NCT01496079已完成不适用
The Role of Immunizing Pregnant Women In Protecting Young Infants Against Influenza
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 166
- 试验地点
- 1
- 主要终点
- Influenza antibody titer levels in infants born to women who receive inactivated influenza vaccine in early pregnancy compared with late pregnancy and no immunization
研究概览
简要总结
Study objectives are to compare
- influenza antibody levels in infant sera and maternal colostrum or breast milk at delivery, 2, and 6 months women who receive influenza immunization in early pregnancy, late pregnancy, or no influenza immunization during pregnancy and their infants
Study hypotheses are that infants born to pregnant women who receive influenza immunization in late pregnancy will have
- higher levels and a longer serum influenza antibody duration in sera (hemagglutination inhibition (HAI) titers) and colostrum/breast milk (influenza-specific IgA and IgG by enzyme-linked immunosorbent assay (ELISA) than infants of women immunized in early pregnancy or not immunized
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
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women 18-45 years of age from 8-36 weeks gestation in good health as determined by medical history and recent physical exam who
- •receive prenatal care at the UUHS Obstetrics and Gynecology Clinics and their infants
- •plan to seek care for their infant at the UUHS affiliated Pediatric Clinics (UUHS or SMC Pediatric Clinics)
- •plan for their infant to receive influenza immunization at 6 and 7 months of age
排除标准
- •maternal history of either a congenital or acquired immunodeficiency including infection (e.g. HIV), chronic steroid use, or malignancy
- •serious underlying neurological, cardiac, renal, or pulmonary disease in either the mother or infant
- •multiple gestation
- •antenatal or postnatal detection at delivery of any major birth defect in the infant
- •delivery of the infant before 37 weeks
结局指标
主要结局
Influenza antibody titer levels in infants born to women who receive inactivated influenza vaccine in early pregnancy compared with late pregnancy and no immunization
时间窗: Infant antibody titers at delivery
Influenza titers will be measured on infant serum and breast milk samples by HAI assay and on maternal colostrum or breast milk if available by ELISA and neutralization assay
次要结局
未报告次要终点
研究者
Julie Shakib
Assistant Professor of Pediatrics, Principal Investigator
University of Utah
研究点 (1)
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