Recruiting

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

Sponsor:

Pfizer

Code:

NCT05452941

Conditions

Pneumonia

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Diagnostic test on urine samples

Study Details

Brief 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.

Conditions

Pneumonia

Study ID

NCT05452941

Start date

Oct 27, 2022

Status verified date

May, 2026

Completion date

Jun 4, 2027

Anticipated

Primary completion date

Jun 4, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

12500 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Diagnostic test on urine samples

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

Primary outcome measure

Effectiveness of 20vPnC against all (invasive + non-invasive) RAD+CAP due to the 7 additional serotypes in 20vPnC beyond 13vPnC plus 15C [ Time Frame: 55 months ]

Central Contacts and Locations

Central contacts

Pfizer CT.gov Call Center

1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations

El Centro Regional Medical Center

Recruiting

El Centro, California, United States, 92243

Kaiser Permanente Fontana Medical Center

Recruiting

Fontana, California, United States, 92335

Kaiser Permanente West Los Angeles Medical Center

Recruiting

Los Angeles, California, United States, 90034

Kaiser Permanente Vaccine Study Center

Recruiting

Oakland, California, United States, 94612

Kaiser Permanente Oakland Medical Center

Recruiting

Oakland, California, United States, 96411

Kaiser Permanente Ontario Medical Center

Recruiting

Ontario, California, United States, 91761

Southern California Permanente Medical Group (SCPMG)

Recruiting

Pasadena, California, United States, 91101

Kaiser Permanente Riverside Medical Center

Recruiting

Riverside, California, United States, 92505

Kaiser Permanente Roseville Medical Center

Recruiting

Roseville, California, United States, 95661

Kaiser Permanente South Sacramento Medical Center

Recruiting

Sacramento, California, United States, 95823

Kaiser Permanente Sacramento Medical Center

Recruiting

Sacramento, California, United States, 95825

Kaiser Permanente Zion Medical Center

Recruiting

San Diego, California, United States, 92120

Kaiser Permanente San Diego Medical Center

Recruiting

San Diego, California, United States, 92123

Kaiser Permanente Santa Clara Medical Center

Recruiting

Santa Clara, California, United States, 95051

Kaiser Permanente South San Francisco Medical Center

Recruiting

South San Francisco, California, United States, 94080

Kaiser Permanente Walnut Creek Medical Center

Recruiting

Walnut Creek, California, United States, 94596

MedStar Washington Hospital Center

Recruiting

Washington D.C., District of Columbia, United States, 20010

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

Recruiting

Atlanta, Georgia, United States, 30322

Emory University Hospital

Recruiting

Atlanta, Georgia, United States, 30322

University of Louisville School of Medicine, Division of Infectious Diseases

Recruiting

Louisville, Kentucky, United States, 40202

Robley Rex VA Medical Center

Recruiting

Louisville, Kentucky, United States, 40206

UofL Health, Mary & Elizabeth Hospital

Recruiting

Louisville, Kentucky, United States, 40215

Norton Audubon Hospital

Recruiting

Louisville, Kentucky, United States, 40217

Norton Brownsboro Hospital

Recruiting

Louisville, Kentucky, United States, 40241

Norton Women's and Children's Hospital

Recruiting

Louisville, Kentucky, United States, 40241

Ochsner Medical Center - Kenner

Recruiting

Kenner, Louisiana, United States, 70065

Ochsner Baptist Medical Center

Recruiting

New Orleans, Louisiana, United States, 70115

Ochsner Clinic Foundation

Recruiting

New Orleans, Louisiana, United States, 70121

University of Maryland

Recruiting

Baltimore, Maryland, United States, 21201

UMass Memorial Medical Center

Recruiting

Worcester, Massachusetts, United States, 01655

ECU Health Medical Center

Recruiting

Greenville, North Carolina, United States, 27834

UNC Hospitals Hillsborough Campus

Recruiting

Hillsborough, North Carolina, United States, 27278

Summa Health Clinical Research Center - Specialty

Recruiting

Akron, Ohio, United States, 44304

Summa Health

Recruiting

Akron, Ohio, United States, 44304

Ahuja Medical Center

Recruiting

Beachwood, Ohio, United States, 44122

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Kaiser Permanente Sunnyside Medical Center

Recruiting

Clackamas, Oregon, United States, 97015

Memorial Hermann Hospital

Recruiting

Houston, Texas, United States, 77030

Michael E. DeBakey VA Medical Center

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

Pfizer

Last update posted

May 11, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Pfizer on 2026-05-11.