Re: [新聞] 智飛疫苗完成三期 打3劑保護力逾8成

很好奇地去查了一些相關資料
Clinical Trial
https://clinicaltrials.gov/ct2/show/record/NCT04646590

重點 Phase 3
1. Case Number
A randomized, double-blind, placebo-controlled international multicenter
clinical trial design will be adopted. A total of 29,000 subjects aged 18
years and above are planned to be recruited, including 750 subjects aged
18-59 years and 250 subjects aged 60 years and above in China; 21,000
subjects aged 18-59 years and 7,000 subjects aged 60 years and above will be
recruited outside China. Safety and immunogenicity will be evaluated among
the Chinese subjects, and efficacy, immunogenicity and safety will be
evaluated among the subjects outside China. Among them, 750 subjects aged
18-59 and 250 subjects aged 60 and above from outside China and all subjects
from China will be selected as the immunogenicity subgroup for immunogenicitybridging study. The IgG levels of SARS-COV-2 neutralizing antibody and RBD
protein binding antibody will be detected by blood sampling before
vaccination, 14 days and 6 months after full course of vaccination to
evaluate the immunogenicity and immune persistence.

2. Outcome
The endpoint of efficacy study [ Time Frame: Up to one year after the
vaccination ]
The number of severe and severity above COVID-19 cases 14 days after whole
vaccination; The number of any severity of COVID-9 cases after first dose of
vaccination; The number of COVID-19 cases of any severity in populations of
different age group (18-59 years vs. 60 years and above) 14 days after whole
vaccination.
Endpoint of immunogenicity and immune persistence study [ Time Frame: At 14
days and 6 months after full course of vaccination ]
The level of neutralizing antibody to SARS-COV-2 and IgG level of RBD proteinbinding antibody at 14 days and 6 months after full course of vaccination.

目前結果還沒上傳

過去1.2 期的相關資料
https://reurl.cc/9rMWad

根據科學的精神，大家可以對研究過程和結果提出質疑
但智飛確實在作三期實驗
我們的高端????

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※ 發信站: 批踢踢實業坊(ptt.cc), 來自: 61.227.55.140 (臺灣)

IRB呢? 受試者同意書呢? 有保險嗎? 有把計畫登錄在 clinicaltrial嗎? 這也配叫試驗? 醫學倫理都沒有了 國外會承認嗎?

※ 編輯: monyan (61.227.55.140 臺灣), 08/29/2021 11:40:23