MMR and Varicella Vaccine Responses in Extremely Premature Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
研究概览
简要总结
This research is designed to address the question, "Does the relative deficit in vaccine immunogenicity in extremely premature infants persist beyond the first 6 months of life?" We propose to measure the immunogenicity of varicella and mumps-measles-rubella vaccines in relatively healthy, 12-to-15 month-old children born at <29 weeks gestation, when compared to full-term infants, as measured by the relevant viral serologies.
详细描述
Title: MMR and Varicella Vaccine Responses in Extremely Premature Infants
Phase: IV
Population: 16 generally healthy premature infants born at < 29 weeks' gestation, < 16 months old from the Rochester area 16 generally healthy full-term infants born at >/= 37 weeks' gestation, < 16 months old from the Rochester area
Number of Sites: University of Rochester
Study Duration: 1.5 - 8.5 months
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Months 至 16 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must meet all of the inclusion criteria to participate in this study.
- •Premature infant < 29 weeks' gestation at birth or term infant >/= 37 weeks' gestation at birth.
- •Postnatal age < 16 months, 0 days.
- •Has not yet received MMR or varicella vaccines. (There are no restrictions on the administration of other vaccines at the time of MMR/varicella vaccination.)
- •Parental permission.
- •Agreement of primary care pediatrician/ health care provider.
- •Receives primary pediatric care within an approximate 25-mile radius of the University of Rochester.
- •Healthy status at enrollment.
排除标准
- •Known immunodeficiency.
- •Systemic corticosteroid therapy at the time of MMR/varicella vaccination.
- •Requiring oxygen therapy.
- •Clinically significant findings on review of medical history and physical exam determined by the investigator or sub-investigator to be sufficient for exclusion.
- •Any condition determined by the investigator that would interfere with the evaluation of the vaccine or be a potential health risk to the subject.
研究者
Carl D'Angio
Professor
University of Rochester