A Study to Learn About How Well the Prevnar 20 Vaccine Works for Pneumonia in People Who Are 65 Years and Older

NCT06782282 | Active Not Recruiting

• 1 other identifier: B7471043
• Study Type: observational
• Target: 22,234,435
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to learn about how well the Prevnar 20 vaccine (PCV20) stops invasive pneumococcal disease (a group of severe infections caused by a bacteria called Streptococcus pneumoniae), pneumococcal pneumonia (a bacterial lung disease caused by the germ Streptococcus pneumoniae), all-cause pneumonia (pneumonia caused by any germ including bacteria, a virus, or a fungus), and lower respiratory tract infection (infection of the lower airways in the lung) in people 65 years and older. This study will use a database of people who have Medicare insurance with names and other identifying information removed. This study will include people who:

• are 65 years and older,
• live in one of the 50 United States or Washington DC, and
• are enrolled in Medicare Fee-for-Service Parts A and B for at least 1 year. The study uses data that is already being collected and no treatment or vaccine will be given in the study. People that fit the description above will be followed in the Medicare database for about two years. Their information will be reviewed to see if they had vaccines for pneumonia or had certain health events, such as pneumonia or lower respiratory tract infection. The experiences of people that received Prevnar 20 will be compared to the experiences of people that did not receive the vaccine. This will help to show how well Prevnar 20 works at stopping invasive pneumococcal disease, pneumococcal pneumonia, all-cause pneumonia, and lower respiratory tract infection.

Conditions

Community-Acquired Pneumonia (CAP)

Outcome Measures

Primary Outcomes (6)

• Weighted PCV20 vaccine effectiveness (VE) against Invasive Pneumococcal Disease (IPD)

  Presence of International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes (1 inpatient or 1 outpatient in any diagnostic position) representing IPD

  Time to pneumococcal vaccination, disenrollment from Medicare FFS Parts A or B, enrollment in Medicare Part C, death, or IPD up to 24 months

• Weighted PCV20 VE against Pneumococcal Pneumonia (PP)

  ICD-10-CM codes (1 inpatient or 1 outpatient in any diagnostic position) representing PP

  Time to pneumococcal vaccination, disenrollment from Medicare FFS Parts A or B, enrollment in Medicare Part C, death, or PP up to 24 months

• Absolute difference in the incidence of PP by PCV20 vaccination status

  ICD-10-CM codes (1 inpatient or 1 outpatient in any diagnostic position) representing PP

  Time to pneumococcal vaccination, disenrollment from Medicare FFS Parts A or B, enrollment in Medicare Part C, death, or PP up to 24 months

• Weighted PCV20 VE against all cause pneumonia (ACP)

  ICD-10-CM codes (1 inpatient or 1 outpatient in any diagnostic position) representing ACP

  Time to pneumococcal vaccination, disenrollment from Medicare FFS Parts A or B, enrollment in Medicare Part C, death, or ACP up to 24 months

• Absolute difference in incidence of ACP by PCV20 vaccination status

  ICD-10-CM codes (1 inpatient or 1 outpatient in any diagnostic position) representing ACP

  Time to pneumococcal vaccination, disenrollment from Medicare FFS Parts A or B, enrollment in Medicare Part C, death, or ACP up to 24 months

• Absolute difference in the incidence of IPD by PCV20 vaccination status

  Presence of International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes (1 inpatient or 1 outpatient in any diagnostic position) representing IPD

  Time to pneumococcal vaccination, disenrollment from Medicare FFS Parts A or B, enrollment in Medicare Part C, death, or IPD up to 24 months

Secondary Outcomes (2)

• Weighted PCV20 VE against Lower Respiratory Tract Infection (LRTI)

  Time to pneumococcal vaccination, disenrollment from Medicare FFS Parts A or B, enrollment in Medicare Part C, death, or LRTI up to 24 months

• Absolute difference in incidence of LRTI by PCV20 vaccination status

  Time to pneumococcal vaccination, disenrollment from Medicare FFS Parts A or B, enrollment in Medicare Part C, death, or LRTI up to 24 months

Study Arms (2)

PCV20 Vaccinated

Aged ≥65 years and vaccinated with PCV20 during the study identification period

PCV20 Unvaccinated

Aged ≥65 years and not vaccinated with PCV20 during the study identification period

Eligibility Criteria

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

Study Population

Aged ≥65 years, residing in one of the 50 US states or in Washington, D.C., continuously enrollmed in Medicare FFS Parts A and B for 365 days prior to the index date, allowing for gaps of ≤45 days (baseline period)

Patients from the Medicare database to be included in the analysis must be: * aged 65 or older as of 28Jan22 (date of 20-valent pneumococcal conjugate vaccine (PCV20) * residing in one of the 50 US states or Washington DC * be continuously enrolled in Medicare Fee for Service Parts A and B for 365 days prior to the index date allowing for gaps of up to 45 days (baseline period) Patients from the Medicare database will be excluded from the analysis if: * there is a record of death prior to the index date * the patient was enrolled in Medicare Part C at any point between 28Jan22 and the index date * the patient received PCV20 before 01Jul22 * the patient received PCV15 prior to the index date * sex information is missing If the patient received the pneumococcal polysaccharide vaccine (PPSV23) within 2 years prior to index date, the corresponding time segment (ie 2 years prior to index date) will be excluded. If the patient received PCV13 within the past 5 years prior to the index date, the corresponding time segment (ie 5 years prior to index date) will be excluded. However, those who received PCV13 more than 5 years prior to index date will still have all data included in primary analyses. For PCV20 period, exclude those when IPD, PP, ACP or LRTI outcome incurred between PCV20 vaccination date and prior to the index date (a 30-day blackout period).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer United States

New York, New York, 10017, United States

Location

Related Links

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

MeSH Terms

Conditions

Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: January 3, 2025
• First Posted: January 17, 2025
• Study Start: January 20, 2025
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)