揭底：國藥滅活疫苗三期臨試的年齡範圍

來源: 於 2021-02-02 16:09:18 [博客] [舊帖] [給我悄悄話] 本文已被閱讀：次

國藥集團，英文縮寫為Sinopharm，全稱China National Pharmaceutical Group Co., Ltd.

https://www.bbc.com/zhongwen/simp/science-55484664

“國藥集團疫苗已經在阿聯酋、巴林、埃及、約旦、秘魯、阿根廷等10個國家開展國際臨床三期實驗”

每個國家要分別開設三期臨試。

 

其滅活疫苗在南美（阿根廷）三期臨試的公示網址

https://clinicaltrials.gov/ct2/show/NCT04560881

撿重點摘要如下：

Brief Summary:
This is a randomized, double blind, placebo parallel-controlled phase III clinical trial to evaluate the efficacy, immunogenicity and safety of the inactivated SARS-CoV-2 Vaccine (Vero cell) in Argentine healthy population aged between 18 and 85 years old.
 
Sponsor:
Collaborators:
Beijing Institute of Biological Products Co., Ltd
China National Biotec Group Company Limited
Fundación Huésped
 

檢測的內容是

Biological: Inactivated SARS-CoV-2 vaccine (Vero cell)Biological: Placebo/Aluminum Adjuvant of Inactivated SARS-CoV-2 vaccine

受試人選擇標準

Ages Eligible for Study:    18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:    All
Accepts Healthy Volunteers:    Yes
Criteria

Inclusion Criteria:

  • Healthy subjects aged between 18 and 85 years old.
  • By asking for medical history and physical examination, the investigator judged that the health condition is well.
  • Female subjects of childbearing age are not nursing or pregnant at the time of enrolment (negative urine pregnancy test) and have no family planning within the first 3 months after enrolment. Effective contraceptive measures have been taken within 2 weeks before inclusion.
  • During the whole follow-up period of the study, be able and willing to complete the whole prescribed study plan.
  • With self-ability to understand the study procedures, the informed consent & voluntarily sign an informed consent form and be able to comply with the requirements of the protocol.

 

另一個在中東（阿聯酋）的三期，初期參試者不過60歲

https://www.clinicaltrialsarena.com/news/sinopharm-covid-vaccine-uae-trial/

The UAE has authorised the participation of up to 15,000 volunteers in the trials. G42 and SEHA intend to enrol at least 5,000 volunteers aged 18 to 60 years in the first stage.