NCT02361866已完成3 期
Randomized, Double Blind, Multicenter, Phase III Study to Evaluate the Effectiveness(Immunogeneicity) and Safety of 'GC1107' Administered Intramuscularly in Healthy Adults
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 376
- 试验地点
- 1
- 主要终点
- seroprotection rate of diphtheria and tetanus
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness(immunogeneicity) and safety of 'GC1107' administered intramuscularly in healthy Adults.
详细描述
Randomized, double blind, multicenter, phaseⅢ study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy Korean adults (age: over 18 years)
- •who got the basic vaccination of DTP(Diphtheria, tetanus, pertussis) in the past
- •Subjects willing to provide written informed consent and able to comply with the requirements for the study
排除标准
- •subjects who have already got the additional vaccination of Td within 5 years
- •subjects with antitoxin of diphtheria and tetanus ≥1.0 IU/mL (ELISA)
- •only applicable in step I
- •subjects who have not recovered from the acute disease within 2 weeks
- •subjects who have the medical history of allergic disease related to the components of investigational drug
- •who got the treatment of blood product and immunoglobulin product within 3 months
- •females who are pregnant
- •females who are breastfeeding
- •subjects who are infected from the diphtheria and tetanus
- •subjects who have experienced the severe adverse events for the diphtheria and tetanus vaccination
- •Subjects who are scheduled to participate in other clinical trial studies during the study
- •Subjects who have participated in any other clinical trials within 4 weeks of the administration of the study
- •Those who take the other medicine that affects this study or are vaccinated other vaccines
- •Subject who have received adrenocortical hormones or immunosuppressive drug within 4weeks of enrollment
- •Subjects with a history of chronic disease obstacles to the study.
- •Subjects who have episode of acute febrile (at least 37.4) after injection of vaccine during the study
- •Subject who have plan of operation during the study.
- •Individuals with other clinically significant medical or psychological condition who are considered by the investigator to be ineligible for the study.
研究组 & 干预措施
Tetanus and Diphtheria(Td vaccine)
Active Comparator
0.5ml, intramuscular, a single dosing
干预措施: Tetanus and Diphtheria(Td vaccine) (Biological)
GC1107
Experimental
0.5ml, intramuscular, a single dosing
干预措施: GC1107 (Biological)
结局指标
主要结局
seroprotection rate of diphtheria and tetanus
时间窗: 28days
次要结局
- GMT (Geometric Mean Titer)(28days)
- solicited adverse events(7days)
- Boosting response of diphtheria and tetanus compared participants with before and after the injection(28days)
- Seroprotection rate according to the respective age group(28days)
- GMT according to the respective age group(28days)
- unsolicited adverse events(28 days)
研究者
研究点 (1)
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