KCT0001240已完成未知
A randomized, double-blinded, controlled, Phase I clinical trial to assess the safety, tolerability and immunogenicity of‘NBP607 (Trivalent Inactivated Cell-Culture Influenza Vaccine)’compared to egg-based influenza vaccine in healthy adult volunteers
SK Chemicals0 个研究点目标入组 100 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 59(Year)（—）
- 性别
- All
入选标准
- •1) Healthy adults aged 20 to 59 years who can be followed up during study period.
- •2) The subjects who gave written consent to participate in the study voluntarily and comply with all study requirements.
- •3) If the subject is female,she must be of post-menopausal and the subject has a negative urine pregnancy test result on screening.
排除标准
- •1) Subjects who are hypersensitive to any component of vaccine, i.e., eggs, chicken or chicken products.
- •2) Subjects with immune deficiency disorder.
- •3) Prior personal history of Guillain-Barre syndrome.
- •4) Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
- •5) Subjects who experienced fever within 24 hours before vaccination or with the febrile disease(axillary temperature exceeding 37.5?) on the visit date or with acute respiratory infection.
- •6) Subjects who had received immunosuppressant or immune modifying drug within 3 months before screening.
- •7) Subjects who had received blood products or immunoglobulin within 3 months before screening.
- •8) Subjects who had received influenza vaccination within 6 months prior to the screening.
- •9) Subjects who had received other vaccination within a month before screening, or those who had another vaccination scheduled within a month after vaccination with the investigational product.
- •10) Subjects who had participated in other clinical trial within 4 weeks prior to vaccination with the investigational product.
- •11) Subjects who had done blood donation within a week prior to vaccination with the investigational product or are planning to within 7 months.
- •12) Subjects with clinically significant chronic disease(e.g.; cardiovascular disease except for controlled hypertension, respiratory disease, metabolic disease, renal dysfunction or hemoglobinopathy etc.) or malignant cancer.
- •13) Child-bearing women, Pregnant women, breast-feeding women.
- •14) Subjects with other clinically significant medical or psychological condition, who in the investigator's opinion may not suitable in participating in the study.
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