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临床试验/NCT01306006
NCT01306006已完成4 期

The Effect on Overall Mortality of a National Policy of Limiting Measles Vaccination to Children Below 12 Months of Age

Bandim Health Project1 个研究点 分布在 1 个国家目标入组 3,500 人开始时间: 2011年2月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
3,500
试验地点
1
主要终点
Mortality

研究概览

简要总结

The national Expanded Programme on Immunization (EPI) in Guinea-Bissau focuses its efforts exclusively on children below 12 months of age; children who have reached 12 months of age are no longer entitled to vaccines through the EPI program. This has affected the measles vaccination coverage, approx. 30% of the children in the rural area do not receive measles vaccine (MV).

Studies from the Bandim Health Project (BHP) have shown that MV has a profound impact on survival, reducing mortality by approximately 50% - far more than can be explained by prevention of measles deaths. Hence, MV seems to have non-specific beneficial effects on survival, and the current policy may have important consequences for overall child mortality.

To test the implications of the current policy of only vaccinating children below 12 months of age, the investigators will conduct a cluster randomized trial, in which children will receive their vaccines according to the current national EPI policy (National policy) or receive MV regardless of age and whether some doses of MV may be lost (MV-for-all policy).

The investigators hypothesise that among children enrolled after 12 months of age, mortality is 50% lower in children randomised to receive MV compared with children randomised to follow the national policy and not receive MV.

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
9 Months 至 35 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Age 9-35 months, not yet received routine measles vaccination, resident in study area

排除标准

  • To ill to be vaccinated (according to local practice)

研究组 & 干预措施

MV-for-all

Active Comparator

Measles vaccine provided to all children aged 9 months -3 years of age

干预措施: Providing measles vaccine for all children 9-35 months who have not yet received a routine measles vaccine (Biological)

National policy

No Intervention

Measles vaccine provided to children aged 9-11 months, if there are sufficient children to open a measles vaccine vial.

结局指标

主要结局

Mortality

次要结局

  • Hospital morbidity

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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