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
This trial does not accept healthy volunteersQualifiers
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 population
Males and females ages 65 and older hospitalized for suspected community acquired pneumonia.
Trial design
Treatments tested in this trial
Diagnostic test on urine samples
Diagnostic testTesting by BinaxNOW® S. pneumoniae and serotype-specific urine antigen detection (UAD) assays (UAD-1 and UAD-2).
Treatment groups
12,500 Participants
are divided into 2 treatment groupsGroup A: Case1 intervention
Group B: Control1 intervention
Trial outcomes
Primary outcomes
1
Effectiveness of 20vPnC against all (invasive + non-invasive) RAD+CAP due to the 7 additional serotypes in 20vPnC beyond 13vPnC plus 15C
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
Time frame
55 monthsSecondary outcomes
1
Effectiveness of 20vPnC against non-invasive RAD+CAP due to the 7 additional serotypes in 20vPnC beyond 13vPnC plus 15C
Vaccine effectiveness calculated as 1 minus the OR for 20vPnC vaccination among cases and controls multiplied by 100 adjusted for potentially confounding variables
Time frame
55 months2
Effectiveness of 20vPnC against all RAD+CAP due to any 20vPnC serotype plus 6C and 15C
Vaccine effectiveness calculated as 1 minus the OR for 20vPnC vaccination among cases and controls multiplied by 100 adjusted for potentially confounding variables
Time frame
55 months3
Effectiveness of 20vPnC against non-invasive RAD+CAP due to any 20vPnC serotype plus 6C and 15C
Vaccine effectiveness calculated as 1 minus the OR for 20vPnC vaccination among cases and controls multiplied by 100 adjusted for potentially confounding variables
Time frame
55 months4
Proportion of participants with RAD+CAP due to the 7 additional serotypes in 20vPnC beyond 13vPnC plus 15C, individually and aggregately
The proportion of participants with RAD+CAP who are positive for any of the 7 additional serotypes contained in 20vPnC beyond 13vPnC plus 15C as detected by UAD-2 or culture
Time frame
55 months Source ClinicalTrials.gov