Observational Study of 20-Valent Pneumococcal Conjugate Vaccine for Pneumonia

This study aims to understand how well the 20-valent pneumococcal conjugate vaccine (20vPnC) protects against pneumonia caused by specific types of bacteria (serotypes) not covered by an older vaccine. You may be able to join if you are 65 years or older, are currently in the hospital with suspected community-acquired pneumonia (CAP), and your pneumonia is confirmed by imaging like a chest X-ray. The study will look at how effective 20vPnC is against pneumonia caused by the 7 new serotypes included in this vaccine. The current status of this study is unclear.

Study design
This is an observational study involving 12,500 participants. It uses a "test-negative" design, comparing those with specific pneumonia types to those without.
What's involved
You will be asked to provide your demographic and medical history. You will also provide a urine sample for testing.
Compensation
Not stated in the trial record.
Follow-up
The effectiveness of the vaccine will be measured at 55 months.

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NCT05452941

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

Recruiting
Not specifiedAges 65+Observational
Pfizer
~12,500 participants
Updated 2026-05-11 on ClinicalTrials.gov
What's tested:Diagnostic test on urine samples

At a glance

Recruiting sites
53 of 54 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Effectiveness of 20vPnC against all (invasive + non-invasive) RAD+CAP due to the 7 additional serotypes in 20vPnC beyond 13vPnC plus 15C
Measured over 55 months
Pneumonia
54 sites across 18 states
California16
Kentucky6
Spain5
Ohio4
Israel4
Louisiana3
Georgia2
North Carolina2
  • Pfizer CT.gov Call Center · STUDY_DIRECTOR · Pfizer

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
  • Effectiveness of 20vPnC against all (invasive + non-invasive) RAD+CAP due to the 7 additional serotypes in 20vPnC beyond 13vPnC plus 15C55 months

    Vaccine effectiveness as calculated as 1 minus the odds ratio for 20vPnC vaccination among cases vs. controls multiplied by 100 adjusted for potentially confounding variables