NCT05040802已完成不适用
Effectiveness of Adacel Vaccination in Pregnancy at Preventing Pertussis in Infants < 2 Months of Age in the United States (US)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 462
- 试验地点
- 1
- 主要终点
- Number of pertussis cases in infants less than 2 months and matched controls
研究概览
简要总结
The purpose of this study is to determine the effectiveness of Adacel against pertussis disease in infants < 2 months when administered during pregnancy following the current Advisory Committee on Immunization Practices (ACIP) recommendations, i.e., from 27 to 36 weeks of gestation, and 14 days or more before delivery.
详细描述
The original study included cases recorded from 01 January 2011 through 31 December 2014, based on retrospective case-control methodology.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 2 Days 至 2 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cases were included if they met the following inclusion criteria:
- •Reported pertussis disease in the referenced EIP surveillance database
- •Age greater than 2 days and younger than two months of age
- •Resided in the catchment area on date of onset of their cough
- •Born in a hospital in their state of residence
- •≥ 37 weeks of gestation at birth
- •Not adopted, in foster care or living in a residential care facility
- •Completed maternal interview
- •Completed infant and maternal information
- •Controls were included if they met the following inclusion criteria:
- •Age greater than 2 days and younger than 2 months of age on date of cough onset for the corresponding case infant
- •Resided in the catchment area on date of cough onset for the corresponding case infant
- •Born in a hospital in their state of residence
- •≥ 37 weeks of gestation at birth
- •Not adopted, in foster care or living in a residential care facility
- •Maternal interview completed
- •Infant and maternal information complete
排除标准
- •Cases were excluded if they met any of the following exclusion criteria:
- •Vaccination status of the mother unknown
- •Infants whose mothers were vaccinated with Boostrix or an unknown vaccine brand
- •Controls were excluded if they met any of the following exclusion criteria:
- •Vaccination status of the mother unknown
- •A pertussis diagnosis prior to the cough onset date of the corresponding case infant
- •Controls that were matched to Boostrix or an unknown brand cases
结局指标
主要结局
Number of pertussis cases in infants less than 2 months and matched controls
时间窗: During the data collection period (from 01 January 2011 to 31 December 2014)
Vaccine effectiveness at preventing pertussis in infants less than 2 months of age was estimated using conditional logistic regression.
次要结局
- Number of pertussis cases requiring hospitalization in infants less than 2 months and matched controls(During the data collection period (from 01 January 2011 to 31 December 2014))
研究者
研究点 (1)
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