严重的心血管疾病,如心律失常、传导阻滞、心肌梗塞、严重高血压且药物无法控制等。 7 患有严重慢性疾病或病情处于进展期不能平稳控制,如哮喘、糖尿病、甲状腺疾病等。 8 先天或获得性的血管性水肿/神经性水肿。 9 接受试验疫苗前1年有患荨麻疹。 10 无脾或功能性无脾。 11 患血小板减少症或其他凝血障碍(可能造成肌肉注射禁忌)。 12 晕针者。 13 过去6个月内有过免疫抑制剂治疗、抗过敏治疗、细胞毒性治疗、吸入皮质类固醇(不包括过敏性鼻炎的皮质类固醇喷雾治疗,急性非并发皮炎的表面皮质类固醇治疗)。 14 接受试验疫苗前4个月内接受过血液制品。 15 接受试验疫苗前1个月内接受过其他研究药物。 16 接受试验疫苗前1个月内接受过减毒活疫苗。 17 接受试验疫苗前14天内接受过亚单位或灭活疫苗。 18 正在接受抗结核治疗。 19 根据研究者判断,由于各种医疗、心理、社会条件或其他条件,有悖于试验方案,或影响受试者签署知情同意的。 

Exclusion criteria:

Exclusion criteria of prime dose: 1. Subjects with a medical or family history of convulsions, epilepsy, encephalopathy, and psychosis; 2. Allergic to any ingredient in the study vaccine, or used to have a serious vaccine allergic reaction; 3. Women who are positive for urine pregnancy test. Women who are pregnant or breastfeeding or planning to be pregnant within 6 months; 4. Have acute febrile diseases or infectious diseases; 5. With history of SARS, SARS-CoV-2 or MERS infection; 6. People with serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension and can not control using drugs; 7. Patients with severe chronic diseases or progressive conditions can not be smoothly controlled, such as asthma, diabetes, and thyroid diseases; 8. Have congenital or acquired angioedema/neuroedema; 9. Had urticaria 1 year before receiving the study vaccine; 10. Asplenium or functional aspleen; 11. Have thrombocytopenia or other coagulation disorders (may cause contraindications to intramuscular injection); 12. Have acupuncture syncope reaction; 13. Have received immunosuppressant therapy, anti-allergic therapy, cytotoxic therapy, inhaled corticosteroids in the past 6 months (excluding corticosteroid spray therapy for allergic rhinitis, and surface corticosteroid therapy for acute non-complicated dermatitis); 14. Received blood products within 4 months before receiving the study vaccine; 15. Received other study drugs within 1 month before receiving the study vaccine; 16. Received a live attenuated vaccine within 1 month before receiving the study vaccine; 17. Received a subunit or inactivated vaccine within 14 days before receiving the study vaccine; 18. Are receiving anti-tuberculosis treatment; 19. According to the judgment of the researchers, due to a variety of medical, psychological, social or other conditions, it is contrary to the trial scheme, or affects the subjects to sign informed consent; 20. It is contrary to the trial protocol, or affects the subjects to sign informed consent due to various medical, psychological, social or other conditions, according to the investigators judgment. 

研究实施时间:

Study execute time:

From2020-08-28To 2021-08-28 

征募观察对象时间:

Recruiting time:

From2020-08-28To 2020-09-28 

干预措施:

Interventions:

组别:

1

样本量:

24

Group:

1

Sample size:

干预措施:

18-55岁,试验疫苗 中剂量 免疫程序 0,28天

干预措施代码:

Intervention:

Middle-dose vaccine for subjects aged 18-55 years (0, 28 day regimen)

Intervention code:

组别:

2

样本量:

18

Group:

2

Sample size:

干预措施:

大于55岁,试验疫苗 中剂量 免疫程序 0,28天

干预措施代码:

Intervention:

Middle-dose vaccine for subjects aged > 55 years (0, 28 day regimen)

Intervention code:

组别:

3

样本量:

24

Group:

3

Sample size:

干预措施:

18-55岁,试验疫苗 高剂量 免疫程序 0,28天

干预措施代码:

Intervention:

Middle-dose vaccine for subjects aged 18 to 55 years (0, 28 day regimen)

Intervention code:

组别:

4

样本量:

18

Group:

4

Sample size:

干预措施:

大于55岁,试验疫苗 高剂量 免疫程序 0,28天

干预措施代码:

Intervention:

High-dose vaccine for subjects aged > 55 years (0, 28 day regimen)

Intervention code:

组别:

5

样本量:

24

Group:

5

Sample size:

干预措施:

18-55岁,试验疫苗 高剂量 免疫程序 0,14,28

干预措施代码:

Intervention:

High-dose vaccine for subjects aged 18-55 years (0, 14, 28 day regimen)

Intervention code:

组别:

6

样本量:

18

Group:

6

Sample size:

干预措施:

大于55岁,试验疫苗 高剂量 免疫程序 0,14,28

干预措施代码:

