NCT00370318已完成3 期
Multicentre Study to Assess the Effect of Prophylactic Antipyretic Treatment on the Rate of Febrile Reactions Following Concomitant Administration of GSK Biologicals' 10-valent Pneumococcal Conjugate, Infanrix Hexa and Rotarix Vaccines
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 11
- 主要终点
- Occurrence of fever > or = to 38°C (rectal temperature)
研究概览
简要总结
The purpose of this trial is to assess if the rate of febrile reactions following the co-administration of pneumococcal conjugate vaccines with standard infant vaccines is lowered when paracetamol is given prophylactically.
详细描述
2 groups (200 per group); control group receives no prophylactic antipyretic treatment.
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
- 9 Weeks 至 16 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy children 9-16 weeks old and born after a gestation of at least 36 weeks.
排除标准
- •Body weight < 4.5 kg
- •Children having received or planning to receive any investigational or non-registered products, vaccines not foreseen in the protocol, and immune modifying drugs
- •Children with any disease that affects the immune system or gastro-intestinal tract
- •Children with a history of seizures, allergic disease, or disease(s) covered by the vaccines
- •Children with contraindication to paracetamol treatment.
结局指标
主要结局
Occurrence of fever > or = to 38°C (rectal temperature)
次要结局
- Safety, reactogenicity and immunogenicity pre and post-vaccination
研究者
研究点 (11)
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