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A Study to Learn About How 20...

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

Last Updated: 2026-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

12500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-27

Study Completion Date

2027-06-04

Brief Summary

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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.

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Detailed Description

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This is an observational test-negative design study in which all study participants are adults ≥65 years of age hospitalized with RAD+CAP at one of the study sites. The only protocol-specified study procedure is a non-invasive urine specimen collection for pneumococcal detection using BinaxNOW® S. pneumoniae and the serotype-specific urinary antigen detection (UAD) assays. Cases and controls will be differentiated by the presence of vaccine serotypes that are identified by any method, including Quellung reaction of pneumococcal isolates obtained from standard of care (SOC) cultures from blood or high-quality respiratory tract specimens, or serotype specific UAD assays performed on urine specimens. The serotype-specific UAD assays, termed UAD-1 and UAD-2, detect the 13 serotypes in 13vPnC (1, 3, 4, 5, 6A/C, 6B/D, 7F/A, 9V/A, 14, 18C/A/ B/ F, 19A, 19F, 23F) (UAD-1) and 11 additional serotypes (2, 8, 9N, 10A/39, 11A/D/F, 12F, 15B/C, 17F/A, 20A/B, 22F/A, 33F/A) (UAD-2). For the primary objective, cases will be defined as participants hospitalized for RAD+CAP in whom the 7 additional serotypes in 20vPnC beyond 13vPnC plus 15C are identified. All other participants who meet study inclusion criteria but for whom 20vPnC serotypes are not identified from any source and all other RAD+CAP of non-pneumococcal etiologies will serve as test-negative controls.

Conditions

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Pneumonia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Case

Cases will be defined as participants hospitalized for RAD+CAP in whom the 7 additional serotypes in 20vPnC beyond 13vPnC plus 15C are identified.

Diagnostic test on urine samples

Intervention Type DIAGNOSTIC_TEST

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

Control

All other participants who meet study inclusion criteria but for whom 20vPnC serotypes are not identified from any source and all other RAD+CAP of non-pneumococcal etiologies will serve as test-negative controls.

Diagnostic test on urine samples

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Diagnostic test on urine samples

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Male or female participants ≥65 years of age.
2. Hospitalized participant with physician clinical suspicion of CAP with the presence of ≥2 of the following 10 clinical signs or symptoms:

* fever (oral temperature \>38.0°C/100.4°F or tympanic temperature \>38.5°C/101.2°F),
* hypothermia (\<35.5°C/95.9°F measured by a healthcare provider)
* chills or rigors,
* pleuritic chest pain,
* new or worsening cough,
* sputum production,
* dyspnea (shortness of breath),
* tachypnea (respiratory rate \>20/min),
* malaise, or
* abnormal auscultatory findings suggestive of pneumonia (rales or evidence of pulmonary consolidation including dullness on percussion, bronchial breath sounds, or egophony).
3. Has a radiographic finding that is consistent with pneumonia (e.g., pleural effusion, increased pulmonary density due to infection, the presence of alveolar infiltrates \[multi-lobar, lobar, or segmental\] containing air bronchograms).
4. Capable of giving signed informed consent

Exclusion Criteria

1. Any participant who develops signs and symptoms of pneumonia after being hospitalized for ≥48 hours (either at the study site, another transferring hospital, or a combination of these).
2. Received any pneumococcal vaccine ≤30 days prior to enrollment.
3. Unable to provide urine specimen (e.g. anuric).
4. Previous enrollment in the study within the past 30 days.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Kaiser Permanete Baldwin Park

Baldwin Park, California, United States

Site Status RECRUITING

Kaiser Permanete Downey

Downey, California, United States

Site Status RECRUITING

El Centro Regional Medical Center

El Centro, California, United States

Site Status RECRUITING

Kaiser Permanente Fontana Medical Center

Fontana, California, United States

Site Status RECRUITING

University of California San Francisco - Fresno

Fresno, California, United States

Site Status RECRUITING

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

Site Status RECRUITING

Kaiser Permanente

Los Angeles, California, United States

Site Status RECRUITING

Kaiser Permanente West Los Angeles Medical Center

Los Angeles, California, United States

Site Status RECRUITING

Kaiser Permanente Vaccine Study Center

Oakland, California, United States

Site Status RECRUITING

Kaiser Permanente Oakland Medical Center

Oakland, California, United States

Site Status RECRUITING

Kaiser Permanente Ontario Medical

Ontario, California, United States

Site Status RECRUITING

Southern California Permanente Medical Group (SCPMG)

Pasadena, California, United States

Site Status RECRUITING

Kaiser Permanente Riverside Medical Center

Riverside, California, United States

Site Status RECRUITING

Kaiser Permanente Roseville Medical Center

Roseville, California, United States

Site Status RECRUITING

Kaiser Permanente South Sacramento Medical Center

Sacramento, California, United States

Site Status RECRUITING

Kaiser Permanente Sacramento Medical Center

Sacramento, California, United States

Site Status RECRUITING

Kaiser Permanente Zion Medical Center

San Diego, California, United States

Site Status RECRUITING

Kaiser Permanente San Diego Medical Center

San Diego, California, United States

Site Status RECRUITING

Kaiser Permanente San Jose Medical Center

San Jose, California, United States

Site Status RECRUITING

Kaiser Permanente Santa Clara Medical Center

Santa Clara, California, United States

Site Status RECRUITING

Kaiser Permanente South San Francisco Medical Center

South San Francisco, California, United States

Site Status RECRUITING

Kaiser Permanente Walnut Creek Medical Center

Walnut Creek, California, United States

Site Status RECRUITING

Hartford Hospital

Hartford, Connecticut, United States

Site Status ACTIVE_NOT_RECRUITING

Starling Physicians

Hartford, Connecticut, United States

Site Status ACTIVE_NOT_RECRUITING

MedStar Washington Hospital Center

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

Site Status RECRUITING

Emory University Hospital Midtown

Atlanta, Georgia, United States

Site Status RECRUITING

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

Atlanta, Georgia, United States

Site Status RECRUITING

Emory University Hospital

Atlanta, Georgia, United States

Site Status RECRUITING