Today is 2021-11-30

A Phase III Clinical Trial of Influenza Virus Vector COVID- 19 Vaccine for Intranasal Spray (DelNS1-2019-nCoV-RBD-OPT1)
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注册号:

Registration number:

ChiCTR2100051391 

最近更新日期:

Date of Last Refreshed on:

2021-11-30 

注册时间:

Date of Registration:

2021-09-22 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

鼻喷流感病毒载体新冠肺炎疫苗( DelNS1-2019-nCoV-RBD-OPT1)Ⅲ期临床试验 

Public title:

A Phase III Clinical Trial of Influenza Virus Vector COVID- 19 Vaccine for Intranasal Spray (DelNS1-2019-nCoV-RBD-OPT1) 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

评价鼻喷流感病毒载体新冠肺炎疫苗(DelNS1-2019-nCoV-RBD-OPT1)在 18 岁及以上成人受试者中的保护效力、安全性的国际多 中心、随机、双盲、安慰剂对照的Ⅲ期临床试验 

Scientific title:

A Global, Multi-center, Randomized, Double-blind, Placebocontrolled Phase III Clinical Trial to Evaluate the Protective Efficacy and Safety of Influenza Virus Vector COVID-19 Vaccine for Intranasal Spray (DelNS1-2019-nCoV-RBD-OPT1) in Adults Aged 18 Years and Older 

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:

叶祥忠 

研究负责人:

朱凤才 

Applicant:

Xiangzhong Ye 

Study leader:

Fengcai Zhu 

申请注册联系人电话:

Applicant telephone:

+86 10 59528966 5089  

研究负责人电话:

Study leader's telephone:

+86 25 83759418 

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:

yexiangzhong@ystwt.com 

研究负责人电子邮件:

Study leader's E-mail:

jszfc@vip.sina.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:

北京市昌平区科学园路31号 

研究负责人通讯地址:

江苏省南京市鼓楼区江苏路172号 

Applicant address:

31 Kexueyuan Road, Changping District, Beijing, China 

Study leader's address:

172 Jiangsu Road, Gulou District, 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:

北京万泰生物药业股份有限公司 

Applicant's institution:

Beijing Wantai Biological Pharmacy Enterprise 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:

SJREB-2021-76 

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:

Signal Joint Research Ethics Board 

Name of the ethic committee:

Signal Joint Research Ethics Board 

伦理委员会批准日期:

Date of approved by ethic committee:

2021-09-14 

伦理委员会联系人:

Jamie 

Contact Name of the ethic committee:

Jamie 

伦理委员会联系地址:

菲律宾共和国,马尼拉科鲁兹市里扎尔大道圣拉扎罗大院 3 号楼 

Contact Address of the ethic committee:

Republic of the Philippines,Bldg. 3, San Lazaro Compound, Rizal Avenue, Sta. Cruz, Manila 

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:

N/A 

Primary sponsor:

N/A 

研究实施负责(组长)单位地址:

N/A 

Primary sponsor's address:

N/A 

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):

Country:

Ching

Province:

Beijing

City:

单位(医院):

北京万泰生物药业股份有限公司

具体地址:

昌平区科学园路31号

Institution
hospital:

Beijing Wantai Biological Pharmacy Enterprise Co.,Ltd.

Address:

31 Kexueyuan Road, Changping District

经费或物资来源:

完全自筹 

Source(s) of funding:

Self financing 

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:

III期临床试验 

Study phase:

研究目的:

主要目的: 1.评价DelNS1-2019-nCoV-RBD-OPT1预防病毒学确诊(RT-PCR阳性)的症状性COVID-19的保护效力。 2.评价DelNS1-2019-nCoV-RBD-OPT1的安全性。 次要目的: 1.评价DelNS1-2019-nCoV-RBD-OPT1预防重型COVID-19的保护效力。 2.评价不同年龄组中DelNS1-2019-nCoV-RBD-OPT1预防任何严重程度的症状性COVID-19的保护效力。 3.评价DelNS1-2019-nCoV-RBD-OPT1预防病毒学确诊(RT-PCR阳性)的COVID-19死亡的保护效力。 4.评价慢性疾病患者中DelNS1-2019-nCoV-RBD-OPT1预防任何严重程度的症状性COVID-19的保护效力。 5.评价既往接种过新型冠状病毒疫苗受试者中DelNS1-2019-nCoV-RBD-OPT1预防病毒学确诊(RT-PCR阳性)的症状性COVID-19的保护效力 

