Comparison of Two Vaccinal Schemes for DTP-Pertussis-Hib Primo-immunisation in Very Preterm-born Neonates: a Randomised Bicentric Controlled Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 160
- 试验地点
- 4
- 主要终点
- Hib antibody dosage in blood sample
研究概览
简要总结
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
- — 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •infants born < 33 weeks gestation in Nancy and Thionville Maternity Wards
- •signed parental consent
排除标准
- •immunodeficiency
- •vaccine contra-indication
结局指标
主要结局
Hib antibody dosage in blood sample
时间窗: 5 months after birth
次要结局
- Pertussis antibody dosage in blood sample(5 months after birth)
研究者
Pr Rachel VIEUX
Professor Rachel Vieux
Central Hospital, Nancy, France