NCT00995813已完成4 期
Pilot Study of the Safety and Immunogenicity of the Rotavirus Vaccine in Infants With Intestinal Failure
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- The safety of the rotavirus vaccine in infants with intestinal failure is the primary outcome variable.
研究概览
简要总结
The purpose of this study is to assess the safety and immune response of the rotavirus vaccine in infants who have undergone abdominal surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Weeks 至 14 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants with one of the following diagnoses:
- •necrotizing enterocolitis requiring operation;
- •congenital atresia of the intestine;
- •gastroschisis;
- •midgut volvulus requiring bowel resection; or
- •long-segment intestinal aganglionosis
- •Minimum gestational age of 35 weeks at time of first vaccine dose
排除标准
- •immunocompromise secondary to HIV infection or immunodeficiency state
- •active use of corticosteroid or other immunosuppressive agents
- •active infection as defined by fever > 38°C within 24 hours, positive blood culture within 7 days, or positive urine culture within 3 days of enrollment
- •severe malnutrition as defined by serum albumin < 2.0 mg/dL or serum prealbumin < 6 mg/dL.
结局指标
主要结局
The safety of the rotavirus vaccine in infants with intestinal failure is the primary outcome variable.
时间窗: 1-12 weeks following vaccine administration
次要结局
- The secondary outcome measure is the preliminary measurement of the immunogenicity of the rotavirus vaccine in infants with intestinal failure.(1-12 weeks following vaccine administration)
研究者
Patrick Javid
Principal Investigator
Seattle Children's Hospital
研究点 (2)
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