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

NCT05452941

RecruitingN/A

Sponsor: Pfizer

Conditions: Pneumonia

Interventions: Diagnostic test on urine samples

Countries: United States, Israel, Spain

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 overview

Sex: ALL

Age: 65 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
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.
Locations (54)
  • El Centro, California, United States
  • Fontana, California, United States
  • Los Angeles, California, United States
  • Oakland, California, United States
  • Oakland, California, United States
  • Ontario, California, United States
  • Pasadena, California, United States
  • Riverside, California, United States
  • Roseville, California, United States
  • Sacramento, California, United States
  • Sacramento, California, United States
  • San Diego, California, United States
  • San Diego, California, United States
  • Santa Clara, California, United States
  • South San Francisco, California, United States
  • Walnut Creek, California, United States
  • Hartford, Connecticut, United States
  • Washington D.C., District of Columbia, United States
  • Atlanta, Georgia, United States
  • Atlanta, Georgia, United States
  • Louisville, Kentucky, United States
  • Louisville, Kentucky, United States
  • Louisville, Kentucky, United States
  • Louisville, Kentucky, United States
  • Louisville, Kentucky, United States
  • Louisville, Kentucky, United States
  • Kenner, Louisiana, United States
  • New Orleans, Louisiana, United States
  • New Orleans, Louisiana, United States
  • Baltimore, Maryland, United States
  • + 24 more on CT.gov