Objectives of Study:

Primary objective: 1.To evaluate the protective efficacy of DelNS1-2019-nCoV-RBD-OPT1 for preventing virologically confirmed (RT-PCR-positive) symptomatic COVID-19. 2.To evaluate the safety of DelNS1-2019-nCoV-RBD-OPT1. Secondary objectives: 1. To evaluate the protective efficacy of DelNS1-2019-nCoV-RBD-OPT1 against severe COVID-19. 2. To evaluate the protective efficacy of DelNS1-2019-nCoV-RBD-OPT1 against symptomatic COVID-19 of any severity in different age groups. 3. To evaluate the protective efficacy of DelNS1-2019-nCoV-RBD-OPT1 against virologically -confirmed (RT-PCR-positive) COVID-19 deaths. 4. To evaluate the protective efficacy of DelNS1-2019-nCoV-RBD-OPT1 against symptomatic COVID-19 of any severity in patients with chronic diseases. 5. To evaluate the protective efficacy of DelNS1-2019-nCoV-RBD-OPT1 against virologically confirmed (RT-PCR positive) symptomatic COVID-19 in subjects previously administered with COVID-19 vaccine. 

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.入组时年龄满18周岁; 2.能遵守临床研究方案的要求完成所有试验程序,并且签署知情同意书; 3.未接种过任何新型冠状病毒疫苗(已上市的或在研的),或者已接种其他的新型冠状病毒疫苗(已上市的或在研的)至少1剂,且最后1剂接种时间距离本研究受试者签署知情同意日期≥6个月; 4.艾滋病病毒(HIV)筛查阴性者(按照试验所在国的相关政策进行,如有的国家HIV检测需要有资质,则以问询为主,同时需要注意保护受试者隐私); 5.具有生育能力的男性和育龄期女性自愿从签署知情书开始至末次疫苗接种完成后3个月使用适当的避孕措施,包括禁欲或有效的避孕措施(如宫内或植入式避孕装置,口服避孕药,子宫隔膜或避孕套与避孕凝胶结合使用);育龄期女性在接种日的妊娠试验结果呈阴性; 6.健康受试者或存在轻度基础疾病的受试者[入选本研究前至少3个月处于病情未加重(无须入院治疗或治疗方案无重大调整等)的稳定状态]。 

Inclusion criteria

1. Aged >= 18 years old at the time of enrollment; 2. Be able to comply with the requirements of clinical study protocol and complete all trial procedures, and sign informed consent form; 3. Subjects who have not received any COVID-19 vaccine (marketed or investigational), those who have received at least one dose of other COVID-19 vaccines (marketed or investigational) with an interval of ≥ 6 months between the last dose and the date when the subjects sign the informed consent for this study; 4. Those who are negative for HIV screening (depending on the relevant policy of the country where the trial is conduct, if qualification for HIV testing is required in the country, this information will be obtained mainly by inquiry while protecting the candidates privacy); 5. Fertile males and females of childbearing potential who are willing to take appropriate contraceptive measures from signing ICF to 3 months after the last dose, including abstinence or effective contraceptive measures (e.g., intrauterine or implantable contraceptive devices, oral contraception, combination of contraceptive diaphragm or condom with contraceptive gel); women of childbearing potential should be negative for pregnancy test on the day of vaccination. 6. Healthy people or people with a mild underlying disease that has remained stable without exacerbation (not requiring hospitalization or without major modification of the treatment regimen) within at least 3 months prior to inclusion in the study. 

排除标准:

