A Study to Learn About How 20-Valent Pneumococcal Conjugate Vaccine Works in a Real-world Setting

RECRUITING

NCT05452941

Sponsor: Pfizer

Summary

The purpose of this study is to learn about how well the 20-valent pneumococcal conjugate vaccine (20vPnC) works against radiologically-confirmed community-acquired pneumonia (RAD+CAP) due to the 7 new serotypes (types of a bacteria called Streptococcus pneumoniae that cause pneumonia) included in 20vPnC vaccine. This study is seeking participants who: * are male or female ≥65 years of age. * are hospitalized with physician suspicion of community acquired pneumonia (CAP). * have pneumonia confirmed with imaging like a chest x-ray Participants will be asked to provide demographic and medical history information, and to provide a urine sample that will be used to test for pneumonia caused by specific strains of a bacteria called Streptococcus pneumoniae. We will compare the proportion of participants who have pneumonia caused by specific strains of the bacteria Streptococcus pneumoniae and were previously vaccinated with 20vPnC with the proportion of participants who have pneumonia caused by something other than vaccine type Streptococcus pneumoniae and have been vaccinated with 20vPnC. Participants will actively take part in the study for about 1-2 days. Information on participant's illness and hospitalization details will be collected through day 30 of their hospitalization through medical chart review.

Official title: A Phase 4 Study Using a Test-Negative Design to Evaluate the Effectiveness of a 20-valent Pneumococcal Conjugate Vaccine Against Vaccine-type Radiologically-confirmed Community-acquired Pneumonia in Adults >/= 65 Years of Age

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

OBSERVATIONAL

Enrollment

12500

Start Date

2022-10-27

Completion Date

2027-06-04

Last Updated

2026-05-11

Healthy Volunteers

No

Conditions

Pneumonia

Interventions

DIAGNOSTIC_TEST

Diagnostic test on urine samples

Testing by BinaxNOW® S. pneumoniae and serotype-specific urine antigen detection (UAD) assays (UAD-1 and UAD-2).

Locations (54)

El Centro Regional Medical Center

El Centro, California, United States

Kaiser Permanente Fontana Medical Center

Fontana, California, United States

Kaiser Permanente West Los Angeles Medical Center

Los Angeles, California, United States

Kaiser Permanente Vaccine Study Center

Oakland, California, United States

Kaiser Permanente Oakland Medical Center

Oakland, California, United States

Kaiser Permanente Ontario Medical Center

Ontario, California, United States

Southern California Permanente Medical Group (SCPMG)

Pasadena, California, United States

Kaiser Permanente Riverside Medical Center

Riverside, California, United States

Kaiser Permanente Roseville Medical Center

Roseville, California, United States

Kaiser Permanente South Sacramento Medical Center

Sacramento, California, United States

Kaiser Permanente Sacramento Medical Center

Sacramento, California, United States

Kaiser Permanente Zion Medical Center

San Diego, California, United States

Kaiser Permanente San Diego Medical Center

San Diego, California, United States

Kaiser Permanente Santa Clara Medical Center

Santa Clara, California, United States

Kaiser Permanente South San Francisco Medical Center

South San Francisco, California, United States

Kaiser Permanente Walnut Creek Medical Center

Walnut Creek, California, United States

Starling Physicians

Hartford, Connecticut, United States

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Emory Children's Center - Vaccine Research Clinic (ECC-VRC)

Atlanta, Georgia, United States

Emory University Hospital

Atlanta, Georgia, United States

University of Louisville School of Medicine, Division of Infectious Diseases