注册号: Registration number: |
ChiCTR2100053551 |
最近更新日期: Date of Last Refreshed on: |
2022-05-18 16:21:48 |
注册时间: Date of Registration: |
2021-11-24 00:00:00 |
注册号状态: |
预注册 |
Registration Status: |
Prospective registration |
注册题目: |
评价新型冠状病毒mRNA疫苗在18~59岁和60岁及以上已接种新型冠状病毒灭活疫苗人群中加强接种的免疫原性和安全性的IIIb期临床试验 |
Public title: |
Phase IIIb clinical trial to evaluate the immunogenicity and safety of booster vaccination of 2019-nCoV mRNA vaccine in people aged 18-59 years and 60 years and older who have been vaccinated with 2019-nCoV inactivated vaccine |
注册题目简写: |
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English Acronym: |
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研究课题的正式科学名称: |
评价新型冠状病毒mRNA疫苗在18~59岁和60岁及以上已接种新型冠状病毒灭活疫苗人群中加强接种的免疫原性和安全性的IIIb期临床试验 |
Scientific title: |
Phase IIIb clinical trial to evaluate the immunogenicity and safety of booster vaccination of 2019-nCoV mRNA vaccine in people aged 18-59 years and 60 years and older who have been vaccinated with 2019-nCoV inactivated vaccine |
研究课题代号(代码): Study subject ID: |
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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: |
杨舒媛 |
研究负责人: |
袁琳 |
Applicant: |
Yang Shuyuan |
Study leader: |
Yuan Lin |
申请注册联系人电话: Applicant telephone: |
+86 18687832269 | 研究负责人电话: Study leader's |
+86 871 68312889 |
申请注册联系人传真 : Applicant Fax: |
研究负责人传真: Study leader's fax: |
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申请注册联系人电子邮件: Applicant E-mail: |
ynwsysy@walvax.com | 研究负责人电子邮件: Study leader's E-mail: |
ynwsysy@walvax.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): |
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申请注册联系人通讯地址: |
云南省昆明市高新区云南省大学科技园2期A3幢3楼 |
研究负责人通讯地址: |
云南省昆明市高新区云南省大学科技园2期A3幢3楼 |
Applicant address: |
3rd Floor, Building A3, Phase 2, Yunnan University Science and Technology Park, High-tech Zone, Kunming, Yunnan |
Study leader's address: |
3rd Floor, Building A3, Phase 2, Yunnan University Science and Technology Park, High-tech Zone, Kunming, Yunnan |
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: |
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申请人所在单位: |
云南沃森生物技术股份有限公司 |
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Applicant's institution: |
Walvax Biotechnology Co., Ltd. |
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研究负责人所在单位: |
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Affiliation of the Leader: |
是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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伦理委员会批件文号: Approved No. of ethic committee: |
GXIRB2021-0042-1 | 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: |
广西伦理审查委员会 |
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Name of the ethic committee: |
Guangxi Institutional Review Board |
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伦理委员会批准日期: Date of approved by ethic committee: |
2021-10-24 00:00:00 | ||
伦理委员会联系人: |
韩彦彬 |
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Contact Name of the ethic committee: |
Han Yanbin |
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伦理委员会联系地址: |
广西南宁市金洲路18号 |
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Contact Address of the ethic committee: |
18 Jinzhou Road, Nanning, Guangxi Zhuang Autonomous Region |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
+86 771 2518136 | 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: |
云南沃森生物技术股份有限公司 |
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Primary sponsor: |
Walvax Biotechnology Co., Ltd. |
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研究实施负责(组长)单位地址: |
云南省昆明市高新区云南省大学科技园二期A3栋3楼 |
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Primary sponsor's address: |
3rd Floor, Building A3, Phase 2, Yunnan University Science and Technology Park, High-tech Zone, Kunming, Yunnan |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
自筹 |
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Source(s) of funding: |
Self-funded |
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研究疾病: |
新型冠状病毒肺炎(COVID-19) |
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Target disease: |
Novel Coronavirus Pneumonia (COVID-19) |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
干预性研究 |
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Study type: |
Interventional study |
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研究所处阶段: |
III期临床试验 | ||||||||||||||||||||||||||||||||||||||||||||
Study phase: |
3 |
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研究设计: |
随机平行对照 |
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Study design: |
Parallel |
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研究目的: |
1.评估18-59岁和60岁及以上已接种两剂新型冠状病毒灭活疫苗人群加强接种1剂试验疫苗或对照疫苗针对原型株的免疫原性; 2.评估18-59岁和60岁及以上已接种两剂新型冠状病毒灭活疫苗人群加强接种1剂试验疫苗或对照疫苗的安全性。 |
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Objectives of Study: |
1. Assess the immunogenicity of 1 dose of test vaccine or control vaccine against the prototype strain in people aged 18-59 and 60 years and above who have been vaccinated with two doses of new coronavirus inactivated vaccine; 2. Evaluate the safety of boosting 1 dose of experimental vaccine or control vaccine for people aged 18-59 and 60 years and above who have been vaccinated with two doses of novel coronavirus inactivated vaccine. |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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纳入标准: |
1.能提供法定身份证明的18~59岁或60岁及以上受试者,男女兼有; |
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Inclusion criteria |
1. Subjects aged 18-59 years or aged 60 and above who can provide legal identification, no gender limit; |
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排除标准: |
1.COVID-19病史或使用过除2剂科兴新型冠状病毒灭活疫苗以外的任何COVID-19预防性药物(例如,已上市或未上市的任何其他非科兴新型冠状病毒灭活疫苗接种史,或2剂以上科兴新型冠状病毒灭活疫苗接种史); |
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Exclusion criteria: |
1. History of COVID-19 or use of any COVID-19 preventive medicine except 2 doses of Kexings novel coronavirus inactivated vaccine (For example, the vaccination history of any other non-Kexing 2019-nCoV inactivated vaccine that has been listed or not listed, or the vaccination history of more than 2 doses of Kexing 2019-nCoV inactivated vaccine); |
研究实施时间: Study execute time: |
从 From 2021-11-25 00:00:00至 To 2023-01-31 00:00:00 | 征募观察对象时间: Recruiting time: |
从 From 2021-11-25 00:00:00 至 To 2021-12-31 00:00:00 |
干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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采集人体标本: Collecting sample(s) |
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征募研究对象情况: Recruiting status: |
正在进行 Recruiting |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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随机方法(请说明由何人用什么方法产生随机序列): |
随机化统计师应用SAS统计软件(9.4版本以上版本),采用区组随机方式产生随机化盲底。 |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
The randomization codes will be generated by the randomization statistician using the block randomization method through SAS statistical software (version 9.4 or higher). |
是否公开试验完成后的统计结果: Calculated Results after the Study Completed public access: |
不公开/Private |
盲法: |
未说明 |
Blinding: |
Not stated |
是否共享原始数据: IPD sharing |
否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): |
手动上传 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): |
Upload manually |
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: |
使用电子数据采集(EDC)系统对用于统计分析的必要数据进行采集。 |
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
Electronic data capture (EDC) system will be used to collect necessary data for statistical analysis. |
数据与安全监察委员会: Data and Safety Monitoring Committee: |
有/Yes |