NCT02927444已完成3 期
Multi-Center, Randomized, Double-Blind, Phase III Trial to Assess the Immunogenicity and Safety of Booster Vaccination With NBP606 in Healthy Toddlers (The Extension Study of NBP606_PCVI_III_2013)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 462
- 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 booster 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
- 12 Months 至 15 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy infants who completed 3 doses of primary vaccination (NBP606_PCVI_III_2013), available for follow-ups during the study period.
- •The LAR (Legally Authorized Representative) who understand the requirements of the study and voluntarily consent to participate in the study.
排除标准
- •Administration of other vaccines, except the ones provided in this study, within 1month prior to booster study
- •Known hypersensitivity to any components of the pneumococcal vaccine
- •Any confirmed or suspected immunosuppressive or immunodeficient conditions
- •Coagulation disorder contraindicating IM(intramuscular) vaccination
- •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 booster vaccination
次要结局
- Geometric mean concentration ratio(1 month after the booster vaccination)
研究者
研究点 (1)
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