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.
Study Type
OBSERVATIONAL
Enrollment
350,399
PCV13 administration
Pfizer
New York, New York, United States
PCV13 Vaccine Effectiveness (VE) for First Event of Invasive Pneumococcal Disease (IPD): Overall Follow-up
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).
Time frame: 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 for First Event of IPD at 0-3 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).
Time frame: 0 to 3 years of follow up
VE for First Event of IPD at 3-5 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).
Time frame: 3 to 5 years of follow up
VE for First Event of IPD at 5-7 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).
Time frame: 5 to 7 years of follow up
PCV13 VE for First Event of Pneumococcal Pneumonia (PP): Overall 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).
Time frame: 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 for First Event of PP at 0-3 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).
Time frame: 0 to 3 years of follow up
VE for First Event of PP at 3-5 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).
Time frame: 3 to 5 years of follow up
VE for First Event of PP at 5-7 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).
Time frame: 5 to 7 years of follow up
PCV13 VE for First Event of All-cause Pneumonia (ACP): Overall 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).
Time frame: 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 for First Event of ACP at 0-3 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).
Time frame: 0 to 3 years of follow up
VE for First Event of ACP at 3-5 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).
Time frame: 3 to 5 years of follow up
VE for First Event of ACP at 5-7 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.
Time frame: 5 to 7 years of follow up
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
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. Data for total number of participants with episodes of pneumococcal pneumonia or pneumonia with unspecified causes are 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).
Time frame: 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
VE 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. Pneumonia with unspecified causes was identified based on ICD-9-CM or ICD-10-CM codes. Data for total number of participants with episodes of pneumonia with unspecified causes are 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).
Time frame: 0 to 3 years, 3 to 5 years and 5 to 7 years of follow-up (maximum up to 8.25 years)
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