NCT00158795已完成4 期
Assess the Safety & Reactogenicity of GSK Biologicals Hib Vaccine Co-administered With Chinese Local DTPw Vaccine When Compared to Chinese Local DTPw Vaccine Administered Alone, in Healthy Infants at 3,4 & 5 Mths of Age
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 454
- 试验地点
- 1
- 主要终点
- Occurrence of solicited symptoms of grade 3 intensity, during the specific follow-up period after vaccination.
研究概览
简要总结
To assess safety and reactogenicity of GSK Biologicals' Haemophilus influenza type b vaccine co-administered with or without Chinese DTPw vaccine administered alone in healthy infants (3, 4 and 5 months of age)
详细描述
All subjects will be randomized into two groups. One group will receive DTPw vaccine co-administered with Hib and another group will receive DTPw vaccine alone. A specific follow-up of solicited local and general symptoms after each vaccination. A specific follow-up of unsolicited symptoms after each vaccination. Recording of serious adverse events reported during the study 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
- 3 Months 至 4 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A male or female infant between, and including, 11 and 17 weeks of age at the time of the first vaccination.
排除标准
- •Planned administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the first vaccine dose and ending 30 days after the last dose.
- •Chronic administration of immunosuppressants or other immune-modifying drugs from birth until administration of first dose of study vaccine.
- •Use of any investigational or non-registered product (drug or vaccine) 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
Occurrence of solicited symptoms of grade 3 intensity, during the specific follow-up period after vaccination.
次要结局
- - Occurrence of solicited symptoms during the specific follow up period after vaccination.
- - Occurrence of unsolicited symptoms during the specific follow up period after vaccination.
- - Occurrence of serious adverse events during the study period.
研究者
研究点 (1)
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