HIV, Infections, Pneumococcal, Pneumonia
Conditions
Brief summary
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.
Interventions
BIOLOGICALVaccine Administration
PCV13 administration
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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 2. At least 18 years of age at the time of the first HIV-related code 3. At least six months of continuous enrollment in medical and pharmacy plans after the first HIV-related code
Exclusion criteria
1\. Evidence of PCV13 vaccination before the first HIV-related code
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VE for First Event of ACP at 5-7 Years of Follow-up | 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. |
| VE for First Event of ACP at 0-3 Years of Follow-up | 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 | 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). |
| PCV13 Vaccine Effectiveness (VE) for First Event of Invasive Pneumococcal Disease (IPD): Overall Follow-up | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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). |
| 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) | 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). |
Countries
United States
Participant flow
Recruitment details
Data was collected from participants living with human immunodeficiency virus (PLWH) having an HIV diagnosis code between January 1, 2014 and December 31, 2021. Data was analyzed over 73 weeks in this retrospective study from March 22, 2023 to August 15, 2024.
Pre-assignment details
A total of 350399 participants were enrolled in the study. The six months of continuous enrollment in medical and pharmacy plans between 01-Jan-2014 and 31-Dec-2021 was considered the baseline period. The end of the study occurred on the last date that administrative claims data were available on September 30, 2022. Participants were followed up from index date to the earliest of death, end of health plan enrollment or end of study period (maximum up to 8.25 years).
Participants by arm
| Arm | Count |
|---|---|
| PCV13-vaccinated Participants Participants with an HIV diagnosis code who received PCV13 were included. The participants were followed up in the databases from 14 days after their PCV13 or index date if vaccinated during the baseline period, until the earliest occurrence of outcome, death, end of health plan enrollment, or end of study period. | 29,435 |
| Unvaccinated Participants Participants with an HIV diagnosis code who did not receive PCV13 were included. The participants were followed in the databases from index date until the earliest occurrence of PCV13 vaccination, death, end of health plan enrollment or end of study period. | 320,964 |
| Total | 350,399 |
Baseline characteristics
| Characteristic | Unvaccinated Participants | Total | PCV13-vaccinated Participants |
|---|---|---|---|
| Age, Customized 18-49 Years | 189050 Participants | 209621 Participants | 20571 Participants |
| Age, Customized 50-64 Years | 113632 Participants | 121539 Participants | 7907 Participants |
| Age, Customized 65-74 Years | 14617 Participants | 15431 Participants | 814 Participants |
| Age, Customized 75 Years or above | 3665 Participants | 3808 Participants | 143 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Sex/Gender, Customized Female | 99319 Participants | 106018 Participants | 6699 Participants |
| Sex/Gender, Customized Male | 221640 Participants | 244376 Participants | 22736 Participants |
| Sex/Gender, Customized Unknown | 5 Participants | 5 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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)
Population: PCV13 vaccination status was a time varying exposure and participants could be counted in both PCV13 vaccinated or unvaccinated arms, depending on vaccination status during follow-up. Here, 'Overall Number of Participants Analyzed (N)' for Unvaccinated arm=participants unvaccinated at start of study evaluable for this outcome measure (OM); N for vaccinated arm=participants vaccinated by end of follow up for this OM; hence, N is different from those reported under participant flow and baseline.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PCV13-vaccinated Participants | PCV13 Vaccine Effectiveness (VE) for First Event of Invasive Pneumococcal Disease (IPD): Overall Follow-up | 167 Participants |
| Unvaccinated Participants | PCV13 Vaccine Effectiveness (VE) for First Event of Invasive Pneumococcal Disease (IPD): Overall Follow-up | 747 Participants |
95% CI: [5.425, 36.391]
Primary
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)
Population: PCV13 vaccination status was a time varying exposure and participants could be counted in both PCV13 vaccinated or unvaccinated arms, depending on vaccination status during follow-up. Here, 'Overall Number of Participants Analyzed (N)' for Unvaccinated arm=participants unvaccinated at start of study evaluable for this outcome measure (OM); N for vaccinated arm=participants vaccinated by end of follow up for this OM; hence, N is different from those reported under participant flow and baseline.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PCV13-vaccinated Participants | PCV13 VE for First Event of All-cause Pneumonia (ACP): Overall Follow-up | 8098 Participants |
| Unvaccinated Participants | PCV13 VE for First Event of All-cause Pneumonia (ACP): Overall Follow-up | 34498 Participants |
95% CI: [5.705, 11.086]
Primary
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)
Population: PCV13 vaccination status was a time varying exposure and participants could be counted in both PCV13 vaccinated or unvaccinated arms, depending on vaccination status during follow-up. Here, 'Overall Number of Participants Analyzed (N)' for Unvaccinated arm=participants unvaccinated at start of study evaluable for this outcome measure (OM); N for vaccinated arm=participants vaccinated by end of follow up for this OM; hence, N is different from those reported under participant flow and baseline.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PCV13-vaccinated Participants | PCV13 VE for First Event of Pneumococcal Pneumonia (PP): Overall Follow-up | 309 Participants |
| Unvaccinated Participants | PCV13 VE for First Event of Pneumococcal Pneumonia (PP): Overall Follow-up | 1362 Participants |
95% CI: [3.994, 28.536]
Primary
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
Population: PCV13 vaccination status was a time varying exposure and participants could be counted in both PCV13 vaccinated or unvaccinated arms, depending on vaccination status during follow-up. Here, 'N' for Unvaccinated arm=number of participants unvaccinated at start of specified follow-up time evaluable for this OM; N for vaccinated arm=participants vaccinated by end of follow up time for this OM; hence, N is different from those reported under participant flow and baseline.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PCV13-vaccinated Participants | VE for First Event of ACP at 0-3 Years of Follow-up | 4543 Participants |
| Unvaccinated Participants | VE for First Event of ACP at 0-3 Years of Follow-up | 27984 Participants |
95% CI: [8.089, 14.679]
Primary
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
Population: PCV13 vaccination status was a time varying exposure and participants could be counted in both PCV13 vaccinated or unvaccinated arms, depending on vaccination status during follow-up. Here, 'N' for Unvaccinated arm=number of participants unvaccinated at start of specified follow-up time evaluable for this OM; N for vaccinated arm=participants vaccinated by end of follow up time for this OM; hence, N is different from those reported under participant flow and baseline.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PCV13-vaccinated Participants | VE for First Event of ACP at 3-5 Years of Follow-up | 2079 Participants |
| Unvaccinated Participants | VE for First Event of ACP at 3-5 Years of Follow-up | 4437 Participants |
95% CI: [1.427, 12.493]
Primary
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
Population: PCV13 vaccination status was a time varying exposure and participants could be counted in both PCV13 vaccinated or unvaccinated arms, depending on vaccination status during follow-up. Here, 'N' for Unvaccinated arm=number of participants unvaccinated at start of specified follow-up time evaluable for this OM; N for vaccinated arm=participants vaccinated by end of follow up time for this OM; hence, N is different from those reported under participant flow and baseline.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PCV13-vaccinated Participants | VE for First Event of ACP at 5-7 Years of Follow-up | 1200 Participants |
| Unvaccinated Participants | VE for First Event of ACP at 5-7 Years of Follow-up | 1757 Participants |
95% CI: [-12.626, 4.488]
Primary
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
Population: PCV13 vaccination status was a time varying exposure and participants could be counted in both PCV13 vaccinated or unvaccinated arms, depending on vaccination status during follow-up. Here, 'Overall Number of Participants Analyzed (N)' for Unvaccinated arm=participants unvaccinated at start of study evaluable for this OM; N for vaccinated arm=participants vaccinated by end of follow up for this OM; hence, N is different from those reported under participant flow and baseline.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PCV13-vaccinated Participants | VE for First Event of IPD at 0-3 Years of Follow-up | 73 Participants |
| Unvaccinated Participants | VE for First Event of IPD at 0-3 Years of Follow-up | 566 Participants |
95% CI: [13.249, 51.275]
Primary
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
Population: PCV13 vaccination status was a time varying exposure and participants could be counted in both PCV13 vaccinated or unvaccinated arms, depending on vaccination status during follow-up. Here, 'N' for Unvaccinated arm=number of participants unvaccinated at start of specified follow-up time evaluable for this OM; N for vaccinated arm=participants vaccinated by end of follow up time for this OM; hence, N is different from those reported under participant flow and baseline.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PCV13-vaccinated Participants | VE for First Event of IPD at 3-5 Years of Follow-up | 59 Participants |
| Unvaccinated Participants | VE for First Event of IPD at 3-5 Years of Follow-up | 116 Participants |
95% CI: [-50.408, 26.302]
Primary
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
Population: PCV13 vaccination status was a time varying exposure and participants could be counted in both PCV13 vaccinated or unvaccinated arms, depending on vaccination status during follow-up. Here, 'N' for Unvaccinated arm=number of participants unvaccinated at start of specified follow-up time evaluable for this OM; N for vaccinated arm=participants vaccinated by end of follow up time for this OM; hence, N is different from those reported under participant flow and baseline.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PCV13-vaccinated Participants | VE for First Event of IPD at 5-7 Years of Follow-up | 32 Participants |
| Unvaccinated Participants | VE for First Event of IPD at 5-7 Years of Follow-up | 54 Participants |
95% CI: [-46.883, 43.961]
Primary
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
Population: PCV13 vaccination status was a time varying exposure and participants could be counted in both PCV13 vaccinated or unvaccinated arms, depending on vaccination status during follow-up. Here, 'Overall Number of Participants Analyzed (N)' for Unvaccinated arm=participants unvaccinated at start of study evaluable for this outcome measure (OM); N for vaccinated arm=participants vaccinated by end of follow up for this OM; hence, N is different from those reported under participant flow and baseline.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PCV13-vaccinated Participants | VE for First Event of PP at 0-3 Years of Follow-up | 161 Participants |
| Unvaccinated Participants | VE for First Event of PP at 0-3 Years of Follow-up | 1092 Participants |
95% CI: [9.4, 38.781]
Primary
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
Population: PCV13 vaccination status was a time varying exposure and participants could be counted in both PCV13 vaccinated or unvaccinated arms, depending on vaccination status during follow-up. Here, 'N' for Unvaccinated arm=number of participants unvaccinated at start of specified follow-up time evaluable for this OM; N for vaccinated arm=participants vaccinated by end of follow up time for this OM; hence, N is different from those reported under participant flow and baseline.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PCV13-vaccinated Participants | VE for First Event of PP at 3-5 Years of Follow-up | 94 Participants |
| Unvaccinated Participants | VE for First Event of PP at 3-5 Years of Follow-up | 184 Participants |
95% CI: [-42.076, 18.569]
Primary
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
Population: PCV13 vaccination status was a time varying exposure and participants could be counted in both PCV13 vaccinated or unvaccinated arms, depending on vaccination status during follow-up. Here, 'N' for Unvaccinated arm=number of participants unvaccinated at start of specified follow-up time evaluable for this OM; N for vaccinated arm=participants vaccinated by end of follow up time for this OM; hence, N is different from those reported under participant flow and baseline.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PCV13-vaccinated Participants | VE for First Event of PP at 5-7 Years of Follow-up | 49 Participants |