1.既往COVID-19感染病史; 2.筛选时SARS-CoV-2特异性总抗体胶体金试剂检测结果阳性的受试者[仅适用于无新型冠状病毒疫苗(已上市的或在研的)接种史的受试者]; 3.妊娠或哺乳期女性; 4.接种疫苗当天或前3天内发热(口温≥37.5℃/腋温≥37.3℃); 5.过去5天内曾患有任何急性疾病且需要全身应用抗生素或抗病毒[包括但不限于使用奥司他韦(Tamiflu),扎那米韦(Relenza),金刚烷胺(Symmetrel)或金刚乙胺(Flumadine)等抗流感病毒药物]治疗者; 6.患有免疫缺陷疾病、重要脏器疾病、癌症、免疫性疾病(包括格林巴利综合症、系统性红斑狼疮、类风湿关节炎、任何情况导致的无脾或脾切除以及其他研究者认为可能对免疫应答反应有影响的免疫性疾病)等导致免疫功能低下者; 7.首剂疫苗接种前6个月内长期服用(定义为14天以上)免疫抑制剂或其他免疫调节药物(对于皮质类固醇,如≥10 mg/天强的松或相当剂量;允许使用吸入和局部类固醇); 8.有出血性疾病史(如因子缺乏症、血小板减少症等凝血功能障碍性疾病),或有出血倾向者,或需要持续使用抗凝药; 9.接种研究疫苗前3个月内注射过免疫球蛋白和/或任何血液制品; 10.接种疫苗前14天内接受过亚单位或灭活疫苗,或前28天内接受过减毒活疫苗; 11.接种疫苗前1个月内接受过其他药物临床试验,或计划在研究期间参加其他药物临床试验; 12.严重过敏反应史或既往免疫接种有严重不良反应,或对研究疫苗的任何成分过敏; 13.研究者认为不适合鼻喷给药的患者(如有严重鼻炎、鼻腔畸形等); 14.计划研究结束前从本地区永久搬迁或在研究访视期间长期(影响预定的访视时间)离开本地; 15.研究者认为不适宜参加试验的其他情况。 

Exclusion criteria:

1. Prior history of COVID-19; 2. Positive test of total SARS-CoV-2 specific antibody using colloidal gold reagent [Only applicable to subjects without vaccination history of COVID-19 vaccine (marketed or investigational)]; 3. Pregnant or lactating women; 4. Fever on the day of vaccination or within 3 days prior to vaccination (oral temperature >= 37.5 degree C/axillary temperature >= 37.3 degree C); 5. Those who had any acute disease in the past 5 days that requires systemic antibiotic or antiviral treatment (including but not limited to the use of anti-influenza virus drugs such as Tamiflu, Relenza, Symmetrel or Flumadine); 6. Those who had low immune function caused by immunodeficiency diseases, diseases of important organs, cancer, and immune diseases (e.g. Guillain Barre syndrome, systemic lupus erythematosus, rheumatoid arthritis, alienia or splenectomy caused by any condition, and other immune disease that may affect immune response at the investigators discretion); 7. Long-term use (defined as >= 14 days) of immunosuppressants or other immunomodulators (for glucocorticoids, e.g., >= 10 mg/day prednisone or equivalent dose; inhaled and topical steroids are allowed) within 6 months prior to the first vaccination; 8. History of hemorrhagic diseases (e.g., factor deficiency, thrombocytopenia or other coagulation disorders), or hemorrhagic tendency, or continuous requirement of anticoagulants; 9. Having received immunoglobulins and/or blood products within 3 months before receiving the investigational vaccine; 10. Received subunit or inactivated vaccine within 14 days before vaccination, or received live attenuated vaccine within 28 days before vaccination; 11. Participation in a clinical trial of another product within 1 month prior to vaccination, or planning to participate in a clinical trial of another product during the study; 12. Having a history of severe allergic reactions or severe adverse reactions from previous immunizations, or allergy to any component of the investigational vaccine; 13. Patients deemed by the investigator as unsuitable for using nasal spray (those with severe rhinitis or nasal deformities, etc.); 14. Planning to relocate permanently from the current area prior to the completion of the study or to leave the current area for a long period (preventing compliance with the prescribed visit schedule) during the study visits; 15)Other conditions that the investigators consider unsuitable for this clinical study. 

研究实施时间:

Study execute time:

From2021-10-28To 2023-02-28 

征募观察对象时间:

Recruiting time:

From2021-10-28To 2022-04-28 

干预措施:

Interventions:

组别:

试验组

样本量:

20000

Group:

Experimental group

Sample size:

干预措施:

0、14天接种试验疫苗

干预措施代码:

Intervention:

Inoculate the test vaccine on day 0 and 14

Intervention code:

组别:

对照组

样本量:

20000

Group:

Control group

Sample size:

干预措施:

0、14天接种安慰剂对照疫苗

干预措施代码:

Intervention:

Placebo control vaccine was administered on day 0 and 14

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

菲律宾 

省(直辖市):

奎松 

市(区县):

 

Country:

Philippines 

Province:

Quezon 

City:

 

单位(医院):

