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

N/ANot Yet RecruitingNCT07251465

Pfizer846,279 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

846,279

Conditions

Pneumonia

Interventions

Receipt of PCV20BIOLOGICAL

The main exposure of interest will be receipt of PCV20.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

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

Time frame: 3 years

Secondary Outcomes

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

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.

Time frame: 3 years

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

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.

Time frame: 3 years

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

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

Time frame: 3 years

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

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts