Assessment of 13-valent Pneumococcal Conjugate Vaccine Effectiveness Among People With HIV in the United States
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 350,399
- 试验地点
- 1
- 主要终点
- PCV13 Vaccine Effectiveness (VE) for First Event of Invasive Pneumococcal Disease (IPD): Overall Follow-up
研究概览
简要总结
The purpose of this study is to learn about how well a vaccine (Prevnar 13, PCV13) works in preventing disease in adults with HIV.
The diseases studied are pneumonia. Mostly the ones caused by the bacteria - pneumococcus. This study also evaluates the type of pneumonia that is spread into the bloodstream.
All participants in the study will be identified in health care databases. Adults with HIV will be identified by looking for a medical diagnosis that has confirmed HIV from the databases. Vaccination will be identified in the databases by looking for vaccine administration or for PCV13.
Participants will be followed in the databases to see if they have one of the diseases mentioned above or not. The number of vaccinated participants with the diseases will be compared to the number participants without the vaccines but with the diseases. This will help to understand how well the vaccine worked.
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
- •HIV infection defined as at least one inpatient or ≥2 outpatient codes related to HIV at least 30 days but no more than 730 days apart
- •At least 18 years of age at the time of the first HIV-related code
- •At least six months of continuous enrollment in medical and pharmacy plans after the first HIV-related code
排除标准
- •1. Evidence of PCV13 vaccination before the first HIV-related code
研究组 & 干预措施
Persons living with HIV (PLWH)
Adults with HIV
干预措施: Vaccine Administration (Biological)
结局指标
主要结局
PCV13 Vaccine Effectiveness (VE) for First Event of Invasive Pneumococcal Disease (IPD): Overall Follow-up
时间窗: From index date to the earliest of death, end of health plan enrollment or end of study period (maximum up to 8.25 years)
VE:\[(1-hazard ratio (HR)\]\*100 and was obtained from marginal structural Cox models(Cox-MSM) after applying Inverse probability of treatment (IPT)\*Inverse probability of censoring(IPC)weights.IPTW was generated from predicted probabilities of vaccination status (propensity scores) to create pseudo-populations where any imbalances in potential confounders by vaccination status were reduced. IPCW was used to adjust for informative censoring. IPD: based on International Classification of Diseases,9th revision, Clinical Modification(ICD-9-CM)or ICD-10-CM.Data for total number of participants with IPD is reported in descriptive and VE (IPTW\*IPCW+imbalanced variables) is reported in statistical section.PCV13 vaccination status was a time varying exposure (i.e.,vaccination status was not fixed at start of follow-up and participants could receive PCV13 during follow-up).
VE for First Event of IPD at 0-3 Years of Follow-up
时间窗: 0 to 3 years of follow up
VE: \[(1- hazard ratio (HR)\] \* 100 and was obtained from Cox-MSM after applying the IPT \*IPC weights. IPTW was generated from predicted probabilities of vaccination status (propensity scores) to create pseudo-populations where any imbalances in the potential confounders by vaccination status were reduced. IPCW was used to adjust for informative censoring. IPD was identified based on ICD-9-CM or ICD-10-CM codes. Data for total number of participants with episodes of IPD is reported in the descriptive section and data for vaccine effectiveness (IPTW\*IPCW + imbalanced variables) is reported in statistical analysis section. PCV13 vaccination status was a time varying exposure (i.e.,vaccination status was not fixed at start of follow-up and participants could receive PCV13 during follow-up).
VE for First Event of IPD at 3-5 Years of Follow-up
时间窗: 3 to 5 years of follow up
Vaccine effectiveness was calculated as \[(1- hazard ratio (HR)\] \* 100 and was obtained from Cox-MSM after applying the IPT \*IPC weights. IPTW was generated from predicted probabilities of vaccination status (propensity scores) to create pseudo-populations where any imbalances in the potential confounders by vaccination status were reduced. IPCW was used to adjust for informative censoring. IPD was identified based on ICD-9-CM or ICD-10-CM codes. Data for total number of participants with episodes of IPD is reported in the descriptive section and data for vaccine effectiveness (IPTW\*IPCW + imbalanced variables) is reported in statistical analysis section. PCV13 vaccination status was a time varying exposure (i.e.,vaccination status was not fixed at start of follow-up and participants could receive PCV13 during follow-up).
VE for First Event of IPD at 5-7 Years of Follow-up
时间窗: 5 to 7 years of follow up
Vaccine effectiveness was calculated as \[(1- hazard ratio (HR)\] \* 100 and was obtained from Cox-MSM after applying the IPT \*IPC weights. IPTW was generated from predicted probabilities of vaccination status (propensity scores) to create pseudo-populations where any imbalances in the potential confounders by vaccination status were reduced. IPCW was used to adjust for informative censoring. IPD was identified based on ICD-9-CM or ICD-10-CM codes. Data for total number of participants with episodes of IPD is reported in the descriptive section and data for vaccine effectiveness (IPTW\*IPCW + imbalanced variables) is reported in statistical analysis section. PCV13 vaccination status was a time varying exposure (i.e.,vaccination status was not fixed at start of follow-up and participants could receive PCV13 during follow-up).
PCV13 VE for First Event of Pneumococcal Pneumonia (PP): Overall Follow-up
时间窗: From index date to the earliest of death, end of health plan enrollment or end of study period (maximum up to 8.25 years)
Vaccine effectiveness was calculated as \[(1- hazard ratio (HR)\] \* 100 and was obtained from Cox-MSM after applying the IPT \*IPC weights. IPTW was generated from predicted probabilities of vaccination status (propensity scores) to create pseudo-populations where any imbalances in the potential confounders by vaccination status were reduced. IPCW was used to adjust for informative censoring. PP was identified based on ICD-9-CM or ICD-10-CM codes. Data for total number of participants with episodes of PP is reported in the descriptive section and data for vaccine effectiveness (IPTW\*IPCW + imbalanced variables) is reported in statistical analysis section. PCV13 vaccination status was a time varying exposure (i.e.,vaccination status was not fixed at start of follow-up and participants could receive PCV13 during follow-up).
VE for First Event of PP at 0-3 Years of Follow-up
时间窗: 0 to 3 years of follow up
Vaccine effectiveness was calculated as \[(1- hazard ratio (HR)\] \* 100 and was obtained from Cox-MSM after applying the IPT \*IPC weights. IPTW was generated from predicted probabilities of vaccination status (propensity scores) to create pseudo-populations where any imbalances in the potential confounders by vaccination status were reduced. IPCW was used to adjust for informative censoring. PP was identified based on ICD-9-CM or ICD-10-CM codes. Data for total number of participants with episodes of PP is reported in the descriptive section data for vaccine effectiveness (IPTW\*IPCW + imbalanced variables) is reported in statistical analysis section. PCV13 vaccination status was a time varying exposure (i.e.,vaccination status was not fixed at start of follow-up and participants could receive PCV13 during follow-up).
VE for First Event of PP at 3-5 Years of Follow-up
时间窗: 3 to 5 years of follow up
Vaccine effectiveness was calculated as \[(1- hazard ratio (HR)\] \* 100 and was obtained from Cox-MSM after applying the IPT \*IPC weights. IPTW was generated from predicted probabilities of vaccination status (propensity scores) to create pseudo-populations where any imbalances in the potential confounders by vaccination status were reduced. IPCW was used to adjust for informative censoring. PP was identified based on ICD-9-CM or ICD-10-CM codes. Data for total number of participants with episodes of PP is reported in the descriptive section and data for vaccine effectiveness (IPTW\*IPCW + imbalanced variables) is reported in statistical analysis section. PCV13 vaccination status was a time varying exposure (i.e.,vaccination status was not fixed at start of follow-up and participants could receive PCV13 during follow-up).
VE for First Event of PP at 5-7 Years of Follow-up
时间窗: 5 to 7 years of follow up
Vaccine effectiveness was calculated as \[(1- hazard ratio (HR)\] \* 100 and was obtained from Cox-MSM after applying the IPT \*IPC weights. IPTW was generated from predicted probabilities of vaccination status (propensity scores) to create pseudo-populations where any imbalances in the potential confounders by vaccination status were reduced. IPCW was used to adjust for informative censoring. PP was identified based on ICD-9-CM or ICD-10-CM codes. Data for total number of participants with episodes of PP is reported in the descriptive section and data for vaccine effectiveness (IPTW\*IPCW + imbalanced variables) is reported in statistical analysis section. PCV13 vaccination status was a time varying exposure (i.e.,vaccination status was not fixed at start of follow-up and participants could receive PCV13 during follow-up).
