揭底：國藥滅活疫苗三期臨試的年齡範圍

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:

Laboratorio Elea Phoenix S.A. 

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.

 

 

 

 

所有跟帖： 

• 欸，發了這麽久，咋沒人來嗆嗆。八掛閑扯都那麽來勁，看到真憑實據就都沉默了？ -fuz- ♂ (0 bytes) () 02/02/2021 postreply 17:22:14

• 如果一家公司發一條新聞宣布臨床試驗藥效是XX%，然後對具體數字無可奉告，那不叫真憑實據 -xintian- ♀ (0 bytes) () 02/02/2021 postreply 17:43:48

• 一共3000 人的樣本量，是不是太小了。 -Blue_Snow- ♀ (0 bytes) () 02/02/2021 postreply 17:30:58

• 一共在十個國家展開三期，阿根廷隻是之一。還沒來得及查看其它國家的三期資料 -fuz- ♂ (0 bytes) () 02/02/2021 postreply 17:34:01

• 我廢了半天時間真的查不到 -xintian- ♀ (355 bytes) () 02/02/2021 postreply 18:09:09

• 大約看了一下moderna, 是三萬人。 https://www.modernatx.com/sites/default/fil -Blue_Snow- ♀ (0 bytes) () 02/02/2021 postreply 17:38:55

• 咱中國的疫苗不是應該在中國最好了，再賣給友邦嗎。應該在國家批準之前，不能裏通外國吧 -Blue_Snow- ♀ (0 bytes) () 02/02/2021 postreply 17:40:31

• 中國自去年四月份以來，沒有幾個新冠病例，不可能進行三期臨試。隻好天南海北的在其它疫情重的國家拉人搞合作。 -fuz- ♂ (74 bytes) () 02/02/2021 postreply 19:17:40

• 我真是不懂。謝謝指教！ -Blue_Snow- ♀ (0 bytes) () 02/02/2021 postreply 20:09:55

• 詳細的efficacy data 在那裏？ -xintian- ♀ (6361 bytes) () 02/02/2021 postreply 17:41:12

• 俺這個帖的重點：國藥疫苗三期臨試的參試者有60＋ -fuz- ♂ (0 bytes) () 02/02/2021 postreply 19:20:46

• 對的，謝謝信息，所以我把以前的帖子刪了 -xintian- ♀ (153 bytes) () 02/02/2021 postreply 19:35:38

• 任何疫苗藥物都可以展開三期臨床試驗， -xintian- ♀ (494 bytes) () 02/02/2021 postreply 17:48:25

• Arab nations first to approve Chinese COVID vaccine — despite la -xintian- ♀ (725 bytes) () 02/02/2021 postreply 18:05:37

• 受教了。最感謝專家們列舉證據，這樣最有說服力。 -Blue_Snow- ♀ (0 bytes) () 02/02/2021 postreply 18:17:45

• 兩個國家試驗的年齡段不一樣 -TBz- ♂ (86 bytes) () 02/02/2021 postreply 18:47:48

• 唉，阿拉伯地區，沒幾個60+。裏麵有該國的人口結構 -fuz- ♂ (88 bytes) () 02/02/2021 postreply 19:23:44

• 你給的是臨床三期實驗公示的計劃/方案/指南，不是具體實施的統計數據。最終的效果評價要看數據。 -欲千北- ♂ (0 bytes) () 02/02/2021 postreply 19:20:17

• 這是招募Volunteers年齡條件範圍，但實際參與三期臨床試驗人的年齡呢? -pickshell- ♀ (0 bytes) () 02/03/2021 postreply 06:55:06