江苏省疾病预防控制中心(江苏省预防医学科学院)
  • IPV6

2020-05-17

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First-in Human Trial with A Recombinant Adenovirus Type 5 Vectored COVID-19 Vaccine (腺病毒5型载体新冠疫苗1期临床研究)

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  Safety, tolerability and immunogenicity of a recombinant adenovirus type 5 vectored COVID-19 vaccine in healthy adults in China: preliminary report of a first-in human single-center, open-label, non-randomised, dose-escalating clinical trial

  Date Sharing Statement

  We support data sharing of the individual participant data. The individual participant data that underlie the results reported in this article, after deidenti?cation (text, tables, figures, and appendixes) will be shared. Individual participant data will be available beginning 3 months and ending one year following article publication. 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 links. 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 cw0226@foxmail.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:

Informed consent form.pdf
Statistical analysis plan.pdf
Protocol of the recombinant adenovirus type 5 vectored COVID-19 vaccine in healthy adults in China (Version 1.4) .pdf
江苏省疾病预防控制中心(江苏省预防医学科学院)