Direct and Indirect Protection by Influenza Vaccine Given to Children in India
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 4,598
- 试验地点
- 1
- 主要终点
- Laboratory-confirmed influenza infection in vaccinated child
研究概览
简要总结
The study described here will immunize children with trivalent influenza vaccine (TIV) and determine whether this reduces influenza illness among the immunized children and their older family members. The comparison or control group for the children receiving influenza vaccine will be children immunized with inactivated poliovirus vaccine (IPV). The study will also provide information on the amount of disease produced by influenza in the study population.
详细描述
Influenza is an important cause of illness among children and adults in the United States. Influenza is likely also an important cause of illness in India, but published data on influenza infections in India are limited, especially for children. Although influenza vaccines are used routinely in the United States, including in young children, influenza vaccines have not seen widespread use in India. This is likely due to the lack of information from India about disease burden due to influenza and because the influenza vaccines have never been tested for efficacy in India. In addition, because young children are thought to be important in the spread of influenza in families, it is possible immunization of children against influenza will reduce influenza infections among older children and adults in the home.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion in either vaccine group (TIV or IPV) will require ages 6 months through 10 years of age.
- •All individuals in enrolled households will be eligible for enrollment into surveillance arm.
排除标准
- •Exclusion criteria from the vaccine groups includes known allergy to eggs, or hypersensitivity to other components of a vaccine (streptomycin, neomycin, and polymyxin B)
结局指标
主要结局
Laboratory-confirmed influenza infection in vaccinated child
时间窗: 1 year
次要结局
- Laboratory-confirmed influenza infection in household member of a vaccinated child(1 year)
研究者
Wayne Sullender, M.D.
Principal Investigator
University of Alabama at Birmingham