Quirino Memorial Medical Center 

单位级别:

 

Institution
hospital:

Quirino Memorial Medical Center  

Level of the institution:

 

国家:

菲律宾 

省(直辖市):

伊洛伊洛 

市(区县):

 

Country:

Philippines 

Province:

Iloilo 

City:

 

单位(医院):

The Medical City Iloilo (TMC) 

单位级别:

 

Institution
hospital:

The Medical City Iloilo (TMC)  

Level of the institution:

 

国家:

菲律宾 

省(直辖市):

甲米地 

市(区县):

 

Country:

Philippines 

Province:

Cavite 

City:

 

单位(医院):

Silang Specialist Medical Center 

单位级别:

 

Institution
hospital:

Silang Specialist Medical Center  

Level of the institution:

 

国家:

菲律宾 

省(直辖市):

伊洛伊洛 

市(区县):

 

Country:

Philippines 

Province:

Iloilo 

City:

 

单位(医院):

St. Paul's Hospital Iloilo 

单位级别:

 

Institution
hospital:

St. Paul's Hospital Iloilo  

Level of the institution:

 

国家:

菲律宾 

省(直辖市):

首都区 

市(区县):

 

Country:

Philippines 

Province:

National Capital Region 

City:

 

单位(医院):

Mary Johnston Hospital 

单位级别:

 

Institution
hospital:

Mary Johnston Hospital  

Level of the institution:

 

国家:

菲律宾 

省(直辖市):

卡皮兹 

市(区县):

 

Country:

Philippines 

Province:

Capiz 

City:

 

单位(医院):

The Health Centrum Hospital (THC) 

单位级别:

 

Institution
hospital:

The Health Centrum Hospital (THC)  

Level of the institution:

 

国家:

菲律宾 

省(直辖市):

奎松 

市(区县):

 

Country:

Philippines 

Province:

Quezon 

City:

 

单位(医院):

St. Luke's Medical Center, Global City(SLMC-GC) 

单位级别:

 

Institution
hospital:

St. Luke's Medical Center, Global City(SLMC-GC)  

Level of the institution:

 

国家:

菲律宾 

省(直辖市):

新怡诗夏 

市(区县):

 

Country:

Philippines 

Province:

Nueva Ecija 

City:

 

单位(医院):

Premier Medical Center_PMC 

单位级别:

 

Institution
hospital:

Premier Medical Center_PMC  

Level of the institution:

 

国家:

菲律宾 

省(直辖市):

甲米地 

市(区县):

 

Country:

Philippines 

Province:

Cavite 

City:

 

单位(医院):

Our Lady of The Pillar Medical Center 

单位级别:

 

Institution
hospital:

Our Lady of The Pillar Medical Center  

Level of the institution:

 

国家:

菲律宾 

省(直辖市):

布拉干 

市(区县):

 

Country:

Philippines 

Province:

Bulacan 

City:

 

单位(医院):

Tropical Disease Foundation (TDF) 

单位级别:

 

Institution
hospital:

Tropical Disease Foundation (TDF)  

Level of the institution:

 

国家:

菲律宾 

省(直辖市):

首都区 

市(区县):

 

Country:

Philippines 

Province:

National Capital Region 

City:

 

单位(医院):

Philippine General Hospital 

单位级别:

 

Institution
hospital:

Philippine General Hospital  

Level of the institution:

 

国家:

菲律宾 

省(直辖市):

安赫莱斯市 

市(区县):

 

Country:

Philippines 

Province:

Angeles City 

City:

 

单位(医院):

Angeles University Foundation and Medical Center (AUF) 

单位级别:

 

Institution
hospital:

Angeles University Foundation and Medical Center (AUF)  

Level of the institution:

 

国家:

菲律宾 

省(直辖市):

达沃 

市(区县):

 

Country:

Philippines 

Province:

Davao 

City:

 

单位(医院):

Davao Medical Schools Foundation (DMSF) 

单位级别:

 

Institution
hospital:

Davao Medical Schools Foundation (DMSF)  

Level of the institution:

 

国家:

菲律宾 

省(直辖市):

奎松 

市(区县):

 

Country:

Philippines 

Province:

Quezon 

City:

 

单位(医院):

UERM Memorial Medical Center 

单位级别:

 

Institution
hospital:

UERM Memorial Medical Center  

Level of the institution:

 

国家:

南非 

省(直辖市):

