Receipt of PCV20: The main exposure of interest will be receipt of PCV20.
Study summary
The purpose of this study is to learn how well PCV20 stops adults from getting community-acquired 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:
* 19 years of age or older and a KPSC member between 01 July 2022 and 31 May 2025.
* have higher risk of pneumococcal disease due to older age or a chronic medical condition
* have been a KPSC member for the year before joining the study and for at least one year before 01 July 2022.
* have not received PCV15, PCV21, PPSV23 (2 years before), or PCV13 (5 years before) joining the study.
* have not received PCV20 before 01 June 2022.
* have not received PCV20 before turning 65 or before having a chronic medical condition which has higher risk of pneumococcal disease.
* have had at least one outpatient visit.
* have not had pneumonia or lower respiratory tract infection within 30 days of joining the study.
The study will begin on 01 July 2022 and end on 30 June 2025. At the end of the follow-up period, the study will compare the number of community-acquired pneumonia cases among people who did and did not receive PCV20.
Eligibility
Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
19-64 years of age cohort 1. Aged ≥19 at some point between July 1, 2022 and May 31, 2025 with 1-year continuous membership prior to July 1, 2022 2. At least 1 year of continuous enrollment as a KPSC member prior to the index date, allowing for 45-day administrative gaps 3. Age 19-64 years of age on the index date with ≥1 medical condition or risk factor identified during the 1-year continuous enrollment period prior to the index date 4. At least one outpatient visit prior to the index date
* 65 years cohort
1. Aged ≥19 at some point between July 1, 2022 and May 31, 2025 with 1-year continuous membership prior to July 1, 2022
2. ≥1 year of continuous enrollment as a KPSC member prior to the index date, allowing for 45-day administrative gaps
3. Age ≥65 years on the index date
4. At least one outpatient visit prior to the index date
Exclusion Criteria:
19-64 years of age cohort
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1. Received PCV20 prior to June 1, 2022, turning age 19 years, or meeting the medical condition or behavioral risk factor inclusion criteria
2. Vaccinated index date is \>30 days after the first PCV20 vaccination date or \>1 dose of PCV20 is received \<30 days prior to the index date
3. Received PCV15 or PCV21 prior to the index date
4. Received PPSV23 ≤2 years prior to the index date
5. Received PCV13 ≤5 years prior to the index date
6. Outcome-related diagnosis code in the EHR \<30 days prior to the index date
* 65 years cohort
1. Received PCV20 prior to June 1, 2022 or prior to turning ≥65 years of age
2. Vaccinated index date is \>30 days after the first PCV20 vaccination date or \>1 dose of PCV20 is received \<30 days prior to the index date
3. Received PCV15 or PCV21 prior to the index date
4. Received PPSV23 ≤2 years prior to the index date
5. Received PCV13 ≤5 years prior to the index date
6. Outcome-related diagnosis code in the EHR \<30 days prior to the index date
Primary outcome measure(s)
PCV20 vaccine effectiveness (VE) against all-cause pneumonia (ACP) separately among both adults 19-64 years of age with medical conditions and behavioral risk factors and among adults ≥65 years of age — 3 years PCV20 VE against ACP calculated as (1-aHR) × 100% separately among adults aged 19-64 years with medical conditions or behavioral risk factors and among adults ≥65 years of age
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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