| Unvaccinated Participants | VE for First Event of PP at 5-7 Years of Follow-up | 69 Participants |
95% CI: [-34.916, 41.871]
Secondary
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)
Population: PCV13 vaccination status was a time varying exposure and participants could be counted in both PCV13 vaccinated or unvaccinated arms, depending on vaccination status during follow-up. Here, 'N' for Unvaccinated arm=participants unvaccinated at start of study evaluable for this OM; N for vaccinated arm=participants vaccinated by end of follow up for this OM; hence, N is different from those reported under participant flow and baseline. .n:number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PCV13-vaccinated Participants | 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 | 0-3 Years | 3996 Participants |
| PCV13-vaccinated Participants | 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 | 3-5 Years | 1886 Participants |
| PCV13-vaccinated Participants | 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 | 5-7 Years | 1031 Participants |
| PCV13-vaccinated Participants | 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 | Overall follow up | 7155 Participants |
| Unvaccinated Participants | 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 | Overall follow up | 30139 Participants |
| Unvaccinated Participants | 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 | 0-3 Years | 24423 Participants |
| Unvaccinated Participants | 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 | 5-7 Years | 1460 Participants |
| Unvaccinated Participants | 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 | 3-5 Years | 3979 Participants |
Comparison: IPTW\*IPCW + imbalanced variables: 0-3 years95% CI: [10.213, 17.022]
Comparison: IPTW\*IPCW + imbalanced variables: 3-5 years95% CI: [1.707, 13.261]
Comparison: IPTW\*IPCW + imbalanced variables: 5-7 years95% CI: [-15.691, 3.26]
Comparison: IPTW\*IPCW + imbalanced variables: overall follow up95% CI: [7.056, 12.66]
Secondary
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)
Population: PCV13 vaccination status was a time varying exposure and participants could be counted in both PCV13 vaccinated or unvaccinated arms, depending on vaccination status during follow-up. Here, 'N' for Unvaccinated arm=participants unvaccinated at start of study evaluable for this OM; N for vaccinated arm=participants vaccinated by end of follow up for this OM; hence, N is different from those reported under participant flow and baseline. .n:number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PCV13-vaccinated Participants | PCV13 VE for First Event of Pneumonia With Unspecified Causes at 0-3, 3-5, 5-7 and Overall Years of Follow-up | 0-3 Years | 3980 Participants |
| PCV13-vaccinated Participants | PCV13 VE for First Event of Pneumonia With Unspecified Causes at 0-3, 3-5, 5-7 and Overall Years of Follow-up | 3-5 Years | 1881 Participants |
| PCV13-vaccinated Participants | PCV13 VE for First Event of Pneumonia With Unspecified Causes at 0-3, 3-5, 5-7 and Overall Years of Follow-up | 5-7 Years | 1030 Participants |
| PCV13-vaccinated Participants | PCV13 VE for First Event of Pneumonia With Unspecified Causes at 0-3, 3-5, 5-7 and Overall Years of Follow-up | Overall follow up | 7133 Participants |
| Unvaccinated Participants | PCV13 VE for First Event of Pneumonia With Unspecified Causes at 0-3, 3-5, 5-7 and Overall Years of Follow-up | Overall follow up | 30010 Participants |
| Unvaccinated Participants | PCV13 VE for First Event of Pneumonia With Unspecified Causes at 0-3, 3-5, 5-7 and Overall Years of Follow-up | 0-3 Years | 24302 Participants |
| Unvaccinated Participants | PCV13 VE for First Event of Pneumonia With Unspecified Causes at 0-3, 3-5, 5-7 and Overall Years of Follow-up | 5-7 Years | 1461 Participants |
| Unvaccinated Participants | PCV13 VE for First Event of Pneumonia With Unspecified Causes at 0-3, 3-5, 5-7 and Overall Years of Follow-up | 3-5 Years | 3970 Participants |
Comparison: IPTW\*IPCW + imbalanced variables: 0-3 years95% CI: [10.149, 16.978]
Comparison: IPTW\*IPCW + imbalanced variables: 3-5 years95% CI: [1.708, 13.276]
Comparison: IPTW\*IPCW + imbalanced variables: 5-7 years95% CI: [-15.809, 3.166]
Comparison: IPTW\*IPCW + imbalanced variables: overall follow up95% CI: [7, 12.617]