NCT01764269已完成不适用
Assessing Fever Rates in Children Ages 24 to 59 Months After Live Attenuated Influenza Vaccine (LAIV) or Inactivated Influenza Vaccines (IIV) Using Text Messaging for U.S. Influenza Vaccines in 2012-2013 & 2013-2014
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 656
- 试验地点
- 2
- 主要终点
- fever
研究概览
简要总结
In this study, the investigators will prospectively assess fever rates in 24-59 month old patients during days 0-10 after administration of inactivated influenza vaccine (IIV) or live attenuated influenza vaccine (LAIV). Children in one of three study sites who receive these vaccines as part of their routine care can enroll in this study if their parent has the ability to receive and send text messages. Children enrolled in this study will be observed for an eleven day period starting on the day of vaccine administration via a series text messages to their parents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 24 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •are 24 through 59 months of age,
- •have a visit at a study site anytime during the study period,
- •receive first dose LAIV or IIV in the season,
- •the parent has a cell phone with text messaging capabilities, and
- •the parent speaks English or Spanish.
- •Exclusion criteria:
- •any chronic medical condition in the child that precludes receipt of LAIV (except for history of asthma or a wheezing episode within the past 12 months noted in the medical record),
- •currently on oral or other systemic steroids or used in the past month,
- •currently on inhaled steroids or used in the past 2 weeks,
- •presence of fever >=100.4 at time of vaccination,
- •administration of any antipyretic in the 6-hour period prior to vaccination,
- •stated intent, at time of vaccination, to use prophylactic antipyretics before the development of a fever,
- •parent only speaks a language other than English or Spanish,
- •parent's inability to read text messages,
- •child receiving the second dose of influenza vaccine in the current season.
排除标准
- 未提供
结局指标
主要结局
fever
时间窗: 11 days
day of vaccination plus 10 more days
次要结局
未报告次要终点
研究者
Melissa Stockwell, MD, MPH
Assistant Professor of Pediatrics and Population and Family Health
Columbia University
研究点 (2)
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