Safety Study of GSK Biologicals' Rotarix® (Rotavirus Vaccine, Live, Oral) Administered to a Birth Cohort in United States Health Insurance Plans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 390,659
- 试验地点
- 1
- 主要终点
- Incidence Rates of Intussusceptions (IS) Among the HRV Cohort and Comparator Cohorts
研究概览
简要总结
This observational cohort study, conducted through two existing large administrative health databases in the US (outside the Vaccine Safety Datalink) is planned to confirm the safety profile regarding lack of any association of intussusception with Rotarix within 60 days of vaccination in a real life setting (routine use) in the US. This study will also include monitoring of Kawasaki disease, convulsions, hospitalizations due to acute lower respiratory tract infections and all-cause deaths within 60-days of vaccination.
This study involves three cohorts, one exposed and two control cohorts: infants who receive Rotarix (Exposed cohort) and infants who receive IPV vaccination (Unexposed cohort A and B).
This is a combined prospective and retrospective cohort study. Prospective component of the study identifies and compares study outcomes following Rotarix and IPV vaccination in the Exposed cohort and Unexposed cohort A, respectively.
Retrospective component of the study identifies and compares study outcomes following IPV vaccination in the Unexposed cohort B.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- — 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For Exposed cohort:
- •Infants aged less than 1 year at study entry.
- •Infants who are enrolled in one of the two participating health insurance plans databases within 30 days of birth.
- •Have complete medical coverage and pharmacy benefits.
- •Received at least one dose of Rotarix from 1 August
- •Infants receiving Rotarix liquid formulation will also be eligible.
- •For Unexposed cohort A:
- •Infants aged less than 1 year at study entry.
- •Infants who are enrolled in one of the two participating health insurance plans databases within 30 days of birth.
- •Have complete medical coverage and pharmacy benefits.
- •Received at least one dose of IPV vaccine from 1 August 2008, with or without RotaTeq vaccination.
- •Frequency-matched to the Rotarix cohort by gender, age at first vaccination (±1 week) and calendar quarter of vaccination within the same year.
- •For Unexposed cohort B:
- •Infants who are enrolled in one of the two participating health insurance plans databases within 30 days of birth.
- •Had complete medical coverage and pharmacy benefits.
- •Received at least one dose of IPV vaccine.
- •Vaccinated between 1 January 2006 (inclusive) and 31 July 2008 (inclusive).
- •Not received any dose of rotavirus vaccination.
- •Frequency-matched to the Rotarix cohort by gender, age at first vaccination (±1 week) and calendar quarter of vaccination.
排除标准
- •For Exposed cohort:
- •Subject has received any dose of RotaTeq prior to the first Rotarix vaccine during the study period.
- •For Unexposed cohort A:
- •Subject has received any dose of Rotarix prior to the first IPV vaccine during the study period.
- •For Unexposed cohort B:
- •Subject has received any dose of rotavirus vaccines prior to the first IPV vaccine.
结局指标
主要结局
Incidence Rates of Intussusceptions (IS) Among the HRV Cohort and Comparator Cohorts
时间窗: 60 days following each vaccination
Incidence rates were calculated following the first 2 doses of study vaccine as the number of events divided by the sum of the person-time in that risk period. Person-time was defined as the number of days at risk for the study outcomes. Person-time was calculated in months by dividing the number of person-days by (365.25/12).
Incidence Rates of IS Among the HRV Cohort and Comparator Cohorts
时间窗: 30 days following each vaccination
Incidence rates were calculated following the first 2 doses of study vaccine as the number of events divided by the sum of the person-time in that risk period. Person-time was defined as the number of days at risk for the study outcomes. Person-time was calculated in months by dividing the number of person-days by (365.25/12).
次要结局
- Incidence Rates of Convulsions Among the HRV Cohort and Comparator Cohorts(60 days following each vaccination)
- Incidence Rates of Kawasaki Disease Among the HRV Cohort and Comparator Cohorts(60 days following each vaccination)
- Incidence Rates of Acute Lower Respiratory Tract Infection (LRTI) Hospitalisation Among the HRV Cohort and Comparator Cohorts(60 days following each vaccination)
- Incidence Rates of All-cause Mortality Among the HRV Cohort and Comparator Cohorts(60 days following each vaccination)
- Incidence Rates of Acute LTRI Hospitalisation Among the HRV Cohort and Comparator Cohorts(30 days following each vaccination)