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
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.
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.
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.
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
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.
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.
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。
Arab nations first to approve Chinese COVID vaccine — despite lack of public data
https://www.nature.com/articles/d41586-020-03563-z
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。
数据的汇总和统计如何按既定方式进行?
看来你真的不咋懂这方面的事啊
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。