Effectiveness Assessment of Vaccinating Schoolchildren Against Influenza the in São Paulo, 2009
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,742
- 试验地点
- 2
- 主要终点
- Laboratory confirmed influenza
研究概览
简要总结
Vaccinating schoolchildren against influenza would prevent the disease among non-vaccinated household members.
详细描述
Children and adolescents play an important role in sustaining the transmission of influenza. Moreover, with the occurrence of influenza in children, there are important socioeconomic consequences to families affected by the disease, related to absenteeism, expenditure on health services and medication use. This study presents an evaluation of direct and indirect effectiveness of influenza vaccination in school age children and their unvaccinated household contacts. It was conducted in 2009, in Sao Paulo - Brazil, through a randomized double-blind community trial, with six months of follow up. For the evaluation of vaccine effectiveness, the influenza vaccine was used for the experimental group, and meningitis conjugate and varicella vaccines for the control group. After vaccination, the volunteers and their families were followed for six months, in order to identify cases of acute respiratory infection (ARI) and to collect biological samples for testing with RT-PCR for diagnosis of influenza.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •older than six years of age;
- •live in the study area;
- •parent consent to participate, by signing the Informed Consent Form;
- •no history of anaphilaxis or hipersensitivity to eggs or eggs proteins;
- •no history no history anaphilaxis or hipersensitivity to any substances;
- •no acute disease at the moment of vaccination
- •no use of immunesupressant drugs;
- •not have received any other vaccine in the previous six months;
- •no participation in other clinical trial in the previous six months.
排除标准
- •Any condition above mentioned.
结局指标
主要结局
Laboratory confirmed influenza
时间窗: June 01, 2009 to November 30, 2009
RT-PCR confirmed influenza in respiratory secretions samples
次要结局
- Acute Repiratory Infection (ARI)(6 months)