PCV13 VE for First Event of All-cause Pneumonia (ACP): Overall Follow-up
时间窗: From index date to the earliest of death, end of health plan enrollment or end of study period (maximum up to 8.25 years)
Vaccine effectiveness was calculated as \[(1- hazard ratio (HR)\] \* 100 and was obtained from Cox-MSM after applying the IPT \*IPC weights. IPTW was generated from predicted probabilities of vaccination status (propensity scores) to create pseudo-populations where any imbalances in the potential confounders by vaccination status were reduced. IPCW was used to adjust for informative censoring. ACP was identified based on ICD-9-CM or ICD-10-CM codes. Data for total number of participants with episodes of ACP is reported in the descriptive section and data for vaccine effectiveness (IPTW\*IPCW + imbalanced variables) is reported in statistical analysis section. PCV13 vaccination status was a time varying exposure (i.e.,vaccination status was not fixed at start of follow-up and participants could receive PCV13 during follow-up).
VE for First Event of ACP at 0-3 Years of Follow-up
时间窗: 0 to 3 years of follow up
Vaccine effectiveness was calculated as \[(1- hazard ratio (HR)\] \* 100 and was obtained from Cox-MSM after applying the IPT \*IPC weights. IPTW was generated from predicted probabilities of vaccination status (propensity scores) to create pseudo-populations where any imbalances in the potential confounders by vaccination status were reduced. IPCW was used to adjust for informative censoring. ACP was identified based on ICD-9-CM or ICD-10-CM codes. Data for total number of participants with episodes of ACP is reported in the descriptive section and data for vaccine effectiveness (IPTW\*IPCW + imbalanced variables) is reported in statistical analysis section. PCV13 vaccination status was a time varying exposure (i.e.,vaccination status was not fixed at start of follow-up and participants could receive PCV13 during follow-up).
VE for First Event of ACP at 3-5 Years of Follow-up
时间窗: 3 to 5 years of follow up
Vaccine effectiveness was calculated as \[(1- hazard ratio (HR)\] \* 100 and was obtained from Cox-MSM after applying the IPT \*IPC weights. IPTW was generated from predicted probabilities of vaccination status (propensity scores) to create pseudo-populations where any imbalances in the potential confounders by vaccination status were reduced. IPCW was used to adjust for informative censoring. ACP was identified based on ICD-9-CM or ICD-10-CM codes. Data for total number of participants with episodes of ACP is reported in the descriptive section and data for vaccine effectiveness (IPTW\*IPCW + imbalanced variables) is reported in statistical analysis section. PCV13 vaccination status was a time varying exposure (i.e.,vaccination status was not fixed at start of follow-up and participants could receive PCV13 during follow-up).
VE for First Event of ACP at 5-7 Years of Follow-up
时间窗: 5 to 7 years of follow up
Vaccine effectiveness was calculated as \[(1- hazard ratio (HR)\] \* 100 and was obtained from Cox-MSM after applying the IPT \*IPC weights. IPTW was generated from predicted probabilities of vaccination status (propensity scores) to create pseudo-populations where any imbalances in the potential confounders by vaccination status were reduced. IPCW was used to adjust for informative censoring. ACP was identified based on ICD-9-CM or ICD-10-CM codes. Data for total number of participants with episodes of ACP is reported in the descriptive section and data for vaccine effectiveness (IPTW\*IPCW + imbalanced variables) is reported in statistical analysis section. PCV13 vaccination status was a time varying exposure (i.e.,vaccination status was not fixed at start of follow-up and participants could receive PCV13 during follow-up.
次要结局
- PCV13 VE for First Event of Pneumococcal Pneumonia or Pneumonia With Unspecified Causes at 0-3, 3-5, 5-7 and Overall Years of Follow-up(0 to 3 years, 3 to 5 years and 5 to 7 years of follow-up (maximum up to 8.25 years))
- PCV13 VE for First Event of Pneumonia With Unspecified Causes at 0-3, 3-5, 5-7 and Overall Years of Follow-up(0 to 3 years, 3 to 5 years and 5 to 7 years of follow-up (maximum up to 8.25 years))