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

ConditionPneumonia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorPfizer

About this trial

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 criteria

Qualifiers

Male or female participants ≥65 years of age.

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,

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Diagnostic test on urine samples

Treatment groups

12,500 Participants
are divided into 2 treatment groups

Sponsors and collaborators