NCT00142389已完成1 期
Comparison of Maternal and Infant Immunization Strategies to Prevent Pneumococcal Disease
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 680
- 试验地点
- 1
- 主要终点
- Serum anti pneumococcal polysaccharide IgG antibody at 20 weeks of age
研究概览
简要总结
This prospective randomized evaluation of pneumococcal vaccine immunization of pregnant mothers, followed by pneumococcal conjugate immunization of their children is designed to assess the effects of these strategies on the immunogenicity and safety of both vaccines. We hypothesize that maternal followed by infant immunization will be safe and will provide higher levels of antibody from birth through 12 months of age.
详细描述
This is a randomized vaccine evaluation in 4 groups of mothers and their infants, to assess the effect of maternal immunization on the infants' response to pneumococcal vaccine.
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
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Mothers from 18 to 14 years of age in the third trimester of pregnancy,
- •with normal medical and obstetric history,
- •who plan to deliver their infant in Dhaka city and remain there for 12m
排除标准
- •Maternal history of systemic disease,
- •Maternal history of previous complicated pregnancies, preterm delivery, abortions, or birth with congenital anomalies.
- •Maternal hypersensitivity to any vaccination, or
- •Maternal receipt of pneumococcal vaccine in the last 3 years.
结局指标
主要结局
Serum anti pneumococcal polysaccharide IgG antibody at 20 weeks of age
local and systemic reactions within 2 weeks of vaccination
次要结局
- Level and duration of serum IgG antibody to pneumococcus up to 1 year of age.
研究者
研究点 (1)
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