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

NCT ID: NCT07251465

Last Updated: 2025-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

846279 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-15

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pneumonia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Adults ≥18-64 years old with medical conditions and behavioral risk factors

Receipt of PCV20

Intervention Type BIOLOGICAL

The main exposure of interest will be receipt of PCV20.

Adults ≥65 years old

Receipt of PCV20

Intervention Type BIOLOGICAL

The main exposure of interest will be receipt of PCV20.

Interventions

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Receipt of PCV20

The main exposure of interest will be receipt of PCV20.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. PCV15 received any time before or after the cohort entry date;
2. 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;
3. Kaiser Permanente Southern California (KPSC) members with zero outpatient visits.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaiser Permanente

OTHER

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Central Contacts

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Pfizer CT.gov Call Center

Role: CONTACT

1-800-718-1021

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=B7471041

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

Other Identifiers

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B7471041

Identifier Type: -

Identifier Source: org_study_id

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