跳至主要内容
临床试验/NCT00119743
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.

GlaxoSmithKline42 个研究点 分布在 2 个国家目标入组 5,000 人开始时间: 2000年10月1日最近更新:
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

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

申办方类型
Industry
责任方
Sponsor

研究点 (42)

Loading locations...

相似试验