跳至主要内容
临床试验/NCT02252029
NCT02252029已完成不适用

RotaNeo: Evaluation of Rotavirus Vaccine Administration in Premature Babies in the Neonatal Unit

University of Oxford2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2014年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Number of days rotavirus vaccine can be detected in stool following immunisation

研究概览

简要总结

This study will establish the duration of excretion of rotavirus vaccine in stool following vaccination of premature babies hospitalised in a neonatal unit at the time of vaccination.

详细描述

Rotavirus is the commonest cause of severe gastroenteritis in young children, and premature babies are at high risk of serious disease. The RV1 rotavirus vaccine is an altered form of the virus and is given to all children at 8 weeks and 12 weeks of age in the UK. It is given by mouth and excreted in the stool following vaccination - the vaccine virus can therefore be transmitted between people in the same way as the normal virus. Premature babies often receive their initial vaccines while they are still hospitalised in neonatal units. There are no data regarding stool excretion of the RV1 rotavirus vaccine in premature babies - there is a theoretical risk of transmission of the vaccine virus to other babies in the unit (if there was inadequate staff hand washing). Some countries have therefore advised against immunisation of babies while in the neonatal unit. In the UK, however, the vaccine is being given in neonatal units, enabling evaluation of the vaccine in hospitalised premature babies.

This is an observational study of babies admitted to the neonatal unit at the John Radcliffe Hospital, Oxford University Hospitals NHS Trust who receive their first dose of rotavirus vaccine during their hospital stay.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
8 Weeks 至 15 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Participant's parent is willing and able to give informed consent for participation in the study.
  • Current inpatient in the neonatal unit and expected to remain an inpatient for at least 14 days following immunisation with rotavirus vaccine.
  • Due to receive rotavirus vaccination during their admission.
  • Born at less than 37 completed weeks gestation (i.e. up to and including 36 weeks and 6 days)

排除标准

  • Parent is listed on the study delegation log.

结局指标

主要结局

Number of days rotavirus vaccine can be detected in stool following immunisation

时间窗: 24 months

次要结局

  • Measurement of serum and stool antibody to rotavirus vaccine following vaccination(24 months)
  • Number of adverse events following rotavirus vaccine(12 months)
  • Comparison of vaccine responses after categorisation based on GI microbiome

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验