A Randomised Trial of an Additional Measles Vaccine at 4 Months of Age to Reduce Child Mortality and to Explore the Role of Maternal Measles Antibodies for the Beneficial Non-specific Effects of Measles Vaccine
试验速览
- 阶段
- 4 期
- 试验地点
- 2
- 主要终点
- Mortality
研究概览
简要总结
Overall objective: To conduct a randomised controlled trial (RCT) to examine whether an early two-dose measles vaccination (MV) strategy at 4 and 9 months will reduce child mortality compared with the WHO strategy of one dose of MV at 9 months.
Specific hypotheses Hypothesis I) Two doses of MV at 4 and 9 months compared with the standard dose of MV at 9 months will reduce mortality by 30% between 4 months and 5 years of age1. As in a previous trial it is expected that the beneficial effect is strongest for girls.
Hypothesis II) Children receiving MV at 4 months in the presence of maternal measles antibodies (MatAb) will have 35% lower mortality between 4 months and 5 years of age than children receiving MV at 4 months with no detectable MatAb.
Implications: These hypotheses are based on a previous RCT showing strong beneficial effects of providing an early measles vaccine, in particular among children with MatAb.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Prevention
入排标准
- 年龄范围
- 4 Months 至 7 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 4 to 7 months who received the third dose of pentavalent vaccine at least 4 weeks earlier
排除标准
- •Malformations
- •Severely ill
- •Severely malnourished
结局指标
主要结局
Mortality
Differences in mortality rates between the intervention and control groups
次要结局
- Morbidity
- Hospitalisations/consultations
- Growth
- Measles infection