CTRI/2020/04/024749已完成3 期
A Multicenter, Phase III, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy of Recombinant BCG VPM1002 in Reducing Infection Incidence and Disease Severity of SARS-COV-2/COVID-19 Among High-Risk Subjects
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 6,041
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.Male or Female subjects = 18 years of age at high-risk of SARS-CoV-2/COVID-19 infection
- •2.Test negative for SARS-CoV-2 infection (RT-PCR test) at screening
- •3.Capable of giving informed consent
排除标准
- •1.Previous history of Tuberculosis or known active Mycobacterium tuberculosis infection
- •2.Received BCG vaccine within one year prior to screening
- •3.Fever (greater than or equal to 38 ºC/100.4°F) or any other respiratory symptoms/illnesses within the past 14 days
- •4.Pregnant or lactating women
- •5.Women of child-bearing potential not agreeing to use adequate contraception
- •6.Current active viral or bacterial infection
- •7.Expected vaccination during the study period, independently of the type of vaccination
- •8.Severely immunocompromised subjects.
- •9.Active solid or non-solid malignancy or lymphoma within the prior two years
- •10.Individuals known to be hypersensitive to any component of the vaccine
- •11.Eczema or other significant skin lesion or infection at the site/s of injection.
- •12.Any other medical condition which in the opinion of the investigator may affect the subject’s safety or study participation and conduct
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