NCT03363178Unknown1 期
A Single-arm, Open-label, Single-center, Phase 1 Study to Investigate the Safety and Efficacy of GC3107 (BCG Vaccine) After Intradermal Administration in Healthy Adults
适应症
干预措施
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Adverse Event
研究概览
简要总结
Healthy adults will be once administered GC3107(BCG Vaccine) Intradermally.
详细描述
Healthy adults will be once administered GC3107(BCG Vaccine) Intradermally. Tuberculin Skin Test(TST) will be conducted after 84+7 days after IP injection and TST result will be read in 48~72 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults aged 19-64 years old
- •Informed consent form has been signed and dated
- •Able to comply with the requirements of the study
- •Female subjects who have negative results in Urine hCG test at screening, or menopausal women.
排除标准
- •Subjects who have positive results(;induration diameter over 5mm) in Tuberculin Skin Test(TST) at screening
- •Subjects who shown abnormal results(including inactive tuberculosis) on Chest X-ray at screening
- •Subjects who received a vaccination(including live vaccine) within 28 days before enrollment
- •Subjects who are on antituberculosis drugs
- •Immunocompromised subjects with immunodeficiency disease or subjects receiving immunosuppressive or immunomodulating therapy
- •Subjects with severe chronic disease who are considered by investigator to be ineligible for the study
- •Pregant or lactating women
研究组 & 干预措施
GC3107
Experimental
BCG Vaccine, 0.1mL
干预措施: GC3107 (Biological)
结局指标
主要结局
Adverse Event
时间窗: for 7 days from Day0/during study period
Solicited/Unsolicited Adverse Event
次要结局
- Whether the maximum Erythema/Redness diameter greater than 5mm after TST.(Day0+84days)
- Maximum diameter of Erythema/Redness after TST.(Day0+84days)
- Maximum diameter variation of Induration after TST.(Day0+84days)
- Whether the maximum Induration diameter greater than 5mm after TST.(Day0+84days)
- Maximum diameter of Induration after TST.(Day0+84days)
- Maximum diameter variation of Erythema/Redness after TST.(Day0+84days)
研究者
研究点 (1)
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