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Active, not recruiting

NCT Number: NCT07251465

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

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Community-Acquired Pneumonia (CAP) Community-Acquired Infections Community-Acquired Pneumonia Infections Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer

New York, 10001, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Aged ≥19 at some point between July 1, 2022 and May 31, 2025 with 1-year continuous membership prior to July 1, 2022
  • ≥1 year of continuous enrollment as a KPSC member prior to the index date, allowing for 45-day administrative gaps
  • Age ≥65 years on the index date
  • At least one outpatient visit prior to the index date

Exclusion criteria

19-64 years of age cohort

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  • Received PCV20 prior to June 1, 2022, turning age 19 years, or meeting the medical condition or behavioral risk factor inclusion criteria
  • 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
  • Received PCV15 or PCV21 prior to the index date
  • Received PPSV23 ≤2 years prior to the index date
  • Received PCV13 ≤5 years prior to the index date
  • Outcome-related diagnosis code in the EHR <30 days prior to the index date
  • 65 years cohort
  • Received PCV20 prior to June 1, 2022 or prior to turning ≥65 years of age
  • 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
  • Received PCV15 or PCV21 prior to the index date
  • Received PPSV23 ≤2 years prior to the index date
  • Received PCV13 ≤5 years prior to the index date
  • Outcome-related diagnosis code in the EHR <30 days prior to the index date

Treatment and study plan

Receipt of PCV20

Biological

The main exposure of interest will be receipt of PCV20.

Primary outcomes

  1. 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

    Time frame: 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

Secondary outcomes

  1. 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

    Time frame: 3 years

    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

  2. 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

    Time frame: 3 years

    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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

  • Kaiser Permanente

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Nov 26, 2025
Registry last updated
Aug 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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