揭底:国药灭活疫苗三期临试的年龄范围

本帖于 2021-02-02 16:38:10 时间, 由普通用户 fuz 编辑

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:
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.

 

 

 

 

所有跟帖: 

欸,发了这么久,咋没人来呛呛。八掛闲扯都那么来劲,看到真凭实据就都沉默了? -fuz- 给 fuz 发送悄悄话 fuz 的博客首页 (0 bytes) () 02/02/2021 postreply 17:22:14

如果一家公司发一条新闻宣布临床试验药效是XX%,然后对具体数字无可奉告,那不叫真凭实据 -xintian- 给 xintian 发送悄悄话 xintian 的博客首页 (0 bytes) () 02/02/2021 postreply 17:43:48

一共3000 人的样本量,是不是太小了。 -Blue_Snow- 给 Blue_Snow 发送悄悄话 (0 bytes) () 02/02/2021 postreply 17:30:58

一共在十个国家展开三期,阿根廷只是之一。还没来得及查看其它国家的三期资料 -fuz- 给 fuz 发送悄悄话 fuz 的博客首页 (0 bytes) () 02/02/2021 postreply 17:34:01

我废了半天时间真的查不到 -xintian- 给 xintian 发送悄悄话 xintian 的博客首页 (355 bytes) () 02/02/2021 postreply 18:09:09

大约看了一下moderna, 是三万人。 https://www.modernatx.com/sites/default/fil -Blue_Snow- 给 Blue_Snow 发送悄悄话 (0 bytes) () 02/02/2021 postreply 17:38:55

咱中国的疫苗不是应该在中国最好了,再卖给友邦吗。应该在国家批准之前,不能里通外国吧 -Blue_Snow- 给 Blue_Snow 发送悄悄话 (0 bytes) () 02/02/2021 postreply 17:40:31

中国自去年四月份以来,没有几个新冠病例,不可能进行三期临试。只好天南海北的在其它疫情重的国家拉人搞合作。 -fuz- 给 fuz 发送悄悄话 fuz 的博客首页 (74 bytes) () 02/02/2021 postreply 19:17:40

我真是不懂。谢谢指教! -Blue_Snow- 给 Blue_Snow 发送悄悄话 (0 bytes) () 02/02/2021 postreply 20:09:55

详细的efficacy data 在那里? -xintian- 给 xintian 发送悄悄话 xintian 的博客首页 (6361 bytes) () 02/02/2021 postreply 17:41:12

俺这个帖的重点:国药疫苗三期临试的参试者有60+ -fuz- 给 fuz 发送悄悄话 fuz 的博客首页 (0 bytes) () 02/02/2021 postreply 19:20:46

对的,谢谢信息,所以我把以前的帖子删了 -xintian- 给 xintian 发送悄悄话 xintian 的博客首页 (153 bytes) () 02/02/2021 postreply 19:35:38

任何疫苗药物都可以展开三期临床试验, -xintian- 给 xintian 发送悄悄话 xintian 的博客首页 (494 bytes) () 02/02/2021 postreply 17:48:25

Arab nations first to approve Chinese COVID vaccine — despite la -xintian- 给 xintian 发送悄悄话 xintian 的博客首页 (725 bytes) () 02/02/2021 postreply 18:05:37

受教了。最感谢专家们列举证据,这样最有说服力。 -Blue_Snow- 给 Blue_Snow 发送悄悄话 (0 bytes) () 02/02/2021 postreply 18:17:45

两个国家试验的年龄段不一样 -TBz- 给 TBz 发送悄悄话 TBz 的博客首页 (86 bytes) () 02/02/2021 postreply 18:47:48

唉,阿拉伯地区,没几个60+。里面有该国的人口结构 -fuz- 给 fuz 发送悄悄话 fuz 的博客首页 (88 bytes) () 02/02/2021 postreply 19:23:44

你给的是临床三期实验公示的计划/方案/指南,不是具体实施的统计数据。最终的效果评价要看数据。 -欲千北- 给 欲千北 发送悄悄话 欲千北 的博客首页 (0 bytes) () 02/02/2021 postreply 19:20:17

这是招募Volunteers年龄条件范围,但实际参与三期临床试验人的年龄呢? -pickshell- 给 pickshell 发送悄悄话 (0 bytes) () 02/03/2021 postreply 06:55:06

请您先登陆,再发跟帖!