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

Recruiting now

Conditions studied: Pneumonia

In brief

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.

Key facts

Study ID

NCT05452941

Run by

Pfizer

People needed

12500

Starts

2022-10-27

Expected to finish

2027-06-04

Last updated by the study team

2026-05-11

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female participants ≥65 years of age.
• 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).
• 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).
• Capable of giving signed informed consent

You may not qualify if…

• 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).
• Received any pneumococcal vaccine ≤30 days prior to enrollment.
• Unable to provide urine specimen (e.g. anuric).
• Previous enrollment in the study within the past 30 days.

Where it is running

• El Centro Regional Medical Center — El Centro, California, United States (enrolling)
• Kaiser Permanente West Los Angeles Medical Center — Los Angeles, California, United States (enrolling)
• Kaiser Permanente Fontana Medical Center — Fontana, California, United States (enrolling)
• Kaiser Permanente Oakland Medical Center — Oakland, California, United States (enrolling)
• Kaiser Permanente Ontario Medical Center — Ontario, California, United States (enrolling)
• Southern California Permanente Medical Group (SCPMG) — Pasadena, California, United States (enrolling)
• Kaiser Permanente Vaccine Study Center — Oakland, California, United States (enrolling)
• Kaiser Permanente Roseville Medical Center — Roseville, California, United States (enrolling)
• Kaiser Permanente South Sacramento Medical Center — Sacramento, California, United States (enrolling)
• Kaiser Permanente Sacramento Medical Center — Sacramento, California, United States (enrolling)
• Kaiser Permanente Zion Medical Center — San Diego, California, United States (enrolling)
• Kaiser Permanente San Diego Medical Center — San Diego, California, United States (enrolling)
• Kaiser Permanente Santa Clara Medical Center — Santa Clara, California, United States (enrolling)
• Kaiser Permanente South San Francisco Medical Center — South San Francisco, California, United States (enrolling)
• Kaiser Permanente Walnut Creek Medical Center — Walnut Creek, California, United States (enrolling)
• Kaiser Permanente Riverside Medical Center — Riverside, California, United States (enrolling)
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States (enrolling)
• Emory Children's Center - Vaccine Research Clinic (ECC-VRC) — Atlanta, Georgia, United States (enrolling)
• Emory University Hospital — Atlanta, Georgia, United States (enrolling)
• University of Louisville School of Medicine, Division of Infectious Diseases — Louisville, Kentucky, United States (enrolling)
• Robley Rex VA Medical Center — Louisville, Kentucky, United States (enrolling)
• UofL Health, Mary & Elizabeth Hospital — Louisville, Kentucky, United States (enrolling)
• Norton Audubon Hospital — Louisville, Kentucky, United States (enrolling)
• Norton Brownsboro Hospital — Louisville, Kentucky, United States (enrolling)
• Norton Women's and Children's Hospital — Louisville, Kentucky, United States (enrolling)

Full record on ClinicalTrials.gov

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