NCT00294294已完成4 期
A Randomized Controlled Open-Label Phase IV Multi Center Study to Assess the Effect of Antipyretic Prophylactic Treatment on the Rate of Febrile Reactions Following Concomitant Contralateral Administration of a 7-Valent Pneumococcal Conjugate Vaccine (Prevenar®) and DTPa-HBV-IPV+Hib Vaccine (Infanrix Hexa®) in Children at 2, 3, 4 and 11-14 Months of Age
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 300 人开始时间: 2005年5月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 主要终点
- Rectal temperature >= 38°C within days 1-4 post vaccination after any of the doses 1-4
研究概览
简要总结
The purpose of the study is to determine whether prophylactic antipyretic treatment after vaccination with Prevenar and a concomitant hexavalent DTPa combination vaccine reduces the rate of febrile reactions.
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
- 56 Days 至 112 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy infants age 55 to 112 days
- •Subject's parents/legal guardians provide written informed consent
排除标准
- •Prematurely born subjects < 37 weeks gestation
- •Known or suspected disease of immune system
- •Known or suspected hypersensitivity to any vaccine or vaccine component
结局指标
主要结局
Rectal temperature >= 38°C within days 1-4 post vaccination after any of the doses 1-4
次要结局
- Rectal temperature > 39.0°C occurring within 4 days of vaccine administration after each of the doses 1-4
研究者
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