NCT02201030已完成3 期
Multi-Center, Randomized, Double-Blind, Phase III Trial to Assess the Immunogenicity and Safety of Primary Vaccination With NBP606 in Healthy Infants
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 577
- 试验地点
- 1
- 主要终点
- Proportion of subjects with the targeted antibody concentration
研究概览
简要总结
This study will assess the immunogenicity and safety of primary vaccination with NBP606 compared to the existing commercial vaccine, when given concomitantly with routine pediatric vaccinations.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 42 Days 至 98 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Infants between 42 and 98 days of age (approximately 2 months) at the time of enrollment.
- •The LAR (Legally Authorized Representative) who understand the requirements of the study and voluntarily consent to participate in the study.
排除标准
- •Known hypersensitivity to any components of the pneumococcal vaccine
- •Any confirmed or suspected immunosuppressive or immunodeficient conditions
- •Coagulation disorder contraindicating IM(intramuscular) vaccination
- •Subject has received any licensed vaccine(not including BCG and Hepatitis B)
- •Participation to another study
结局指标
主要结局
Proportion of subjects with the targeted antibody concentration
时间窗: 1 month after the primary vaccination
次要结局
- Geometric mean concentration ratio(1 month after the primary vaccination)
研究者
研究点 (1)
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