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

Recruitingn/aAges 65 Years - anyAllPfizer
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • Diagnostic test on urine samples
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Where

54 sites
El Centro Regional Medical Center
El Centro, United States
Kaiser Permanente Fontana Medical Center
Fontana, United States
Kaiser Permanente West Los Angeles Medical Center
Los Angeles, United States
Kaiser Permanente Vaccine Study Center
Oakland, United States
Kaiser Permanente Oakland Medical Center
Oakland, United States
Kaiser Permanente Ontario Medical Center
Ontario, United States
Southern California Permanente Medical Group (SCPMG)
Pasadena, United States
Kaiser Permanente Riverside Medical Center
Riverside, United States

…and 46 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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