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| ID | Type | Description | Link |
|---|---|---|---|
| NCT05794191 | Registry Identifier | ClinicalTrials.gov |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Persons living with HIV (PLWH) | Adults with HIV |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaccine Administration | Biological | PCV13 administration |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
1. Evidence of PCV13 vaccination before the first HIV-related code
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People with HIV in a healthcare administrative database
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer | New York | New York | 10001 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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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).
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | PCV13-vaccinated Participants | Participants with an HIV diagnosis code who received 13-valent pneumococcal conjugate vaccine (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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Analysis population included all eligible participants whose data were retrieved and observed in the study. Baseline characteristics were analyzed in participants with vaccinated (PCV13 vaccinated participants) and unvaccinated (Unvaccinated participants) status at the index date, which was defined as the last day of baseline period.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | 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. | Posted | Count of Participants | Participants | From index date to the earliest of death, end of health plan enrollment or end of study period (maximum up to 8.25 years) |
All-cause mortality and adverse events were not planned to be collected; hence, time frame was not applicable.
In this observational retrospective study of deidentified database individual identifying information was not available. Minimum criteria for reporting an adverse event could not be met, hence all-cause mortality, serious adverse events (SAEs) and other AEs were not planned to be collected. Thus reporting "0" participants at risk.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 18007181021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 6, 2023 | Aug 15, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 7, 2023 | Aug 15, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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. | 5 to 7 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 | 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). | 0 to 3 years, 3 to 5 years and 5 to 7 years of follow-up (maximum up to 8.25 years) |
| BG001 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| 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). | 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. | Posted | Count of Participants | Participants | 0 to 3 years of follow up |
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| 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). | 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. | Posted | Count of Participants | Participants | 3 to 5 years of follow up |
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| 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). | 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. | Posted | Count of Participants | Participants | 5 to 7 years of follow up |
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| 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). | 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. | Posted | Count of Participants | Participants | From index date to the earliest of death, end of health plan enrollment or end of study period (maximum up to 8.25 years) |
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| 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). | 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. | Posted | Count of Participants | Participants | 0 to 3 years of follow up |
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| 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). | 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. | Posted | Count of Participants | Participants | 3 to 5 years of follow up |
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| 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). | 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. | Posted | Count of Participants | Participants | 5 to 7 years of follow up |
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| 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). | 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. | Posted | Count of Participants | Participants | From index date to the earliest of death, end of health plan enrollment or end of study period (maximum up to 8.25 years) |
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| 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). | 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. | Posted | Count of Participants | Participants | 0 to 3 years of follow up |
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| 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). | 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. | Posted | Count of Participants | Participants | 3 to 5 years of follow up |
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| 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. | 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. | Posted | Count of Participants | Participants | 5 to 7 years of follow up |
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| 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). | 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. | Posted | Count of Participants | Participants | 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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| 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). | 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. | Posted | Count of Participants | Participants | 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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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D013290 |
| Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| Unknown |
|
| 3-5 Years |
|
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| 5-7 Years |
|
|
| Overall follow up |
|
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| Vaccine effectiveness percentage |
| 7.665 |
| 2-Sided |
| 95 |
| 1.707 |
| 13.261 |
| Superiority |
| IPTW*IPCW + imbalanced variables: 5-7 years | Vaccine effectiveness percentage | -5.792 | 2-Sided | 95 | -15.691 | 3.260 | Superiority |
| IPTW*IPCW + imbalanced variables: overall follow up | Vaccine effectiveness percentage | 9.902 | 2-Sided | 95 | 7.056 | 12.660 | Superiority |
| 3-5 Years |
|
|
| 5-7 Years |
|
|
| Overall follow up |
|
|
| Vaccine effectiveness percentage |
| 7.673 |
| 2-Sided |
| 95 |
| 1.708 |
| 13.276 |
| Superiority |
| IPTW*IPCW + imbalanced variables: 5-7 years | Vaccine effectiveness percentage | -5.897 | 2-Sided | 95 | -15.809 | 3.166 | Superiority |
| IPTW*IPCW + imbalanced variables: overall follow up | Vaccine effectiveness percentage | 9.853 | 2-Sided | 95 | 7.000 | 12.617 | Superiority |