JPRN-jRCT2071200110已完成1 期
A Phase 1/2 study to assess the safety, immunogenicity and recommended dose of DS-5670a (COVID-19 Vaccine) in Japanese healthy adults and elderly subjects
Inoguchi Akihiro0 个研究点目标入组 152 人开始时间: 2021年3月10日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 152
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
- >= 20age old 至 < 75age old(—)
- 性别
- All
入选标准
- •1) Japanese
- •2) Healthy adults aged >=20 and <65 years, or healthy elderly aged >=65 and <75 years (at the time of informed consent)
- •3) Body Mass Index (BMI) is >=17.5 and <30.0 kg/m^2 (at screening )
- •4) Subjects who can follow the compliance requirements during clinical trials, undergo medical examinations and tests specified by the protocol, and report symptoms, etc.
排除标准
- •1) Having a history of anaphylaxis or severe allergies due to food, cosmetics, medicines, or vaccination.
- •2) Having alcohol or drug dependence.
- •3) Having a history of immunodeficiency or having a close relative with congenital immunodeficiency.
- •4) Having a history of SARS-CoV-2 infection.
- •5) Having fever of >=39.0 C or symptoms of suspected allergies such as systemic rash within 2 days after past vaccination.
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