豪登 

市(区县):

 

Country:

South Africa 

Province:

Gauteng 

City:

 

单位(医院):

EMMED Research 

单位级别:

 

Institution
hospital:

EMMED Research  

Level of the institution:

 

国家:

南非 

省(直辖市):

夸祖鲁-纳塔尔 

市(区县):

 

Country:

South Africa 

Province:

KwaZulu-Natal 

City:

 

单位(医院):

Umzimkhulu Research Centre 

单位级别:

 

Institution
hospital:

Umzimkhulu Research Centre  

Level of the institution:

 

国家:

南非 

省(直辖市):

豪登 

市(区县):

 

Country:

South Africa 

Province:

Gauteng 

City:

 

单位(医院):

Progress Clinical Research Unit 

单位级别:

 

Institution
hospital:

Progress Clinical Research Unit  

Level of the institution:

 

国家:

南非 

省(直辖市):

自由省 

市(区县):

 

Country:

South Africa 

Province:

Free State 

City:

 

单位(医院):

JOSHA Research 

单位级别:

 

Institution
hospital:

JOSHA Research  

Level of the institution:

 

国家:

南非 

省(直辖市):

豪登 

市(区县):

 

Country:

South Africa 

Province:

Gauteng 

City:

 

单位(医院):

Aurum Tembisa 

单位级别:

 

Institution
hospital:

Aurum Tembisa  

Level of the institution:

 

国家:

南非 

省(直辖市):

豪登 

市(区县):

 

Country:

South Africa 

Province:

Gauteng 

City:

 

单位(医院):

REIMED REIGER PARK 

单位级别:

 

Institution
hospital:

REIMED REIGER PARK  

Level of the institution:

 

国家:

南非 

省(直辖市):

自由省 

市(区县):

 

Country:

South Africa 

Province:

Free State 

City:

 

单位(医院):

REIMED WELKOM 

单位级别:

 

Institution
hospital:

REIMED WELKOM  

Level of the institution:

 

测量指标:

Outcomes:

指标中文名:

第二剂疫苗接种至少7天后(≥8天)首次发生经病毒学确诊(RT-PCR阳性)的任何严重程度的症状性COVID-19病例

指标类型:

主要指标 

Outcome:

Virologically confirmed (RT-PCR-positive) symptomatic COVID-19 cases of any severity that occurs for the first time at least 7 days (≥ 8 days) after the second vaccination.

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

所有受试者第一剂接种至第二剂接种后12个月内所有严重不良事件(SAE)、其他需要医疗护理的不良事件(MAAE)或特别关注不良事件(AESI)

指标类型:

主要指标 

Outcome:

All serious adverse events (SAEs), other medically attended AEs (MAAEs), and adverse events of special interest (AESIs) from the first dose to 12 months after the second dose in all subjects

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

所有受试者第一剂接种、第二剂接种后7天内发生的所有征集性不良事件

指标类型:

主要指标 

Outcome:

All solicited adverse events within 7 days following the first and second vaccinations in all subjects

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

所有受试者接种间隔期间和第二剂接种后30天内发生的所有非征集性不良事件

指标类型:

主要指标 

Outcome:

All unsolicited adverse events that occur during the interval between doses and within 30 days after the second vaccination in all subjects

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

第二剂疫苗接种至少7天后(≥8天)首次发生经病毒学确诊(RT-PCR阳性)的重型及以上COVID-19病例

指标类型:

次要指标 

Outcome:

Virologically confirmed (RT-PCR-positive) severe and above COVID-19 cases that occurs for the first time at least 7 days (>= 8 days) after the second vaccination

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

18~59岁和≥60岁年龄组受试者中,第二剂疫苗接种至少7天后(≥8天)首次发生经病毒学确诊(RT-PCR阳性)的任何严重程度的症状性COVID-19病例

指标类型:

次要指标 

Outcome:

Virologically confirmed (RT-PCR-positive) symptomatic COVID-19 cases of any severity that occur for the first time at least 7 days after the second vaccination (>= 8 days) in subjects aged 18-59 and >=60 years

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

第二剂疫苗接种至少7天后(≥8天)发生经病毒学确诊(RT-PCR阳性)的COVID-19导致的死亡病例

指标类型:

次要指标 

Outcome:

Virologically confirmed (RT-PCR-positive) death cases resulting from COVID-19 that occur at least 7 days after the second vaccination (>= 8 days)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

