Effectiveness of Maternal Immunization With Boostrix at Preventing Pertussis Among Infants <2 Months Old in the United States: Analysis of a Dataset From a Case-control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 290
- 试验地点
- 1
- 主要终点
- Number of Pertussis Cases and Matched Controls Among Infants Born to Mothers Vaccinated With Boostrix Vaccine (During Third Trimester of Pregnancy) or Not Exposed to Any Tdap Vaccine During Pregnancy
研究概览
简要总结
The purpose of this study is to estimate the effectiveness of maternal immunization with Boostrix at preventing pertussis in infants in the United States.
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
- •Inclusion criteria for case infants:
- •Case infants were eligible for the enrolment if they:
- •were at least 2 days old and < 2 months old on the cough onset date
- •resided in the catchment area on their cough onset date
- •were born in a hospital in their state of residence
- •were ≥37 weeks' gestational age at birth
- •were neither adopted nor in foster care
- •did not live in a residential care facility
- •Inclusion criteria for control infants:
- •Control infants were eligible for the enrolment if they:
- •were at least 2 days old and <2 months old on the case infant's cough onset date
- •were born in a hospital in their state of residence
- •were ≥37 weeks' gestational age at birth
- •were neither adopted nor in foster care
- •did not live in a residential care facility
- •were born at the same hospital as the case infant
- •did not have pertussis diagnosis prior to the cough onset date of the corresponding case infant
排除标准
- •Infants (case and controls) whose mothers have received Adacel or mothers without brand information available, as well as controls who were matched to a case whose mother received Adacel or mothers without brand information available, will be excluded from the analysis of the effectiveness of vaccination with Boostrix.
结局指标
主要结局
Number of Pertussis Cases and Matched Controls Among Infants Born to Mothers Vaccinated With Boostrix Vaccine (During Third Trimester of Pregnancy) or Not Exposed to Any Tdap Vaccine During Pregnancy
时间窗: During the data collection period (from 1 January 2011 to 31 December 2014)
Vaccine effectiveness at preventing pertussis occurrence in infants \< 2 months old is assessed by comparing the Boostrix immunization status during the third pregnancy trimester in mothers of infant pertussis cases and matched controls. The association between maternal Boostrix vaccination and pertussis in infants was analyzed using conditional logistic regression. The multivariate analysis was performed to obtain the adjusted values. Covariates that were statistically significant in the univariate analysis or considered as clinically significant were included in the multivariable conditional logistic regression model. Subjects with missing or unknown values, if any, for at least one of the risk factors were excluded from the model.
次要结局
- Number of Pertussis Cases Leading to Hospitalization and Matched Controls in Infants Born to Mothers Vaccinated With Boostrix (Before Pregnancy, During First or Second, Third Trimester, After Pregnancy) or Not Exposed to Any Tdap Vaccine During Pregnancy(During the data collection period (from 1 January 2011 to 31 December 2014))
- Number of Pertussis Cases and Matched Controls Among Infants Born to Mothers Vaccinated With Boostrix Vaccine (Before Pregnancy, During First or Second Trimester, After Pregnancy) or Not Exposed to Any Tdap Vaccine During Pregnancy(During the data collection period (from 1 January 2011 to 31 December 2014))
- Number of Pertussis Cases and Matched Controls Among Infants Born to Mothers Vaccinated With Boostrix Vaccine (During First, Second or Third Trimester) or Not Exposed to Any Tdap Vaccine During Pregnancy(During the data collection period (from 1 January 2011 to 31 December 2014))