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临床试验/TCTR20210826001
TCTR20210826001已完成不适用

Reactogenicity and immunogenicity of mRNA COVID-19 vaccine (ComirnatyTM) among Thai adolescent with chronic diseases

Pediatric Infectious Disease Society of Thailand (PIDST)0 个研究点目标入组 300 人开始时间: 2021年8月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
300

研究概览

简要总结

Our findings show that adolescents with impaired immunity had a poor immune response after the 2-dose of BNT162b2 vaccination, and require an additional dose as recommended by the Advisory Committee on Immunization Practices. For adolescents with other chronic diseases, 2-dose of BNT162b provide high neutralizing antibody up to 3 to 6 m post vaccination. However, with the era of Omicron variants, with immune escape, a booster dose should also be considered.

研究设计

研究类型
Observational

入排标准

年龄范围
12 Years 至 18 Years(—)
性别
All

入选标准

  • Adolescence between 12-18 years of age at the enrollment date
  • No history of COVID-19 vaccination
  • No history of COVID-19 infection

排除标准

  • Acute fever with body temperature above 37.8 degree Celsius within 3 days
  • History of drug anaphylaxis or vaccine ingredient allergy
  • History of lived vaccine administration within 4 weeks

研究者

发起方
Pediatric Infectious Disease Society of Thailand (PIDST)

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