Boosting the Beneficial Non-specific Effects of Live Attenuated Vaccines: A Randomized Controlled Trial (RCT) of a Second Dose of Measles Vaccine (MV) in the Second Year of Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,812
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
This study evaluates the non-specific effects on child mortality and morbidity of a second dose of measles in the second year of life. Half of the study participants will receive a second dose of measles vaccine at 18 months of age while the other half will receive a second dose of measles by 4 years of age or at the end of the study.
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
- 18 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children need to have received the third dose of inactivated vaccines (Penta, PCV13 and IPV) before measles vaccination.
排除标准
- •Having severe malformations that impairs their health
- •Having received a second dose of measles vaccine
- •Severely ill (requiring hospitalization) upon clinical examination
结局指标
主要结局
Mortality
时间窗: 30 months
Mortality registered monthly by Health and Demographic Surveillance System fieldworkers. Mortality will be combined with hospital admissions in the analysis to form the outcome severe morbidity. This will be examined overall and by sex
Hospital admissions
时间窗: 30 months
Hospital admissions registered daily at the national hospital. Hospital admissions will be combined with mortality in the analysis to form the outcome severe morbidity. This will be examined overall and by sex
次要结局
- Hospital admission by cause(30 months)
- Consultations(30 months)