A Study to Learn How Effective is PCV20 to Help Stop Adults Who Have a Higher Chance of Getting Pneumonia

NCT07251465 · tracked via the Priya Life Science USA tracker

Sponsor

Pfizer

Phase

Observational

Started

2026-01-21

Last updated

2026-10-27

Condition(s) studied

Community-Acquired Pneumonia (CAP)

Investigational drug(s) / intervention(s)

Receipt of PCV20

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

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  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

Trial sites (1)

Facility	City	Region	Status
Pfizer	New York	New York

More Pfizer trials in the USA

A Study to Learn About the Medicine Called PF-08653944 in People With and Without Reduced Liver Function Recruiting

A Long-term Study of the Medicine Called Abrocitinib in Children Aged 2 Years and Older With Moderate to Severe Eczema Recruiting

A Study to Learn About How Food Affects the Uptake of Study Medicine Prifetrastat Into the Blood in Healthy Adults Starting soon

A Study of PF-08653945 and PF-08653944 in Adults With Overweight or Obesity Active, not recruiting

A Study to Learn How the Study Medicine Called Atirmociclib is Handled by the Body in People With Normal Liver Function and Different Levels of Liver Disease Recruiting

Other trials for the same condition

A Study to Learn About How Well the Prevnar 20 Vaccine Works for Pneumonia in People Who Are 65 Years and Older Active, not recruiting

Official registry record

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.

View NCT07251465 on ClinicalTrials.gov ↗ ← All trials in the USA