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

NCT07251465 | Active Not Recruiting FDA Drug

• 1 other identifier: B7471041
• Study Type: observational
• Target: 846,279
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pneumonia

Keywords

respiratory tract infections; vaccines

Outcome Measures

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

  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

  3 years

Secondary Outcomes (3)

• 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

  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

  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

  3 years

Study Arms (2)

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

Biological: Receipt of PCV20

Adults ≥65 years old

Biological: Receipt of PCV20

Interventions

Receipt of PCV20 BIOLOGICAL

The main exposure of interest will be receipt of PCV20.

Adults ≥18-64 years old with medical conditions and behavioral risk factors; Adults ≥65 years old

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The cohort consisting of adults ≥18 years who meet eligibility criteria as of 01 July 2022 or who become eligible for the cohort thereafter until the end of the cohort follow-up (30 June 2025) will be classified according to PCV20 exposure and followed until the outcomes of interest, loss to follow-up (i.e., health plan disenrollment or death), or the end of the study period, whichever occurs first. Cohort members will contribute time-segments of unvaccinated or vaccinated follow-up time beginning at the first health care visit after cohort entry for unvaccinated time-segments and at 30-days after PCV20 receipt for vaccinated time segments. During the follow-up period, adults who age into the cohort or who are newly diagnosed with a medical condition recommended for pneumococcal vaccination will be eligible for cohort entry so long as the other eligibility criteria are met.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead
• Kaiser Permanente: collaborator

Study Sites (1)

Pfizer

New York, New York, 10001, United States

Location

Related Links

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

Biospecimen

Retention: NONE RETAINED

No biospecimens collected.

MeSH Terms

Conditions

Pneumonia; Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: November 26, 2025
• Study Start: January 21, 2026
• Primary Completion: July 31, 2026
• Study Completion: July 31, 2026
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)