Long-Term Efficacy of Pneumococcal Conjugate 7-Valent Vaccine Versus Plain Polisaccharide Pneumococcus Vacine in Reducing Pneumococcal Nasopharyngeal Carriage of Children.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 主要终点
- To compare the ability of Prevnar® to Pneumo® 23 in reducing and preventing nasopharyngeal carriage of vaccine-type pneumococci one year after respective immunization.
研究概览
简要总结
To compare the ability of Prevnar® to Pneumo® 23 in reducing and preventing nasopharyngeal carriage of vaccine-type pneumococci one year after respective immunization. To evaluate the rate of penicillin-resistant pneumococci in nasopharyngeal carriage.
详细描述
This study will require 6 months to be completed (3 months for nasopharyngeal samples collection; 3 months dor analysis). Each child will participate for a 1 day period.
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
- None
入排标准
- 年龄范围
- 2 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy children between
- •2 to 9 years old.
- •No history of antibiotic use prior 1 month of enrollment
- •No history of invasive pneumococcal disease
排除标准
- 未提供
研究组 & 干预措施
G1
G1: prevenar
干预措施: pneumococcus conjugate vaccine 7 valent to reduce carriage (Biological)
G2
G2: pneumo 23
干预措施: pneumococcus conjugate vaccine 7 valent to reduce carriage (Biological)
结局指标
主要结局
To compare the ability of Prevnar® to Pneumo® 23 in reducing and preventing nasopharyngeal carriage of vaccine-type pneumococci one year after respective immunization.
时间窗: 12 months
次要结局
- To evaluate the rate of penicillin-resistant pneumococci in nasopharyngeal carriage.(12 months)