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| Name | Class |
|---|---|
| Kaiser Permanente | OTHER |
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The purpose of this study is to learn how effective is PCV20 to help stop adults from getting pneumonia. Pneumonia is an infection of the lungs that can be caused by germs like bacteria, virus, or fungi. This study uses existing healthcare information. No participants will be actively enrolled. The information of participants will be taken from Kaiser Permanente Southern California's (KPSC) electronic health records (EHR).
We will look at the EHR information for adults who meet the following points:
The study will begin from 01 July 2022 and will be followed through 30 June 2025. At the end of the follow-up period, the study will compare the number of pneumonia cases among people who receive PCV20 who do not receive it.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adults ≥18-64 years old with medical conditions and behavioral risk factors |
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| Adults ≥65 years old |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Receipt of PCV20 | Biological | The main exposure of interest will be receipt of PCV20. |
|
| Measure | Description | Time Frame |
|---|---|---|
| PCV20 vaccine effectiveness (VE) against all-cause pneumonia (ACP) calculated as (1- adjusted hazard ratio [aHR]) × 100% among adults aged ≥18-64 years with medical conditions and behavioral risk factors and among adults ≥65 years old, combined | Estimate overall PCV20 effectiveness against ACP among both adults ≥18-64 years old with medical conditions and behavioral risk factors and among adults ≥65 years old combined | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence calculated the number of all-cause pneumonia episodes per 100,000 population among both adults ≥18-64 years old with medical conditions and behavioral risk factors and among adults ≥65 years old combined, and each group separately | Estimate the incidence of all-cause pneumonia by PCV20 vaccination status among both adults ≥18-64 years old with medical conditions and behavioral risk factors and among adults ≥65 years old combined, and each group separately. |
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Inclusion Criteria:
Exclusion Criteria:
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The cohort consisting of adults ≥18 years who meet eligibility criteria as of 01 July 2022 or who become eligible for the cohort thereafter until the end of the cohort follow-up (30 June 2025) will be classified according to PCV20 exposure and followed until the outcomes of interest, loss to follow-up (i.e., health plan disenrollment or death), or the end of the study period, whichever occurs first. Cohort members will contribute time-segments of unvaccinated or vaccinated follow-up time beginning at the first health care visit after cohort entry for unvaccinated time-segments and at 30-days after PCV20 receipt for vaccinated time segments. During the follow-up period, adults who age into the cohort or who are newly diagnosed with a medical condition recommended for pneumococcal vaccination will be eligible for cohort entry so long as the other eligibility criteria are met.
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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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| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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No biospecimens collected.
| 3 years |
| Vaccine preventable disease incidence (VPDI) calculated as the difference in incidence rates of all-cause pneumonia for the PCV20 unvaccinated and PCV20 vaccinated groups | Estimate the absolute difference in the incidence of all-cause pneumonia by PCV20 vaccination status among both adults ≥18-64 years old with medical conditions and behavioral risk factors and among adults ≥65 years old combined, and each group separately. | 3 years |
| PCV20 VE against ACP calculated as (1-aHR) × 100% separately among adults aged ≥18-64 years with medical conditions and behavioral risk factors and among adults ≥65 years old | Estimate overall PCV20 effectiveness against ACP separately among adults ≥18-64 years old with medical conditions and behavioral risk factors or among adults ≥65 years old | 3 years |