TCTR20190325003尚未招募3 期
A Multi-national, Multi-center, Randomized, Double-Blind, Active-Controlled, Phase III Study to Investigate the Efficacy and Safety of ‘GC3107 (BCG Vaccine)’ after Intradermal Administration in Healthy Infants
Green Cross Coporation0 个研究点目标入组 750 人开始时间: 2019年3月25日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 750
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
- 0 Days 至 4 Weeks（—）
- 性别
- All
入选标准
- •1)Subject's legally acceptable representatives had this clinical trial information explained to them and understood it, voluntarily decided participation, and provided informed consent
- •2)Healthy infants aged ≤ 4 weeks
- •3)Body weight ≥2,500 g at birth
- •4)Born after normal gestation (≥37 weeks)
排除标准
- •1)Had contact with patients with a confirmed diagnosis of active pulmonary tuberculosis
- •2)Any symptoms or signs of active tuberculosis infection or current treatment of tuberculosis at screening (Visit 1)
- •3)History of confirmed tuberculosis
- •4)Acute fever with tympanic temperature ≥38.0 ℃ within 24 hours prior to administration of the investigational product, or an active infectious disease at screening (Visit 1)
- •(However, subjects with tympanic temperature ≥38.0 ℃ within 24 hours prior to administration of the investigational product may be rescreened only once, and subjects with mild acute diseases such as mild fever, mild respiratory infection, otitis media, and diarrhea may be permitted to be vaccinated at the judgment of the investigator.)
- •5)Hypothermia with tympanic temperature <36.0 ℃ within 24 hours prior to administration of the investigational product
- •(However, subjects with tympanic temperature <36.0 ℃ within 24 hours prior to administration of the investigational product may be rescreened only once.)
- •6)Clinically suspected neonatal sepsis
- •7)Born with severe congenital anomaly that may affect the efficacy or safety result of this clinical trial as judged by the investigator
- •8)Severe skin disease or burn at the injection site of investigational product
- •9)The subject's mother had human immunodeficiency virus (HIV)-positive result on prenatal testing
- •10)The subject’s mother received immune modifying drug, immunosuppressant, or TNF inhibitor during pregnancy or lactation
- •11)Known immunodeficiency disease or incomplete immune function (i.e., hypogammaglobulinemia) or family history of such disease
- •12)Immunocompromised state due to immunosuppressant, anti-cancer drug or radiotherapy prior to screening (Visit 1), or prolonged use of systemic corticosteroids (prednisone equivalent dose of ≥2 mg/kg/day for body weight ≤10 kg, or prednisone equivalent dose of ≥20 mg/day for body weight >10 kg; Used continuously for ≥2 weeks. However, inhaled, intranasal or local administration of corticosteroids is permitted regardless of the dose used.)
- •13)History of other vaccines including BCG vaccine prior to screening (Visit 1), with an exception of Hepatitis B vaccine according to the national standard vaccination schedule
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