MMR and Varicella Vaccine Responses in Extremely Premature Infants
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 32
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to see if the MMR and chickenpox vaccines work as well in premature infants as in children that were carried to full term. A group of children who were carried full-term will be matched for age, sex, and race and will be used for comparison.
详细描述
The purpose of this study is to see if the MMR and chickenpox vaccines work as well in premature infants as in children that were carried to full term. A group of children who were carried full-term will be matched for age, sex, and race and will be used for comparison. Extremely premature infants (born at <28-30 weeks gestation) have lower antibody responses than full-term infants to several vaccines given at the postnatal ages recommended for full term infants. We propose to evaluate the immunogenicity of varicella and mumps-measles-rubella (MMR) vaccines in relatively healthy 15 month-old children born at <29 weeks gestation. This is a phase IV, observational study with 2 study arms having 16 infants each. The first group will enroll infants 9-12 months old that were born premature (<29 weeks gestation). The second group will be matched for sex, race, and postnatal age, but will have been full term (>= 37 weeks gestation) at birth. Infants will be vaccinated at visit 1 and post-vaccine serology will drawn at visit 2 (4 to 6 weeks after visit 1).
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 16 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.