揭底:国药灭活疫苗三期临试的年龄范围

f
fuz
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.

 

 

 

 

f
fuz
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?
B
Blue_Snow
一共3000 人的样本量,是不是太小了。
f
fuz
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
B
Blue_Snow
大约看了一下moderna, 是三万人。 https://www.modernatx.com/sites/default/fil
B
Blue_Snow
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
x
xintian
详细的efficacy data 在那里?

南美3000 人得试验到现在也没有详细的efficacy 数据出来呢?BBC 英文报道和您贴的中文报道好像跟不是一码事一样

https://www.bbc.com/news/world-asia-china-55212787

 

数据,数据在哪里?

Sinopharm announced on 30 December that phase three trials of the vaccine showed that it was 79% effective - lower than that of Pfizer and Moderna. 

However, the United Arab Emirates, which approved a Sinopharm vaccine earlier this month, said the vaccine was 86% effective, according to interim results of its phase three trial.

 company spokeswoman declined to explain the discrepancy, and said detailed results would be released later, said a Reuters report.

But even ahead of the phase three trial results, the vaccine had already been distributed to nearly a million people in China under an emergency programme. 

Professor Dale Fisher, of the National University of Singapore, said then that it was "unconventional" to ramp up a vaccine programme without first going through last stage trials. 

"It is normal to wait for an analysis of phase three trials before ramping up a vaccine programme through emergency use authorisation," he told news site CNBC.

x
xintian
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
x
xintian
任何疫苗药物都可以展开三期临床试验,

如果你查clinicaltrial.gov 官网,三期临床

https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html

目前ongoing的三期临床疫苗试验有20个。展开了试验没有详细公布数据出来,药效学和安全都不做数。

x
xintian
Arab nations first to approve Chinese COVID vaccine — despite la

Arab nations first to approve Chinese COVID vaccine — despite lack of public data

https://www.nature.com/articles/d41586-020-03563-z

 

 

x
xintian
我废了半天时间真的查不到

用sinopharm clinical trial result 查了,无法查到data。新闻不算。

中文网页新闻轰轰烈烈的陈薇疫苗cansino 也无论如何也查不到数据。这个也是有三期临床试验在做的。开始的最早,目前什么数据都没有。J&J, Novavax, 9九月才开始的试验,结果都出来了。

B
Blue_Snow
受教了。最感谢专家们列举证据,这样最有说服力。
T
TBz
两个国家试验的年龄段不一样

数据的汇总和统计如何按既定方式进行?

 

f
fuz
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。

看来你真的不咋懂这方面的事啊

 

欲千北
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。
f
fuz
俺这个帖的重点:国药疫苗三期临试的参试者有60+
f
fuz
唉,阿拉伯地区,没几个60+。里面有该国的人口结构

x
xintian
对的,谢谢信息,所以我把以前的帖子删了

以后我不会发推测性质的帖子。谢谢指正。就发以事实为中心的贴,

希望sinopharm 数据可以公布。

B
Blue_Snow
我真是不懂。谢谢指教!
p
pickshell
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?