Intervention:

High-dose vaccine for subjects aged >55 years (0, 14, 28 day regimen)

Intervention code:

组别:

7

样本量:

8

Group:

7

Sample size:

干预措施:

18-55岁,安慰剂0.5mL 免疫程序 0,28天

干预措施代码:

Intervention:

Placebo(0.5mL)for subjects aged 18-55 years (0, 28 day regimen)

Intervention code:

组别:

8

样本量:

6

Group:

8

Sample size:

干预措施:

大于55岁,安慰剂0.5mL 免疫程序 0,28天

干预措施代码:

Intervention:

Placebo(0.5mL) for subjects aged > 55 years (0, 28 day regimen)

Intervention code:

组别:

9

样本量:

8

Group:

9

Sample size:

干预措施:

18-55岁,安慰剂 1mL 免疫程序 0,14,28天

干预措施代码:

Intervention:

Placebo (1ml) for subjects aged 18-55 years (0, 14, 28 day regimen)

Intervention code:

组别:

10

样本量:

6

Group:

10

Sample size:

干预措施:

大于55岁,安慰剂1mL 免疫程序 0,14,28天

干预措施代码:

Intervention:

Placebo (1ml) for subjects aged > 55 years (0, 14, 28 day regimen)

Intervention code:

组别:

11

样本量:

8

Group:

11

Sample size:

干预措施:

18-55岁,安慰剂 1mL 免疫程序 0,28天

干预措施代码:

Intervention:

Placebo (1ml) for subjects aged 18-55 years (0, 28 day regimen)

Intervention code:

组别:

12

样本量:

6

Group:

12

Sample size:

干预措施:

大于55岁,安慰剂1mL 免疫程序 0,28天

干预措施代码:

Intervention:

Placebo (1ml) for subjects aged > 55 years (0, 28 day regimen)

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

江苏 

市(区县):

南京 

Country:

China 

Province:

Jiangsu 

City:

nanjing 

单位(医院):

江苏省疾病预防控制中心 

单位级别:

省级疾病预防控制中心 

Institution
hospital:

Jiangsu Provincial Center for Diseases Control and Prevention  

Level of the institution:

Provincial Center for Diseases Control and Prevention 

测量指标:

Outcomes:

指标中文名:

各研究组每次免疫后0-7天不良反应(AR)发生率

指标类型:

主要指标 

Outcome:

Occurrence of adverse events (AE) within 7 days after each dose of the recombinant SARS-CoV-2 vaccine (Sf9 cell) or placebo

Type:

Primary indicator 

测量时间点:

每次免疫后0-7天

测量方法:

Measure time point of outcome:

within 7 days after each dose

Measure method:

指标中文名:

各研究组每次免疫后0-7天不良事件(AE)发生率

指标类型:

次要指标 

Outcome:

Occurrence of adverse events (AE) within 7 days after each dose

Type:

Secondary indicator 

测量时间点:

每次免疫后0-7天

测量方法:

Measure time point of outcome:

within 7 days after each dose

Measure method:

指标中文名:

各研究组首次至末次免疫后第28天不良事件(AE)发生率

指标类型:

次要指标 

Outcome:

Occurrence of AE up to Day 28 after prime and boost vaccination.

Type:

Secondary indicator 

测量时间点:

首次至末次免疫后第28天

测量方法:

Measure time point of outcome:

Day 28 after prime and boost vaccination.

Measure method:

指标中文名:

各研究组首次至末次免疫后第28天严重不良事件发生率

指标类型:

次要指标 

Outcome:

The proportion of SAEs up to Day 28 after prime and boost vaccination

Type:

Secondary indicator 

测量时间点:

首次至末次免疫后第28天

测量方法:

Measure time point of outcome:

Day 28 after each dose

Measure method:

指标中文名:

各研究组首次至末次免疫后第12个月严重不良事件发生率

指标类型:

次要指标 

Outcome:

The proportion of SAEs up to Month 12

Type:

Secondary indicator 

测量时间点:

首次至末次免疫后第12个月

测量方法:

Measure time point of outcome:

Month 12 after the first dose

Measure method:

指标中文名:

试者首次免疫前7天内和每次免疫后第3天的实验室检验指标的变化(包括白细胞计数、淋巴细胞计数、中性粒细胞计数、血小板、血红蛋白、谷丙转氨酶ALT、谷草转氨酶AST、总胆红素、空腹血糖、肌酐、凝血酶原时间、部分活化凝血酶原时间、尿蛋白、尿红细胞)。

指标类型:

次要指标 

Outcome:

The proportion of abnormal markers of hematology, blood chemistry and urine analysis within 7 days before prime vaccination and at Day 3 after each dose of recombinant SARS-CoV-2 vaccine (Sf9 cell) or placebo.

Type:

Secondary indicator 

测量时间点:

首次免疫前7天内和每次免疫后3天

测量方法:

Measure time point of outcome:

7 days before prime vaccination and Day 3 after each dose.

