Diphtheria, Tetanus, Poliomyelitis -Pertussis-Hib Immunisation in Preterm-born Neonates (VacciPrema)
Comparison of Two Vaccinal Schemes for DTP-Pertussis-Hib Primo-immunisation in Very Preterm-born Neonates: a Randomised Bicentric Controlled Study
Preterm neonates are fragile to infections. Their immune system is immature, yet in France, primary vaccines are injected at two months of age, as in term infants.
Recommendations for vaccinations in infants have changed in France in 2013, suppressing the second injection at three months after birth. Preterm and full-term born infants are now vaccinated at two and four months of age, but no data regarding efficacy in very preterm infants have been registered.
The investigators hypothesize that two vaccine injections (at two and four months) would be less efficient than three injections (two, three and four months) in very preterm-born infants.
研究概览
地位
条件
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Nancy、法国、54000
- Centre Hospitalier Regional et Universitaire, Maternite Regionale
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Thionville、法国、57100
- Centre Hospitalier de Thionville
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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:
- infants born < 33 weeks gestation in Nancy and Thionville Maternity Wards
- signed parental consent
Exclusion Criteria:
- immunodeficiency
- vaccine contra-indication
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
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Three vaccine injections
Infants in this study arm will receive three vaccine injections at two, three and four months after birth (vaccine: DTP-pertussis-Hib).
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DTP-pertussis-Hib injections at two, three, four months after birth
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实验性的：Two vaccine injections
Infants in this study arm will receive two vaccine injections at two and four months after birth (vaccine: DTP-pertussis-Hib).
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DTP-pertussis-Hib injections are administered at two and four months after birth
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Hib antibody dosage in blood sample
大体时间：5 months after birth
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5 months after birth
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Pertussis antibody dosage in blood sample
大体时间：5 months after birth
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5 months after birth
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (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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