NCT06199934已完成不适用
Effectiveness of BNT162b2 Formulations Using State Vaccine Registry and Insurance Claims Data
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 19,853,610
- 试验地点
- 1
- 主要终点
- Number of Participants COVID-19 Diagnosis
研究概览
简要总结
The primary purpose of this study is to learn about how well different versions of the Pfizer-BioNTech COVID-19 vaccine (called BNT162b2) work at preventing death, severe COVID-19 that requires a trip to the hospital, and overall use of healthcare resources, such as needing to go the doctor or urgent care due to illness. Pfizer is not enrolling any participants for this study. Instead, existing data from different health data sources will be used to help answer the scientific questions Pfizer is interested in learning more about.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •People with at least one year of pharmacy and medical enrollment in HealthVerity prior to vaccine availability
- •State of California or Louisiana resident for at least one year
- •Exclusion criteria:
- •People currently pregnant,
- •Individuals with discrepancies in sex and/or year of birth between HealthVerity claims and California/Louisiana immunization registry datasets
- •A diagnosis of COVID-19 in any setting ≤ 90 days prior to start of study or receipt COVID-19 vaccine ≤ 90 days prior to start of study.
排除标准
- 未提供
研究组 & 干预措施
Vaccinated
BNT162b2 recipients
干预措施: Vaccination (Biological)
结局指标
主要结局
Number of Participants COVID-19 Diagnosis
时间窗: From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months)
Number of participants diagnosed with COVID-19 were reported in this outcome measure.
次要结局
- All-cause Healthcare Resource Utilization as The Total Number of Encounters, Regardless of Setting, Using Data From Administrative Healthcare Claims Dataset(From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months))
- Number of Participants With COVID-19-Related Hospitalization(From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months))
- Number of Participants With Non-COVID-19 Respiratory Infection(From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months))
- Number of Participants With Negative Control Outcomes(From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months))
- Total Costs of All-cause Hospitalizations From Administrative Healthcare Claims Dataset(From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months))
- Average Length of Stay (LOS)(From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months))
- Number of Participants With ICU Admission Are Included in This Outcome Measure.(From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months))
- Number of Participants Who Received High-flow Oxygen or Mechanical Ventilation (MV)(From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months))
- Number of Participants With Inpatient Mortality(From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months))
- Number of Participants With an Outpatient Encounter(From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months))
- Number of Participants With an Inpatient Encounter(From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months))
- Number of Participants Who Received Antiviral Treatment(From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months))
- Number of Participants With Emergency Department Encounter(From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months))
- Mean Cost of All-cause Healthcare From Administrative Healthcare Claims Dataset(From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months))
- Number of Participants With COVID-19 Critical Illness(From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months))
研究者
研究点 (1)
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