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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 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:

* 18 years of age or older and a KPSC member as of 01 July 2022. * have been a KPSC member for at least one year before 01 July 2022. * have not received PCV15. * have had pneumonia or lower respiratory tract infection within 30 days of 01 July 2022.

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Pneumonia Infections Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 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

  • Aged ≥18 years at cohort entry;
  • Continuous enrollment, allowing for 45-day administrative gap, for at least one year prior to cohort entry;
  • At least one outpatient visit in the prior to cohort entry.

Exclusion criteria

  • PCV15 received any time before or after the cohort entry date;
  • a diagnosis code in the electronic health record (EHR) for pneumonia or lower respiratory tract infection (LRTI) was made within 30 days prior to cohort entry;
  • Kaiser Permanente Southern California (KPSC) members with zero outpatient visits.

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) 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

    Time frame: 3 years

    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

Secondary outcomes

  1. 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

    Time frame: 3 years

    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.

  2. Vaccine preventable disease incidence (VPDI) calculated as the difference in incidence rates of all-cause pneumonia for the PCV20 unvaccinated and PCV20 vaccinated groups

    Time frame: 3 years

    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. 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

    Time frame: 3 years

    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

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 ≥18 YEARS OLD 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
Jun 22, 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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