Influenza IMPRINT Cohort: Defining the Impact of Initial Influenza Exposure on Immunity in Infants
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Immune response to influenza virus infection
研究概览
简要总结
The primary aim is to define the immune responses to the infant's initial influenza exposure (vaccine or infection) and how that affects the immune response to subsequent influenza exposures
详细描述
Vaccination is a leading public health intervention for reducing morbidity and mortality from influenza worldwide. Vaccine optimization is hampered by lack of understanding the natural history of infection and immunity, including the full complement of maternal immunity imparted to infants. This gap in understanding can be addressed only through a well-designed birth cohort study. Up to 1500 mother-infant pairs will be enrolled at or after week 34 in pregnancy over three flu seasons, up to four years of age depending on birth month, at two sites. Follow-up will occur from the third trimester until the child is three to four years of age, along with medical records review to ascertain outcomes not captured through weekly illness and respiratory surveillance, and medical record review up to 18 years of age. The primary aim is to rigorously document the natural history of infection and immune response to influenza in study infants for at least three entire flu seasons.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Mother pregnant and ≥ 34 weeks gestation and ≥ 18 yrs. of age
- •Plans to deliver at local hospital
- •Lives within designated home zip codes:
- •No plans to move outside study area within study timeframe
- •Cell phone that can be used for text messaging
- •Singleton live born infant, born ≥ 34 weeks gestational age (GA)
排除标准
- •Fetal or infant death prior to maternal hospital discharge
- •Mother known to be infected with HIV based on medical records
- •Major congenital anomalies, prenatally diagnosed or other major disorder or anomaly as determined by the PI
- •Reported use of heroin, cocaine or methamphetamines during pregnancy
- •Adoptive infant
- •Enrolled in any investigational vaccine trial or other interventional randomized, clinical trial involving the mother or infant that the PI's deem to be in conflict with study outcomes
结局指标
主要结局
Immune response to influenza virus infection
时间窗: 4 years
Evaluate the immune response to influenza virus infections due to various subtypes in healthy children from birth to 4 years of age in a maternal-infant birth cohort
Immune response to influenza vaccination
时间窗: 4 years
Evaluate the immune response to influenza vaccination in healthy children from 6 months to 4 years of age in a maternal-infant birth cohort
次要结局
未报告次要终点