Effectiveness and Costs of Combined Influenza and Pneumococcal Vaccination in Pre-School Children With Recurrent Respiratory Tract Infections (RTI): a General Practice-Based Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- UMC Utrecht
- 入组人数
- 660
- 试验地点
- 2
- 主要终点
- number of febrile RTI-episodes
研究概览
简要总结
The PRIMAKid trial is a general practice based double-blind randomized placebo-controlled trial on the effectiveness and costs of combined influenza and pneumococcal vaccination in pre-school children with recurrent respiratory tract infections. A target number of 660 children aged 18-72 months with a history of two or more general practitioner attended episodes of RTI, are included. Exclusion criteria are diseases accompanied by a high risk of recurrent RTI and conditions chronically treated with corticosteroids. Over a period of 7 to 22 months follow-up, the number of febrile RTI-episodes as primary outcome is assessed, and as secondary outcomes the severity and length of febrile RTI-episodes, medical visits / interventions, health-related quality of life and productivity loss of parents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double
入排标准
- 年龄范围
- 18 Months 至 72 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18-72 months
- •A history of two or more episodes of general practitioner attended RTIs
排除标准
- •No intention to move within 12 months to another region
- •Provision of informed consent
- •Good mastering of the Dutch language
- •Absence of chronic diseases such as asthma treated with corticosteroids or high-risk disease (such as palatoschisis, Down syndrome, cystic fibrosis, etc.)
- •No previous influenza vaccination or pneumococcal vaccination or Hepatitis B vaccination
- •No hypersensitivity to eggs and/or antibiotics, and/or serious history of serious adverse events through vaccination
结局指标
主要结局
number of febrile RTI-episodes
次要结局
- severity and length of febrile RTI-episodes as well as medical consumption