揭底:国药灭活疫苗三期临试的年龄范围

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楼主 (文学城)

国药集团,英文缩写为Sinopharm,全称China National Pharmaceutical Group Co., Ltd.

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

“国药集团疫苗已经在阿联酋、巴林、埃及、约旦、秘鲁、阿根廷等10个国家开展国际临床三期实验”

每个国家要分别开设三期临试。

 

其灭活疫苗在南美(阿根廷)三期临试的公示网址

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

捡重点摘要如下:

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: Laboratorio Elea Phoenix S.A.  Collaborators: Beijing Institute of Biological Products Co., Ltd China National Biotec Group Company Limited Fundación Huésped  

检测的内容是

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

受试人选择标准

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.

 

另一个在中东(阿联酋)的三期,初期参试者不过60岁

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.