12-15岁年龄组,没有单独做。5-11岁做了,还没看到结果

来源: fuz 2021-06-26 11:02:52 [] [博客] [旧帖] [给我悄悄话] 本文已被阅读: 次 (1895 bytes)
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回答: 看看這篇violinpiano2021-06-26 10:11:05

5-11 岁

https://clinicaltrials.gov/ct2/show/NCT04816643

 

Phase 1 is the open-label dose-finding portion of the study to evaluate safety, tolerability, and immunogenicity of BNT162b2 on a 2-dose (separated by approximately 21 days) schedule in up to 3 age groups (participants ≥5 to <12 years, ≥2 to <5 years, and ≥6 months to <2 years of age). Dose finding is being initiated in this study in participants ≥5 to <12 years of age based on the acceptable blinded safety assessment of the 30-μg dose in 12- to 15-year-olds in the C4591001 study.

The purpose of Phase 1 is to identify preferred dose level(s) of BNT162b2 from up to 3 different dose levels in each age group.

 

 

12-15岁,与成年组混在一起

https://clinicaltrials.gov/ct2/show/NCT04368728

在决定剂量的一期临试中,没有包括18岁以下的。12-15岁组,从二期开始加入。这就是为啥俺说厂家“偷工”。

  • In 3 age groups (Phase 1: 18 to 55 years of age, 65 to 85 years of age; Phase 2/3: ≥12 years of age [stratified as 12-15, 16-55 or >55 years of age]).
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