NCT00119743终止3 期
Assess, in Young Children, the Efficacy in Preventing Acute Otitis Media (AOM) of GSK Biologicals Undecavalent Pneumococcal-protein D Conjugate Vaccine, When Administered as a Three Dose Primary Vaccination Course During the First Year of Life With a Booster Dose in the Second Year of Life.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 5,000
- 试验地点
- 42
- 主要终点
- To demonstrate the efficacy of the 11 Pn-PD vaccine in preventing AOM caused by vaccine-type pneumococcus in fully vaccinated children less than 2 years of age.
研究概览
简要总结
The purpose of this study is to assess the efficacy in young children in preventing acute otitis media due to vaccine serotype pneumococcal or non typable Hemophilus influenza, following immunization with an 11-valent pneumococcal vaccine according to a 3 dose primary vaccination in the first year of life, with booster dose in the second year of life. Prophylactic immunization with pneumococcal conjugate vaccine is compared to placebo (hepatitis A 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
- 6 Weeks 至 27 Months(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female between 6 weeks and 5 months (42-152 days) of age at the time of first vaccination.
排除标准
- •Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
结局指标
主要结局
To demonstrate the efficacy of the 11 Pn-PD vaccine in preventing AOM caused by vaccine-type pneumococcus in fully vaccinated children less than 2 years of age.
次要结局
- To assess the efficacy of the 11 Pn-PD vaccine in preventing AOM caused by NTHI in fully vaccinated children less than 2 years of age.
研究者
研究点 (42)
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