NCT01402713已完成2 期
Randomized, Double Blind, Multicenter, Phase II/III Study to Evaluate the Effectiveness(Immunogenicity) and Safety of 'GC1107' Administered Intramuscularly in Healthy Children
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 311
- 试验地点
- 1
- 主要终点
- Step I-the seroprotection rate of diphtheria and tetanus
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness(immunogenicity) and safety of 'GC1107' administered intramuscularly in healthy children
详细描述
Randomized, double blind, multicenter, phase Ⅱ/Ⅲ 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
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy Korean children(age: 10 ~ 17)
- •In the case of step1 (for step 1) 11~12 years
- •who got the basic vaccination(5 times vaccination of diphtheria and tetanus until 6 years old.)
- •Subjects willing to provide written informed consent and able to comply with the requirements for the study or informed consent was obtained from the subject's legal guardian
排除标准
- •Subjects with antitoxin of diphtheria and tetanus ≥1.0IU/mL (ELISA)
- •only applicable in step 1
- •subjects who have not recovered from the acute disease within 2 weeks
- •who has experienced the temporary platelet decrease or has the medical history of neurologic complication
- •who has the medical history of allergic disease related to the components of investigational drug
- •who has experienced the severe adverse events for the diphtheria and tetanus vaccination
- •who got the vaccination of diphtheria and tetanus within 5 years
- •who has not recovered from the acute disease within 2 weeks
- •who got the treatment of blood product within 3 months
- •who got the immunoglobulin should have the wash-out period
- •who be infected from the diphtheria and tetanus
- •Subjects who are scheduled to participate in other clinical trial studies during the study.
- •Current participation in a clinical study involving any other drugs including vaccine within 4 weeks of enrollment of the study vaccine.
- •Subjects who have participated in any other clinical trials within 4 weeks of the administration of the study
- •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 37.5) 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.
结局指标
主要结局
Step I-the seroprotection rate of diphtheria and tetanus
时间窗: 28 days
Number of participants after vaccination as a measure of the effectiveness
Step II-to assess noninferior of diphtheria and tetanus
时间窗: 28 Days
次要结局
- Step II-GMT of diphtheria and tetanus(28 days)
- Step II-safety assessment-solicited adverse event(28 days)
- Step II- Boosting response of diphtheria and tetanus(28)
- StepI-GMT of diphtheria and tetanus(28 days)
- Step I-safety assessment-solicited adverse event(42 days)
研究者
研究点 (1)
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