江苏省疾病预防控制中心 江苏省公共卫生研究院
  • IPV6

2020-09-30

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Project Title: Clinical Study of Phase I/II of SARS-CoV-2 Vaccine (Vero cell), Inactivated

项目名称:灭活新型冠状病毒疫苗1期/2期临床试验

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Data Sharing Statement

  We support data sharing of the individual participant data. The individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendixes) will be shared. Since this clinical trial is ongoing, and all the individual participant data cannot be available until the immune persistence evaluation are conducted. In order to maintain the blind status of this trial, only the statisticians, an independent third party of this trial, are unblinded. The data will be available immediately following publication and clinical study report (CSR) finalization for at least 6 months.Supporting clinical documents including study protocol, statistical analysis plan (SAP), and the informed consent form (ICF) will be available immediately following publication for at least one year. Supporting clinical documents access information will be available at the following link. Researchers who provide a scientifically sound proposal will be allowed to access to the individual participant data. Proposals should be directed to jszfc@vip.sina.com or gaoq@sinovac.com. These proposals will be reviewed and approved by the sponsor, investigator and collaborators on the basis of scientific merit. To gain access, data requestors will need to sign a data access agreement.

 

 

下载链接 download: 

Clinical Protocol-THELANCETID-D-20-05605.pdf
SAP for sharing V1.0(EN).pdf
Informed Consent to Participate in the Phase I&II Clinical Trial of SARS-CoV-2 Vaccine (Vero Cell), Inactivated.pdf
江苏省疾病预防控制中心 江苏省公共卫生研究院