明确患有慢性疾病受试者中,第二剂疫苗接种至少7天后(≥8天)首次发生经病毒学确诊(RT-PCR阳性)的任何严重程度的症状性COVID-19病例

指标类型:

次要指标 

Outcome:

Virologically confirmed (RT-PCR-positive) symptomatic COVID-19 cases of any severity that occur for the first time at least 7 days after the second vaccination (>= 8 days) in subjects with a clear chronic disease

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

既往接种过新型冠状病毒疫苗受试者中,首剂疫苗接种至少14天后(≥15天)首次发生经病毒学确诊(RT-PCR阳性)的任何严重程度的症状性COVID-19病例

指标类型:

次要指标 

Outcome:

Virologically confirmed (positive RT-PCR) symptomatic COVID-19 cases of any severity that occurs for the first time at least 14 days (>= 15 days) after the first vaccination in subjects previously administered with COVID-19 vaccine

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

首剂接种疫苗至少14天后(≥15天)首次发生经病毒学确诊(RT-PCR阳性)的任何严重程度的症状性COVID-19病例

指标类型:

附加指标 

Outcome:

Virologically confirmed (RT-PCR-positive) symptomatic COVID-19 cases of any severity that occur for the first time at least 14 days after the first vaccination (>=15 days)

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

第二剂疫苗接种至少7天后(≥8天)首次发生经病毒学确诊(RT-PCR阳性)的不同严重程度的症状性COVID-19病例

指标类型:

附加指标 

Outcome:

Virologically confirmed (RT-PCR-positive) symptomatic COVID-19 cases of different severities that occur for the first time at least 7 days after the second vaccination (>= 8 days)

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

首剂疫苗接种后经病毒学确诊(RT-PCR阳性)的任何严重程度的症状性COVID-19病例,包括非终点病例观察期内(接种间隔期或第2剂接种后7天内)发生的症状性COVID-19的病例

指标类型:

附加指标 

Outcome:

Virologically confirmed (RT-PCR-positive) symptomatic COVID-19 cases of any severity after the first vaccination, including subjects with symptomatic COVID-19 that occur during the observation period of non-endpoint cases (interval between doses or within 7 days after the second vaccination)

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

对于不同国家,第二剂疫苗接种至少7天后(≥8天)首次发生经病毒学确诊(RT-PCR阳性)的任何严重程度的症状性COVID-19病例

指标类型:

附加指标 

Outcome:

Virologically confirmed (RT-PCR-positive) symptomatic COVID-19 cases of any severity that occurs for the first time at least 7 days after the second vaccination (>= 8 days) in different clinical study sites (countries)

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

第二剂疫苗接种至少7天后(≥8天)经病毒学确诊(RT-PCR阳性)的由受关注的突变株(VOC)导致的任何严重程度的症状性COVID-19病例

指标类型:

附加指标 

Outcome:

Virologically confirmed (RT-PCR-positive) symptomatic COVID-19 cases of any severity caused by the variant of concern (VOC) at least 7 days after the second vaccination (>= 8 days)

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

第二剂疫苗接种至少7天后(≥8天)首次发生经病毒学确诊(RT-PCR阳性)的任何严重程度的甲型流感病例

指标类型:

附加指标 

Outcome:

Virologically confirmed (RT-PCR-positive) influenza A cases of any severity that occur for the first time at least 7 days (>= 8 days) after the second vaccination

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

经病毒学确诊(RT-PCR阳性)的症状性COVID-19病例在整个研究期间发生的疫苗增强疾病(VED)事件

指标类型:

附加指标 

Outcome:

Vaccine-enhanced disease (VED) events experienced by subjects with virologically confirmed (RT-PCR-positive) symptomatic COVID-19 throughout the study period

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

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

其它 

说明

Fate of sample:

Others 

Note:

标本中文名:

鼻咽拭子

组织:

Sample Name:

Nasopharyngeal swab

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

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 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SAS 9.4软件,按照分层区组随机方法进行随机

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

SAS 9.4 software is used to carry out randomization according to the stratified block randomization method.

盲法:

双盲

Blinding:

Double blind

是否共享原始数据:

IPD sharing

No

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):

未说明 请阅读网页注册指南中关于“原始数据共享”的内容。

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:

eCRF,EDC系统

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

eCRF,EDC system

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2021-09-22
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