Measure method:

指标中文名:

各研究组末次免疫后第7天、14天、28天、第3个月、第6个月、第12个月抗2019新型冠状病毒的S-RBD蛋白特异性抗体(ELISA法)的几何平均滴度(GMT);

指标类型:

次要指标 

Outcome:

GMT of anti-RBD specific antibody at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.

Type:

Secondary indicator 

测量时间点:

末次免疫后第7天、14天、28天、第3个月、第6个月、第12个月

测量方法:

Measure time point of outcome:

Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.

Measure method:

指标中文名:

各研究组末次免疫后第7天、14天、28天、第3个月、第6个月、第12个月抗2019新型冠状病毒的S-RBD蛋白特异性抗体(ELISA法)的阳转率(四倍增长)

指标类型:

次要指标 

Outcome:

Four-fold increase (seroconversion) in anti-RBD specific antibody titers, at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.

Type:

Secondary indicator 

测量时间点:

末次免疫后第7天、14天、28天、第3个月、第6个月、第12个月

测量方法:

Measure time point of outcome:

Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.

Measure method:

指标中文名:

? 各研究组末次免疫后第7天、14天、28天、第3个月、第6个月、第12个月抗2019新型冠状病毒的S-RBD蛋白特异性抗体(ELISA法)的几何平均增长倍数(GMI);

指标类型:

次要指标 

Outcome:

GMFI of anti-RBD specific antibody at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.

Type:

Secondary indicator 

测量时间点:

末次免疫后第7天、14天、28天、第3个月、第6个月、第12个月

测量方法:

Measure time point of outcome:

Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.

Measure method:

指标中文名:

各研究组末次免疫后第7天、14天、28天、第3个月、第6个月、第12个月抗2019新型冠状病毒特异性中和抗体(真病毒和假病毒中和试验法)的几何平均滴度(GMT);

指标类型:

次要指标 

Outcome:

GMT of SARS-CoV-2 neutralizing antibody at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.

Type:

Secondary indicator 

测量时间点:

末次免疫后第7天、14天、28天、第3个月、第6个月、第12个月

测量方法:

Measure time point of outcome:

Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.

Measure method:

指标中文名:

各研究组末次免疫后第7天、14天、28天、第3个月、第6个月、第12个月抗2019新型冠状病毒特异性中和抗体(真病毒和假病毒中和试验法)的阳转率(四倍增长);

指标类型:

次要指标 

Outcome:

Four-fold increase (seroconversion) in SARS-CoV-2 neutralizing antibody titers, at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.

Type:

Secondary indicator 

测量时间点:

末次免疫后第7天、14天、28天、第3个月、第6个月、第12个月

测量方法:

Measure time point of outcome:

Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination

Measure method:

指标中文名:

各研究组末次免疫后第7天、14天、28天、第3个月、第6个月、第12个月抗2019新型冠状病毒特异性中和抗体(真病毒和假病毒中和试验法)的几何平均增长倍数(GMI)

指标类型:

次要指标 

Outcome:

GMFI of SARS-CoV-2 neutralizing antibody at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after prime and boost vaccination.

Type:

Secondary indicator 

测量时间点:

末次免疫后第7天、14天、28天、第3个月、第6个月、第12个月

测量方法:

Measure time point of outcome:

Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination

Measure method:

指标中文名:

各研究组末次免疫后第14天、28天ELISpot检测S-RBD蛋白重叠肽库激发的IFN-γ的阳性率和水平。

指标类型:

次要指标 

Outcome:

Seroconversion rates of IFN-γ stimulated by the overlapping peptide library of S-RBD protein at Day 14, Day 28 after boost vaccination.

Type:

Secondary indicator 

测量时间点:

末次免疫后第14天、28天

测量方法:

Measure time point of outcome:

Day 14, Day 28 after boost vaccination.

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

使用后保存 

说明

Fate of sample:

Preservation after use 

Note:

标本中文名:

咽拭子

组织:

Sample Name:

throat swab

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

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 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):

本研究采用分层区组随机方法。由随机专员采用SAS软件以分层区组随机化方法产生随机编码,每个剂量组内试验苗与安慰剂对照苗按3:1的比例设置。

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

Stratified blocked randomization will be used to divide participants into experimental group and control group, which will be performed by statistic software SAS by a special personnel.

盲法:

本次临床试验实施过程中,应保持双盲状态,即研究者和受试者均不知道受试者接种的是试验疫苗还是安慰剂对照。 首次分析交由独立的统计方完成,统计方独立揭盲进行统计分析,并向申办方和研究者提交首次分析报告,首次分析报告中不得透露受试者个人的分组信息。现场将仍然维持双盲状态,整个临床试验开展期间不得泄露盲底。

Blinding:

Double blind

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):

Not stated

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

Not stated

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:

EDC

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

EDC

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-08-28
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