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

Pfizer

Status: Not yet enrolling

Conditions: Pneumonia

Treatments: Biological: Receipt of PCV20

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07251465

B7471041

Details and patient eligibility

About

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.

Enrollment: 846,279 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

846,279 participants in 2 patient groups

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

Treatment:

Biological: Receipt of PCV20

Adults ≥65 years old

Treatment:

Biological: Receipt of PCV20