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Clinical Trials in Spain / NCT05452941
Recruiting Observational

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

NCT05452941 · tracked via the Priya Life Science Spain tracker
Sponsor
Pfizer
Phase
Observational
Started
2022-10-27
Last updated
2026-05-11

Condition(s) studied

Pneumonia

Investigational drug(s) / intervention(s)

Diagnostic test on urine samples

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

Study 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.

Eligibility

Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (54)

FacilityCityRegionStatus
El Centro Regional Medical Center El Centro California Recruiting
Kaiser Permanente Fontana Medical Center Fontana California Recruiting
Kaiser Permanente West Los Angeles Medical Center Los Angeles California Recruiting
Kaiser Permanente Vaccine Study Center Oakland California Recruiting
Kaiser Permanente Oakland Medical Center Oakland California Recruiting
Kaiser Permanente Ontario Medical Center Ontario California Recruiting
Southern California Permanente Medical Group (SCPMG) Pasadena California Recruiting
Kaiser Permanente Riverside Medical Center Riverside California Recruiting
Kaiser Permanente Roseville Medical Center Roseville California Recruiting
Kaiser Permanente South Sacramento Medical Center Sacramento California Recruiting
Kaiser Permanente Sacramento Medical Center Sacramento California Recruiting
Kaiser Permanente Zion Medical Center San Diego California Recruiting
Kaiser Permanente San Diego Medical Center San Diego California Recruiting
Kaiser Permanente Santa Clara Medical Center Santa Clara California Recruiting
Kaiser Permanente South San Francisco Medical Center South San Francisco California Recruiting
Kaiser Permanente Walnut Creek Medical Center Walnut Creek California Recruiting
Starling Physicians Hartford Connecticut Active Not Recruiting
MedStar Washington Hospital Center Washington D.C. District of Columbia Recruiting
Emory Children's Center - Vaccine Research Clinic (ECC-VRC) Atlanta Georgia Recruiting
Emory University Hospital Atlanta Georgia Recruiting
University of Louisville School of Medicine, Division of Infectious Diseases Louisville Kentucky Recruiting
Robley Rex VA Medical Center Louisville Kentucky Recruiting
UofL Health, Mary & Elizabeth Hospital Louisville Kentucky Recruiting
Norton Audubon Hospital Louisville Kentucky Recruiting
Norton Brownsboro Hospital Louisville Kentucky Recruiting
Norton Women's and Children's Hospital Louisville Kentucky Recruiting
Ochsner Medical Center - Kenner Kenner Louisiana Recruiting
Ochsner Baptist Medical Center New Orleans Louisiana Recruiting
Ochsner Clinic Foundation New Orleans Louisiana Recruiting
University of Maryland Baltimore Maryland Recruiting
UMass Memorial Medical Center Worcester Massachusetts Recruiting
ECU Health Medical Center Greenville North Carolina Recruiting
UNC Hospitals Hillsborough Campus Hillsborough North Carolina Recruiting
Summa Health Clinical Research Center - Specialty Akron Ohio Recruiting
Summa Health Akron Ohio Recruiting
Ahuja Medical Center Beachwood Ohio Recruiting
University Hospitals Cleveland Medical Center Cleveland Ohio Recruiting
Kaiser Permanente Sunnyside Medical Center Clackamas Oregon Recruiting
Memorial Hermann Hospital Houston Texas Recruiting
Michael E. DeBakey VA Medical Center Houston Texas Recruiting

+ 14 more sites — see the full list on the official registry below.

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05452941 on ClinicalTrials.gov ↗ ← All trials in Spain