Real-World Effectiveness of RSV Vaccines Among Adults Using Target Trial Emulation in Epic Cosmos
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Pfizer
- 入组人数
- 293,334
- 试验地点
- 1
- 主要终点
- Incidence of RSV-related Acute Respiratory Infection (ARI) hospitalization
研究概览
简要总结
Among non-pregnant adults observed in Epic Cosmos since August 2023 who are eligible for RSV vaccination, what is the effectiveness of ABRYSVO® (RSVpreF), compared with unvaccinated individuals, in preventing RSV-related and all-cause acute respiratory illness (ARI), lower respiratory tract disease (LRTD), and other outcomes of interest, within a target trial emulation (TTE) framework
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion: Vaccinated Cohort
- •Patients must meet all the following inclusion criteria to be eligible for inclusion in the vaccinated cohort:
- •Adults meet the age criteria at the index date. Non-pregnant at the index date. Have at least one clinical encounter recorded in Epic Cosmos database during the 12 months prior to the index date.
- •Have a documented administration of ABRYSVO® (or AREXVY®，mRESVIA® in the later phase) in Epic Cosmos on or after August
- •The index date for vaccinated individuals will be defined as the date of RSV vaccination.
- •Unvaccinated Cohort
- •Patients must meet all the following inclusion criteria to be eligible for inclusion in the unvaccinated cohort:
- •Adults meet the age criteria at the index date. Non-pregnant at the index date. Have at least one clinical encounter recorded in Epic Cosmos database during the 12 months prior to the index date.
- •Have no documented receipt of any RSV vaccine in Epic Cosmos on or prior to the trial start date.
- •The index date for unvaccinated individuals will be defined as the start date of each sequential trial (e.g., 1st date of each month) in which they met eligibility criteria.
- •Vaccinated Cohort
- •Patients meeting any of the following criteria will not be included in the vaccinated cohort:
- •Individual with receipt of any RSV vaccine in Epic Cosmos prior to the trial start date, as defined above (applicable to all analyses except for the analysis of recipients of multiple doses).
- •Non-US residents. Unvaccinated Cohort
- •Patients meeting any of the following criteria will not be included in the unvaccinated cohort:
- •Individual with receipt of any RSV vaccine in Epic Cosmos on or prior to the trial start date, as defined above.
- •Non-US residents. Patients must meet all the inclusion criteria and none of the
排除标准
- •to meet eligibility requirements.
研究组 & 干预措施
Vaccinated group
Individuals with documented receipt of an RSV vaccine in EHR data. Vaccines included: ABRYSVO® (Pfizer),AREXVY® (GSK), mRESVIA® (Moderna)
Unvaccinated comparator group:
Individuals not yet vaccinated at cohort entry, but otherwise eligible
结局指标
主要结局
Incidence of RSV-related Acute Respiratory Infection (ARI) hospitalization
时间窗: up to 3 years
Incidence of RSV-related Lower Respiratory Tract Disease (LRTD) hospitalization
时间窗: up to 3 years
次要结局
- Incidence of RSV-related outcomes(up to 3 years)
- Incidence of All-cause outcomes(up to 3 years)