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

Launched by PFIZER · Jul 6, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how effective the 20-valent pneumococcal conjugate vaccine (20vPnC) is in preventing pneumonia caused by specific strains of bacteria in real-world situations. The researchers want to see how well this vaccine works for older adults who are hospitalized with pneumonia. They are particularly interested in learning about the new types of bacteria that are included in this vaccine.

To participate in the study, you must be at least 65 years old and be hospitalized with pneumonia confirmed by a chest x-ray. If you join, you will provide some basic health information and a urine sample to help identify the bacteria causing your pneumonia. The study will last about 1-2 days, and researchers will also look at your medical records for up to 30 days after your hospitalization to gather more information about your illness. This trial is currently recruiting participants, and it's important to note that you cannot have had a pneumococcal vaccine in the last 30 days or developed pneumonia after being hospitalized for more than 48 hours.

Gender

ALL

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.