JPRN-jRCT2071210106已完成2 期
A Randomized, Active-comparator, Observer-blind, Phase I/II/III Study to Demonstrate the Immunogenicity of a Single Booster Dose of DS-5670a in Adults and Elderly Received a Primary Series of Approved COVID-19 Vaccine
Inoguchi Akihiro0 个研究点目标入组 5,028 人开始时间: 2021年12月28日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5,028
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1)Adults aged 18 to 64 years at the time of consent, or elderly subjects aged 65 years or older at the time of consent.
- •2)Subjects who had received the 2nd dose of the initial series of SARS-CoV-2 vaccines (either Comirnaty or Spikevax[previously Moderna]) at least 6 months prior to signing consent.
排除标准
- •1)Subjects who have a history of seizure or epilepsy after vaccination.
- •2)Subjects who have had symptoms of SARS-CoV-2 infection and been diagnosed with SARS-CoV-2 infection by reverse transcription polymerase chain reaction (RT-PCR) test, SARS-CoV-2 antigen test, or SARS-CoV-2 antibody test in the past.
- •3)Subjects who have suggestive symptoms of SARS-CoV-2 infection (respiratory symptoms, headache, malaise, olfactory dysfunction, or taste disorder, etc.) at the time of consent.
- •4)Subjects who have a positive SARS-CoV-2 antigen test or SARSCoV-2 antibody test at the time of eligibility assessment.
- •5)Subjects who have a history of anaphylaxis or severe allergy to food, pharmaceuticals, cosmetics, vaccination, etc.
研究者
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