CTRI/2020/08/027170已完成2 期
A Phase 2/3, Observer-Blind, Randomized, Controlled Study to Determine the Safety and Immunogenicity of Covishield (COVID-19 Vaccine) in Healthy Indian Adults - ICMR/SII-COVISHIELD
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,600
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
入选标准
- •1. Healthy adults aged more than or equal to 18 years of either sex.
- •2. Written informed consent by participants.
- •3. The participant is resident of the study area and is willing to comply with study protocol requirements.
- •4. Healthy, as determined by medical history and physical examination.
- •5. Female participants of childbearing potential must have a negative urine pregnancy test within 24 hours prior to study vaccine administration.
排除标准
- •1. Acute illness with or without fever at the time of study vaccine administration
- •2. History of laboratory confirmed COVID-19 disease in household contact or close workplace contact
- •3. IgG seropositivity to SARS-CoV-2
- •4. History or currently positive for SARS-CoV-2 by RT-PCR
- •5. History of severe allergic reactions after previous vaccinations or hypersensitivity to any component of study vaccines
- •6. Any confirmed or suspected condition with impaired/altered function of immune system
研究者
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