TCTR20220524004已完成4 期
Immunogenicity and reactogenicity of fractionated-dose intradermal vs standard intramuscular tozinameran as the fourth COVID-19 vaccine dose in patients with immune-mediated dermatologic diseases: a single-blinded randomised-controlled parallel-grouped non-inferiority trial
Faculty of Medicine Ramathibodi Hospital0 个研究点目标入组 109 人开始时间: 2022年5月24日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 109
研究概览
简要总结
The intradermal BNT162b2 vaccine is a viable booster option for IMDD patients troubled by post-vaccination fever; its role in mitigating the risk of flare-ups remains unclear.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 N/A (No limit)（—）
- 性别
- All
入选标准
- •1.Aged equal to or more than 18 years
- •2.Diagnosed with psoriasis or autoimmune bullous diseases
- •3.Completed two-doses of the primary vaccine series and the third booster dose lasted for more than three months
- •4.Agree to receive the fourth COVID-19 vaccine dose as tozinameran
排除标准
- •1.History of previous COVID-19 infection
- •2.Positive result of COVID-19 rapid antigen test (tested upon recruitment prior to vaccination)
- •3.Uncontrolled disease activity
- •4.Non-dermatologic immune-mediated diseases
- •5.Congenital or acquired immunodeficiency syndrome
- •7.Pregnant women
- •8.Allergy to components of tozinameran
- •9.Inability to give written informed consent to participate in the study
研究者
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