Health Effects of Utilising Curative Health System Contacts to Provide Measles Vaccination - a Randomised Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 入组人数
- 5,400
- 试验地点
- 1
- 主要终点
- Non-accident mortality or admission (Composite outcome)
研究概览
简要总结
In addition to protecting against measles infection, measles vaccine (MV) strengthens the individual's ability to combat infections in general - MV has beneficial non-specific effects (NSE) lowering the risk of death and admissions by around 30%.
In Guinea-Bissau 30% of children do not receive a routine MV scheduled at 9 months of age, putting both the individual child's health and measles eradication at risk. The coverage of a second dose of MV, which was added to the Bissau-Guinean vaccination programme in 2022, is even lower. WHO recommends vaccination at health system contacts, including those for curative services. At the paediatric ward of the national hospital in Guinea-Bissau, there are more than 2600 yearly contacts with measles-un or under-vaccinated children aged 9-59 months, but no vaccines are given. In a randomised controlled trial, we will assess the effect of providing MV vs placebo to 5400 children at hospital contacts (at discharge or after an out-patient consultation) to test the hypothesis that MV reduces the risk of admission or death (composite outcome) by 25% over the subsequent 6 months.
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
- 年龄范围
- 9 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Measles-unvaccinated children
- •9-59 months with a hospital contact (discharged or outpatient consultation) at the paediatric ward at the national hospital Simao Mendes.
- •Measles-under-vaccinated children (received first but not second dose of MV)
- •15-59 months with a hospital contact (discharged or outpatient consultation) at the paediatric ward at the national hospital Simao Mendes.
排除标准
- •Axil temperature >38.0
- •Mid upper arm circumference <110 mm
研究组 & 干预措施
Intervention
Standard dose measles vaccine, 0.5 ml
干预措施: measles vaccine (Biological)
Control
Saline injection, 0.5 ml
干预措施: Saline (Other)
结局指标
主要结局
Non-accident mortality or admission (Composite outcome)
时间窗: 6 months
Composite outcome of non-accidental death (recorded through telephone interviews and passive case detection) or an identified non-accidental hospital admission at the national hospital Simao Mendes
次要结局
- Cause specific hospital admissions at the national hospital.(6 months)
- Non-accidental mortality(6 and 12 months)
- Non-accidental hospital admission with an overnight stay in any health facility(6 months)