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

EFFECTIVENESS OF PNEUMOCOCCAL VACCINATION (PCV20) TO PREVENT ALL-CAUSE PNEUMONIA AND LOWER RESPIRATORY TRACT INFECTIONS AMONG ADULTS ≥19 YEARS OF AGE WITH AN INCREASED RISK OF PNEUMOCOCCAL DISEASE AT KAISER PERMANENTE SOUTHERN CALIFORNIA

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Community-Acquired Pneumonia (CAP)
• Intervention / Treatment: Biological: Receipt of PCV20

• Study Type: Observational
• Enrollment (Actual): 846279

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10001
      • Pfizer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study will include a cohort of adults 19-64 years of age with at least one medical or behavioral risk factor associated with an increased risk of pneumococcal disease and a cohort of adults ≥65 years of age. Individuals who meet the eligibility criteria as of 01 July 2022 or who become eligible during the cohort identification period (01 July 2022 through 31 May 2025) will be included in the study. Individuals could contribute to both the 19-64 and ≥65 years of age cohorts if the individual met the inclusion and exclusion criteria for each respective cohort. Follow-up time will be classified by PCV20 exposure status. Within each cohort (19-64, ≥65 years), individuals can contribute one PCV20-unvaccinated time-segment, one PCV20-vaccinated time-segment, or both.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adults ≥19-64 years old with medical conditions and behavioral risk factors; For the 19-64 years of age cohort, the unvaccinated index date is the earliest day during the cohort identification period when the individual is 19-64 years of age, has ≥1 year of prior continuous enrollment, and has a medical or behavioral risk factor during the prior 1-year continuous enrollment period. The vaccinated index is the day during the cohort identification period that is 30 days after PCV20 vaccination received when the individual has ≥1 year of prior continuous enrollment, is 19-64 years of age, and has a risk factor identified during the prior 1-year continuous enrollment period.	Biological: Receipt of PCV20; The main exposure of interest will be receipt of PCV20.
Adults ≥65 years old; For the ≥65 years of age cohort, the unvaccinated index date is the earliest day between 01 July 2022 and 31 May 2025 (cohort identification period) when the individual is ≥65 years of age and has ≥1 year of prior continuous enrollment. The vaccinated index date is the date during the cohort identification period that is 30 days after PCV20 vaccination received when the individual is ≥65 years of age and has ≥1 year of prior continuous enrollment.	Biological: Receipt of PCV20; The main exposure of interest will be receipt of PCV20.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence rates calculated separately among adults 19-64 years of age with medical conditions or behavioral risk factors and among adults ≥65 years of age	Unweighted and unadjusted incidence rates will be calculated as the number of ACP episodes per 100,000 person-years overall and separately for PCV20-vaccinated and unvaccinated time-segments. Incidence rates will be calculated separately among adults 19-64 years of age with medical conditions or behavioral risk factors and among adults ≥65 years of age	3 years
Absolute rate reduction of ACP associated with PCV20 vaccination calculated separately among adults 19-64 years of age with medical conditions or behavioral risk factors and among adults ≥65 years of age	Absolute rate reduction of ACP associated with PCV20 vaccination will be calculated using the weighted VE estimate from the Cox proportional hazards model along with the non-model based unadjusted incidence rate (IR) during PCV20-vaccinated follow-up time. Absolute rate reduction will be calculated separately among adults 19-64 years of age with medical conditions or behavioral risk factors and among adults ≥65 years of age.	3 years

Collaborators and Investigators

• Sponsor: Pfizer
• Collaborators: Kaiser Permanente
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: August 20, 2025
• First Submitted That Met QC Criteria: November 18, 2025
• First Posted (Actual): November 26, 2025

Study Record Updates

• Last Update Posted (Actual): August 25, 2026
• Last Update Submitted That Met QC Criteria: August 21, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Vaccines; Respiratory tract infections
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Pneumonia; Community-Acquired Infections; Respiratory Tract Infections; Community-Acquired Pneumonia
• Other Study ID Numbers: B7471041

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No