Additional Measles Vaccine at 4 Months of Age
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
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.
研究概览
研究类型
阶段
- 第四阶段
联系人和位置
学习联系方式
- 姓名：Peter Aaby, DMSc
- 电话号码：+45 3268 3950
- 邮箱：p.aaby@bandim.org
研究联系人备份
- 姓名：Christine S Benn, MD, PhD
- 电话号码：+45 3268 8354
- 邮箱：cb@ssi.dk
学习地点
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Bissau、几内亚比绍、1004
- 招聘中
- Bandim Health Project
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首席研究员：
- Cesario L Martins, MD, PhD
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Children aged 4 to 7 months who received the third dose of pentavalent vaccine at least 4 weeks earlier
Exclusion Criteria:
- Malformations
- Severely ill
- Severely malnourished
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Early measles vaccine
Receives an early measles vaccine in addition to the standard measles vaccine at 9 months of age
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Edmonston-Zagreb measles vaccine
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无干预：No early measles vaccine
Receives only the standard measles vaccine at 9 months of age
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
|---|---|
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Mortality
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Differences in mortality rates between the intervention and control groups
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次要结果测量
结果测量 |
措施说明 |
|---|---|
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Morbidity
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Symptoms of infection
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Hospitalisations/consultations
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Visits to health center for consultation due to illness, hospitalisation
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Growth
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Weight, length, arm circumference
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Measles infection
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Measles infection assessed by medical doctor and/or verified by blood samples
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合作者和调查者
出版物和有用的链接
一般刊物
- Aaby P, Martins CL, Garly ML, Bale C, Andersen A, Rodrigues A, Ravn H, Lisse IM, Benn CS, Whittle HC. Non-specific effects of standard measles vaccine at 4.5 and 9 months of age on childhood mortality: randomised controlled trial. BMJ. 2010 Nov 30;341:c6495. doi: 10.1136/bmj.c6495.
- Nielsen S, Fisker AB, da Silva I, Byberg S, Biering-Sorensen S, Bale C, Barbosa A, Bjerregaard-Andersen M, Hansen NS, Do VA, Baek O, Rasmussen SM, Damkjaer L, Hvidt S, Baltzersen O, Rodrigues A, Martins C, Jensen KJ, Whittle HC, Smits G, van der Klis F, Aaby P, Benn CS. Effect of early two-dose measles vaccination on childhood mortality and modification by maternal measles antibody in Guinea-Bissau, West Africa: A single-centre open-label randomised controlled trial. EClinicalMedicine. 2022 May 27;49:101467. doi: 10.1016/j.eclinm.2022.101467. eCollection 2022 Jul.
- Hansen NS, Byberg S, Hervig Jacobsen L, Bjerregaard-Andersen M, Jensen AKG, Martins C, Aaby P, Skov Jensen J, Benn CS, Whittle H. Effect of early measles vaccine on pneumococcal colonization: A randomized trial from Guinea-Bissau. PLoS One. 2017 May 17;12(5):e0177547. doi: 10.1371/journal.pone.0177547. eCollection 2017. Erratum In: PLoS One. 2019 Oct 30;14(10):e0224782.
- Christensen LD, Eriksen HB, Biering-Sorensen S, Bale C, Do VA, Andersen A, Martins CL, Sodemann M, Aaby P, Benn CS. The effect of early measles vaccination on thymic size. A randomized study from Guinea-Bissau. Vaccine. 2014 Mar 26;32(15):1641-4. doi: 10.1016/j.vaccine.2014.01.034. Epub 2014 Feb 9.
有用的网址
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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